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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

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

• 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

• 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

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

•  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 Formulation for freeze drying, development and applicability

Paul Matejtschuk

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

Increasing complexities of myriad pharmaceutical products and materials demand improved and novel methods that characterise and consequently provide essential information to support formulation design.
• Formulation choice and its impact
• Analytical methods - what can they tell us?
• Understanding and applying Design of Experiments (DoE) in formulations
• Assessing the influence of moisture content in lyophilised products
 

14:00 Low Temperature Drying Processes for Biopharmaceuticals

Sune Klint  Andersen

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

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

14:40 Afternoon Tea

15:10 Micro freeze-dryers: a valuable tool for process design

Davide Fissore

Davide Fissore, Professor, Politecnico Di Torino

• Micro freeze-dryers may be used to design a freeze-drying process requiring a very low amount of drug;
• A temperature-controlled aluminum ring, in contact with the external vials of the batch, is effective in obtaining uniform drying conditions;
•  By a careful selection of the temperature of the ring it is possible to reproduce in the small-scale unit the drying conditions of central or edge vials in a larger scale dryer;
• Model parameters may be estimated through the small-scale freeze-dryer, thus enabling in-silico process simulation for design space calculation and process optimization.
 

15:50 Analysing current strategies in vaccine formulation design to achieve improved stability for long term storage and distribution

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

9:10 Ever tried. Ever failed. No matter. Try again. Fail again. Fail better! A (more) rational approach to lyo cycle development.

Michael Dekner

Michael Dekner, Head of Fill & Finish Life cycle management support, Takeda

• Use of modelling for rational lyo cycle design
• Vial heat transfer and cake resistance
• Experimental setup
• Lessons learned
 

9:50 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

• 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
 

10:30 Morning Coffee

11:00 Assessment of Aggregation in Lyophilised Biologics

Paul Barry

Paul Barry, Development Scientist, Sanofi

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

11:40 A proposed scientific rationale for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers

Aled  Jones

Aled Jones, Manufacturing Support Manager, Biopharm Ltd.

• 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. 

 

12:20 Networking Lunch

13:20 Optimisation of industrial freeze-drying cycle - Two real life examples

Mostafa Nakach

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

• 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
 

14:00 Current developments in Through-Vial Impedance Spectroscopy as an accurate process analytical tool for lyophilization

Geoff Smith

Geoff Smith, Professor of Pharmaceutical Process Analytical Technology, DeMontford University

Monitoring essential parameters during the lyophilization process remains an ongoing challenge particularly in a non-invasive fashion. Through vial impedance spectroscopy (TVIS) successfully achieves noninvasive, real time, in-line measurement of the bulk electrical properties of the lyophilized product over the course of freezing and drying steps. This technology ensures there is no impact on nucleation temperature, ice crystal formation and drying kinetics and recent advances in TVIS will also be discussed.

• An introduction to impedance spectroscopy and TVIS
• Applications of TVIS technology
• Design space characterization and assessment
 

14:40 Afternoon Tea

15:10 Facilitating lyophilisation of sensitive biomolecules through the use of microwave-assisted freeze drying technology

15:50 Evaluating the challenges of highly concentrated biological formulations to minimise issues

17:00 Chairman’s Closing Remarks and Close of Day Two

+

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. 

HOTEL BOOKING FORM

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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. 

HOTEL BOOKING FORM

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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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