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SMi Group announces the return of the 7th Annual Lyophilisation Conference taking place on the 3rd and 4th June 2019, in London, UK.


Lyophilisation (or freeze drying) remains one of the most exciting and rapidly advancing technologies in the pharmaceutical industry to date. By 2020, the lyophilisation equipment market is projected to exceed 8% CAGR reaching approximately £4.4 billion. With up to a third of all FDA-approved parenterals and almost half of all injectables expected to be lyophilised in the near future, significant strides toward better standards and regulation are also anticipated to follow suit.


Despite being a relatively old process, lyophilisation continues to raise challenges in conjunction with ever changing biopharmaceutical products that carry their own set of inherent complexities. Join us along with key opinion leaders from all areas of pharmaceuticals and biologicals to explore formulation science, materials characterisation, novel and alternative technologies, mathematical modelling and regulatory updates. 


 

Participating in this year’s Lyophilisation 2019 conference provides a chance to connect with research and industry leaders with the aim of tackling the most pressing hurdles in multiple areas of interest within lyophilisation:
 

  • Scrutiny of product complexity via material characterisation with the intention of gaining a deeper understanding of formulation design and its development.
  • Assessing the essential factors and fitting mechanical investment for successful scale up and tech transfer
  • Utility of appropriate process analytical technology tools for process monitoring, optimisation and lyophilisation cycle development
  • Conducting accurate modelling and estimation for prediction and risk reduction.
  • Exploring developing technologies and alternatives to traditional lyophilisation techniques

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:

  • Lyophilisation/Freeze-drying
  • Formulation Scientists
  • Principal Scientist
  • Process Development/Engineer
  • Sterile/Fill-Finish
  • Production
  • PAT
  • CMC
  • Chemistry
  • Manufacturing
  • Quality Assurance/QA

Amatisgroup; Arlenda; Aznil Telstar Technologies, SLU; Abbott Healthcare Products BVá; BioNTech; Baxter SA; Bayer A G; Biofire Diagnostics; Biopharma Group; BioPharma Technology; Boehringer Ingelheim; Boehringer-Ingelheim; Bristol-Myers Squibb; BSP PHARMACEUTICALS Srl; BUCHI UK Ltd ; DeMontford University; DSM; Ferring Pharmaceuticals A/S; Fresnius Kabi Austria GmbH; F. Hoffman-La Roche Ltd.; GEA Process Engineering; Genzyme Ireland Ltd; GlaxoSmithKline; GlaxoSmithKline plc; GSK; GSK Manufacturing S.p.A.; Hosokawa Micron BV; Imperial College London; LFB Technology; INDATECH SAS; Janssen Pharmaceutica NV; MedImmune; MedImmune Inc.; Merck KGaA; Mylan; NIBSC; Novo Nordisk; OPTIMA pharma GmbH; Pacifi Ltd; Pfizer Inc; Pliva Croatia Ltd; RheaVita BV; Roche; Roche Pharmaceuticals; Sandoz GmbH; Syngenta Limited; TEVA Pharmaceuticals; University College Cork (UCC); University Of Central Lancashire; University of Ghent; Vetoquinol SA; Xellia Pharmaceuticals ApS;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Xiaodong Chen

Xiaodong Chen, Senior Research Investigator , Bristol-Myers Squibb
View Bio

9:10 Recent advances in technologies and approaches in freeze-drying: a quick tour

Kevin Ward

Kevin Ward, Director of Research and Development, BioPharma Technology
View Bio

• Formulation characterisation – freeze-drying microscopy and thermal analysis
• Process monitoring and control – PAT and controlled nucleation methods
• Approaches, limitations and practicalities in scaling up the freeze-drying process
• Post-lyophilisation testing – new technologies for understanding the final product
 

9:50 Anatomy of the Lyophilization Process: Considerations for a Successful Tech Transfer

Anthony Cannon

Anthony Cannon, Regional Director, ExM, GTO Bio/Sterile European Region, MSD
View Bio

• Tech transfer of a lyophilized product
• Overview of the lyophilization process and the critical process parameters
• Specific focus on the technical considerations with analysis of the impact on the lyophilization recipe
• Impact of deviations to the CPPs on the product quality during transfer activities
 

10:30 Morning Coffee

11:00 Representative Scale-down Lyophilization Cycle Development Using a Micro Freeze-Dryer

Xiaodong Chen

Xiaodong Chen, Senior Research Investigator , Bristol-Myers Squibb
View Bio

A scale-down lyophilizer was used to simulate at-scale lyophilization development and optimization. Equivalent lyophilization performance between the scale-down lyophilizer and a laboratory lyophilizer were demonstrated for placebo and mAb drug products. By changing the MicroFD® Kv, laboratory, and potentially manufacturing cycles, may be simulated using this lyophilizer for tremendous API savings:
• The MicroFD® is designed with precision machined, temperature controlled aluminium blocks that make direct contact with the outer vials. These blocks are designed to mimic vial-to-vial contacts that control inter vial heat transfer
• Demonstrated the ability to fine-tune the MicroFD® heat transfer coefficient (Kv) to match the Kv of vials in a Lyostar III laboratory scale unit
• The resulting performance between scales results in equivalent product primary drying times, product temperature profiles, and critical quality attributes (CQAs)
• A workflow is proposed using the scale-down lyophilizer to simulate at-scale lyophilization development and optimization. 

 

11:40 Preventing Cross Contamination during Lyophilization

Richard Denk

Richard Denk, Head Sales Containment, SKAN AG
View Bio

•  What are highly potent/toxic Biopharmaceutical Products
•  What are the GMP and Occupational Safety Requirements
•  How to prevent Product Contamination during loading the Lyo
•  Cleaning Requirements and Occupational Safety Requirements
 

12:20 Networking Lunch

13:20 A proposed scientific rationale for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers

Aled  Jones

Aled Jones, Manufacturing Support Manager, Ipsen Biopharm Ltd.
View Bio

• A methodology has been developed to determine the theoretical quantity of air that could leak into a pharmaceutical freeze dryer based on vacuum pressure increase.
• Based on the potential maximum bioburden and particulate level of the leaked air from potentially unclassified areas, simple calculations can be undertaken to determine the maximum allowable leak rate that will still maintain Class 100 / Grade A conditions for the duration of the lyophilisation cycle.
• It will be shown that the 2 x 10-2 mbar-litre/sec specification, that is frequently quoted as the acceptable leak rate for modern pharmaceutical freeze dryers may not be appropriate to maintain Grade A conditions for freeze dryers of differing volumes with lyophilisation cycles of differing lengths.
• This methodology can then be used as a justification for the setting of leak rate limits for new cycles or freeze dryers based on potential microbial risk rather than equipment process capability. 

 

14:00 Application of Infrared Thermography and Multivariate Image Analysis for the on-line Monitoring of a Freeze-Drying Process

Davide Fissore

Davide Fissore, Professor, Politecnico Di Torino
View Bio

• Infrared camera, placed inside a freeze-dryer, can be used to monitor product temperature in several vials, in different positions.
• Product temperature measurement may be used to infer the residual amount of ice in the primary dying stage, as well as the parameters of a simple one-dimensional model of the process.
• The system may be used also to track the evolution of the product in the freezing stage.
• Using Multivariate Image Analysis (MIA) it becomes possible to extract additional information about process dynamics.
• The proposed MIA-based PAT system is able to efficiently detect undesired events occurring during the process.
• Information obtained through a standard RGB camera may be also include in the PAT system.
 

14:40 Afternoon Tea

15:10 Optimisation of industrial freeze-drying cycle - Two real life examples

Mostafa Nakach

Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
View Bio

• Comparing two dated lyophilized products (60’s) with historical cycles that exhibit distinct complications
• Development and optimization of manufacturing processes to overcome the lack of physical chemistry data from dated products
• Applying product knowledge, new freeze dryer knowledge, simulation and process modelling
 

15:50 In silico evaluation of intermolecular interactions in the pharmaceutical formulations during freeze-drying processes

Mire  Zloh

Mire Zloh, Honorary Professor, University of Hertfordshire
View Bio

• In silico methods can predict intermolecular interactions between components of pharmaceutical formulations.
• A combination of molecular docking and molecular dynamics simulations methods provides insights into the protective effects of formulations on a molecular level.
• Such information can guide the computer aided development of future formulations. 

 

16:30 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sune Klint  Andersen

Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV
View Bio

9:10 Low Temperature Drying Processes for Biopharmaceuticals

Sune Klint  Andersen

Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV
View Bio

• Challenges in drying of biopharmaceuticals
• Drying process landscape and trends
• Emerging low temperature drying processes
 

9:50 Primary Drying endpoint determination

Bert Van Meervenne

Bert Van Meervenne, Senior Principal Scientist, Pfizer Manufacturing
View Bio

• Overview & discussion of different tools to determine primary drying endpoint
• Pros and Cons of each method
• Touching briefly additional potential of these tools
 

10:30 Morning Coffee

11:00 Applications for Impedance Spectroscopy in the Determination of In-Vial Phase Behaviour

• Through Vial Impedance Spectroscopy – An Introduction
• Dielectric loss mechanisms in frozen solutions
• Measurement frequency selection for different facets of the freezing process (ice nucleation to solidification end point)
• Determination of in-vial glass transitions and collapse phenomena

 

Geoff Smith

Geoff Smith, Professor of Pharmaceutical Process Analytical Technology, DeMontfort University
View Bio

11:40 Formulation for freeze drying, development and applicability

Paul Matejtschuk

Paul Matejtschuk, Principal Scientist & Section Head, Standardisation Science, NIBSC
View Bio

Increasing complexities of myriad pharmaceutical products and materials demand improved and novel methods that characterise and consequently provide essential information to support formulation design.
• How does freeze drying impact bio activity?
• Role of Design of Experiments in formulation development
• Using PAT tools - through vial impedance as an example

 

12:20 Networking Lunch

13:20 Long-Term Storage Stability and Effect of Moisture Content on Freeze-Dried Immunoglobulin G (IgG)

Daryl Williams

Daryl Williams, Director of Development, Chem. Eng. Discovery, Imperial College London
View Bio

• High protein concentration products for targeted therapeutic use are commonly manufactured by freeze-drying. 
• The long-term storage stability of freeze-dried plasma derived Immunoglobulin G (IgG) from moderate to high concentrations (1, 5, 10 and 20 % w/v) was assessed for -20°C, 20°C, 45°C
• At -20°C < 1% of monomer loss, 20C <5% monomer loss, whilst 45°C a 15%-39% decrease in monomer concentration
• Moisture content in vial effected formulation stability
 

14:00 Assessment of Aggregation in Lyophilised Biologics

Paul Barry

Paul Barry, Development Scientist, Sanofi
View Bio

• Using large data sets to identify common cause(s) for aggregation occurrence.
• Analytical assessment of aggregation
 

14:40 Current state of MTM – True PAT with high future potential

Georg Frinke

Georg Frinke, Process Engineer, Bayer AG
View Bio

• Current state of MTM Technology
• Operating principle
• Future potential & Limitations

 

15:20 Chairman’s Closing Remarks, Afternoon Tea and Close of Day Two

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FEATURED SPEAKERS

Aled  Jones

Aled Jones

Manufacturing Support Manager, Ipsen Biopharm Ltd.
Anthony Cannon

Anthony Cannon

Regional Director, ExM, GTO Bio/Sterile European Region, MSD
Bert Van Meervenne

Bert Van Meervenne

Senior Principal Scientist, Pfizer Manufacturing
Daryl Williams

Daryl Williams

Director of Development, Chem. Eng. Discovery, Imperial College London
Davide Fissore

Davide Fissore

Professor, Politecnico Di Torino
Geoff Smith

Geoff Smith

Professor of Pharmaceutical Process Analytical Technology, DeMontfort University
Georg Frinke

Georg Frinke

Process Engineer, Bayer AG
Kevin Ward

Kevin Ward

Director of Research and Development, BioPharma Technology
Mire  Zloh

Mire Zloh

Honorary Professor, University of Hertfordshire
Mostafa Nakach

Mostafa Nakach

Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
Paul Barry

Paul Barry

Development Scientist, Sanofi
Paul Matejtschuk

Paul Matejtschuk

Principal Scientist & Section Head, Standardisation Science, NIBSC
Richard Denk

Richard Denk

Head Sales Containment, SKAN AG
Sune Klint  Andersen

Sune Klint Andersen

Principal Scientist Spray Drying , Janssen Pharmaceutica NV
Xiaodong Chen

Xiaodong Chen

Senior Research Investigator , Bristol-Myers Squibb

Aled Jones

Manufacturing Support Manager, Ipsen Biopharm Ltd.
Aled  Jones

Dr Aled Jones is the Manufacturing Support Manager for Ipsen Biopharm Ltd and responsible for a team of technical specialists supporting API and sterile fill finish in the manufacturing facility. Dr. Jones received his PhD in solid state physics from King’s College London and has previously worked in the chemical and aerospace industries.

Anthony Cannon

Regional Director, ExM, GTO Bio/Sterile European Region, MSD
Anthony Cannon

Tony is currently Regional Director of Global Technical Operations, External Manufacturing for Sterile Products at MSD International located in Lucerne, Switzerland. He is responsible for all technical support of sterile drug products for external manufacturing operations for the European Region. He has held various positions throughout his career in Sterile Drug Product development and manufacturing with a focus on formulation and process development of both liquid and lyophilized parenterals, final container development and optimization, medical devices and drug delivery. He has over 20 years’ in the industry with experience in biologics (plasma products, proteins, peptides, liposomes, vaccines; viral and bacterial), small molecules, nanocrystals, medical devices, reagents, nutriceuticals and cytotoxics, focused on lyophilization development and manufacturing. He has also presented on the fundamental of lyophilization, formulation, process development, thermal characterization, finished product analysis, and scale up and tech transfer at various conferences, seminars and pharmaceutical and biotech companies in North America, Europe and Asia.

Bert Van Meervenne

Senior Principal Scientist, Pfizer Manufacturing
Bert Van Meervenne

Born in 1966 in Temse (Belgium), graduated in 1989 as a Chemical Engineer with focus on Processing Techniques.
Joined Pfizer (Upjohn at that time) in 1991 and worked in aseptic production until 2017, covering formulation, autoclaving, stopper processing, filling and visual inspection, but the larger part of this period (+20 years) the main focus was on commercial lyophilization.
From 2017 on working on lyophilization in Pfizer GT&E (global technology and engineering), mostly involved in product transfers and problem solving.
 

Daryl Williams

Director of Development, Chem. Eng. Discovery, Imperial College London
Daryl Williams

Dr. Daryl R. Williams graduated with a B.Sc. (Hons) in Physical Chemistry from University of Melbourne, Australia and a M.Sc. in Polymer Science from Lehigh University, USA before coming to Imperial College London complete his PhD. He is currently the Director of the Discovery Space and a Professor in Particle Science in the Department of Chemical Engineering.
DRW has published over 90 papers in refereed journals and been granted international 5 patents. His research interests include the surface and bulk characterisation of complex organic solids, including especially biopharmaceutics, foods, pharmaceuticals and polymers as well as their manufacture using spray drying, crystallisation, freeze drying, milling and granulation. The Surface and Particle Engineering Laboratory he leads has 4 Postdoctoral research fellows and 10 PhD students. He has invented and has led the commercialisation of two standard techniques for materials characterisation, the Dynamics Vapour Sorption (DVS) and the Inverse Gas Chromatography (IGC) methods.
 

Davide Fissore

Professor, Politecnico Di Torino
Davide Fissore

Davide Fissore is Professor of Advanced Process Control and Food Processing Technologies at Politecnico di Torino (Italy), leader of the Process System Engineering group. His research activity is mainly focused on process modelling and on the design and validation of advanced model-based tools for process monitoring and control. The field of this research comprises the freeze-drying of pharmaceutical products and foodstuffs. Prof. Fissore acted as principal investigator in several research projects granted by pharmaceutical and food companies focused on the design and optimization of batch freeze-drying processes, and on the development of model-based Process Analytical Technologies.

Geoff Smith

Professor of Pharmaceutical Process Analytical Technology, DeMontfort University
Geoff Smith

Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focusses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such as laser speckle and optical flow.
He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates and end points. This development marks the first time that impedance spectroscopy has been used to characterize materials within conventional glass freeze-drying vials, without having to insert the electrodes into the product (i.e. the solution under-going freeze-drying). This feature of the technology sets it apart from other in-process impedance measurement systems, in which a bulky electrode assembly is inserted into the solution being freeze-dried, to provide a product-non-invasive technology.
 

Georg Frinke

Process Engineer, Bayer AG
Georg Frinke

Georg holds a degree in Engineering from the Technical University, Cologne, Germany. He is Process Engineer at Bayer Pharma (Leverkusen) and responsible for the technical operation of the Parenteral production in Leverkusen. Previously, he worked as Process Engineer for the R&D Facility F2P2 (JnJ/Cilag Schaffhausen) and at supplier side for Optima (Klee) and GEA Lyophil (former Steris). He is specialized in design, qualification and operation of pharmaceutical freeze dryers under GMP-conditions.

Kevin Ward

Director of Research and Development, BioPharma Technology
Kevin Ward

Kevin Ward began his career in freeze-drying in 1993 with a PhD on protein and liposome stabilisation and the thermal properties of lyophilised amorphous and crystalline mixtures. After working in the pharmaceutical industry and in vaccine development, he joined Biopharma in 2000. As R&D Director, he has built up a team of dedicated freeze-drying scientists, worked on over 2500 projects for more than 500 client companies across the globe, developed 3 analytical instruments, run more than 180 training courses, and successfully secured EU- and UK- government funding for 15 novel research projects. He has appeared on BBC television for his team’s work on the preservation of red blood cells and been an advisor to the BBC for one of their popular science shows. Kevin is a Fellow of the Royal Society of Chemistry and from 2000-2014, he was part of a not-for-profit focus group at the Pharmaceutical and Healthcare Sciences Society (formerly the Parenteral Society) that produced a series of technical monographs to support users of freeze-dryers, and he chaired the group from 2007-2014. Kevin has been industrial supervisor to two doctoral students, and has authored numerous papers, book chapters and patents. He continues to lecture on the worldwide stage and has co-edited a text book that was published in January 2019 on new te= in freeze-drying.

Mire Zloh

Honorary Professor, University of Hertfordshire
Mire  Zloh

Mire Zloh is an Honorary Professor at the UCL School of Pharmacy. Previously, Prof. Zloh has worked as Research Professor and Head of Pharmaceutical Chemistry at the University of Hertfordshire as well as a Senior Lecturer and Director of the Centre for Structural Chemistry at the UCL School of Pharmacy. He was awarded an MSc in Physical Chemistry by the University of Belgrade and earned a PhD in Chemistry at the University of London. Prof. Mire Zloh has authored more 110 scientific publications and reviews. His research interests include drug design, structural chemistry and rational development of dendrimers as drug delivery systems. He is currently working on the method development for computer-aided design of formulations.

Mostafa Nakach

Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
Mostafa Nakach

Mostafa Nakach is PhD from Toulouse University. He has prepared his thesis on stabilization and production of nanocrystalline suspension. He is also Master 2 graduate from Paris-sud 11 university in Pharmacotechnie and Biopharmacy and Pharmaceutical engineer from Ecole des Mines d’Albi . Mostafa is working within sanofi group since 31 years. His current position is a head of formulation and process development section within Biologics drug product development.
His mission is to build and to manage the required skills and capabilities in order to support R&D projects development mainly for Fill&finish Commercial process development of biotech products including freeze drying.
 

Paul Barry

Development Scientist, Sanofi
Paul Barry

Having obtained a PhD in Biochemistry in 2017 from Trinity College Dublin, and working as a Technical Specialist at Abbott Diagnostics, I joined Sanofi in 2018. I am part of the state of the art Lyophilisation MSAT group at Sanofi Waterford, working as a Development Scientist primarily on NPI activities and manufacturing support.

Paul Matejtschuk

Principal Scientist & Section Head, Standardisation Science, NIBSC
Paul Matejtschuk

Paul Matejtschuk PhD, CChem, FRSC is a Principal Scientist, and leads the Standardization Science Section at the National Institute for Biological Standards & Control (NIBSC), a Unit of the Medicines and Healthcare products Regulatory Agency, whose mission is to safeguard the quality of biological medicines. NIBSC is also designated a WHO International Laboratory for Biological Standardization.

His team is focused on delivering formulation and lyophilization conditions for a wide range of biological reference materials and his research interests include the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. http://www.nibsc.org/about_us/staff_profiles/dr_paul_matejtschuk.aspx

Paul has over 30 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk)

He has co-supervised several PhD studentships, published and lectured widely in the field and has recently co-edited a book on freeze drying with Dr Kevin Ward ( Lyophilization of Pharmaceuticals and Biologicals, New Technologies & Approaches, Ward KR & Matejtschuk P, Springer Press, 2019).
 

Richard Denk

Head Sales Containment, SKAN AG
Richard Denk

Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP (Sterile Product Processing) CoP. Furthermore Mr. Denk founded the PDA Expert Group about Cleaning and Cross Contamination Requirements for Biopharmaceutical Products and published this topic as PDA Paper. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Sune Klint Andersen

Principal Scientist Spray Drying , Janssen Pharmaceutica NV
Sune Klint  Andersen

Principal Scientist in Particle Engineering, Janssen Research & Development, Belgium.

Ph.D. in Chemical Engineering – Nanoparticle Technology
MBA in Management & Technology

Main interests and professional experience include development of drying processes for biopharmaceuticals, small & large molecules, drug substance & product, excipients, scale-up. Furthermore, application of Quality-by-Design in drying processes, validation and qualification of spray dryers, advantages & disadvantages of spray vs freeze drying processes, continuous manufacturing, mathematical modelling of drying processes, aseptic spray drying, particle engineering, innovative drying processes and enabling technologies.

Been with Janssen since Apr-2017 and before that 10 years at Novo Nordisk (spray and freeze drying of peptides & proteins) and 8 years with GEA Niro A/S (spray drying, fluid bed drying, equipment design).
 

Xiaodong Chen

Senior Research Investigator , Bristol-Myers Squibb
Xiaodong Chen

Xiaodong Chen is working as a senior research investigator at BMS. He is a drug product development team leader who is responsible for developing, recommending and implementing development strategies of biologics drug product formulation, device and primary packaging, tech transfer to commercial manufacturing, registrational filing. Xiaodong is also leading the efforts of developing computational models to optimize lyophilization cycles of commercial products (NULOJIX®, EMPLICITI™) as well as developing lyo cycles for late stage biological and small molecule parenteral drug products. Xiaodong has co-authored two book chapters and a number of publications in this field. In addition, he is on the editorial advisory board of Journal of Pharmaceutical Sciences and invited reviewer for NIH contract proposals. He has advised two NSF funded projects and served as session chairs in AiChe and AAPS Annual Conferences. Xiaodong received his Ph.D. from the Ohio State University.

Exhibitors

Supporters

Workshops

From Physical Properties to Lyophilised Product
Workshop

From Physical Properties to Lyophilised Product

Holiday Inn Kensington Forum
5th June 2019
London, United Kingdom

VENUE

Holiday Inn Kensington Forum

97 Cromwell Road , London, United Kingdom

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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Lyophilisation 2019 Attendee List

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Interview with Geoff Smith, De Montfort University

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Speaker Interview with Xiaodong Chen, Bristol-Myers Squibb

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In silico approaches to aid rational design of freeze dried formulations

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Lyophilisation 2019 Full Programme

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Lyophilisation 2019 Workshop Programme

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Lyophilization of an Oral Anti-Viral Agent

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Humidity Induced Collapse in Freeze Dried Cakes: A Direct Visualization Study using DVS

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Snap Shot of Attendees at Lyophilisation 2018

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Lyophilisation 2019 Speaker Line Up

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Lyophilisation 2019 Conference Brochure

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Exhibitors


Testo

Exhibitors
https://www.testo.com/en-UK/

The validation of sterilization and freeze-drying processes is a key element of your quality assurance and shows the high level of safety of the products you make. With our testo 190 CFR data logger system, we support you according to your needs in terms of fulfilling all regulatory requirements in a highly efficient way.

Media Partners


pharmanews hq

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MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


World Pharma News

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IPI

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IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


Lyophilization World

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Lyophilization World is a global platform in the field of lyophilization and freeze drying technology. Follow us to be informed in a unique way about current solutions, future trends and news in lyophilization


Pharmaceutical Technology

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Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


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pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


Pharmalicensing

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Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


Drug Discovery Today

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Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.

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Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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