Cambridge Healthtech Institute’s Inaugural

Formulation, Stability & Aggregation

Improving and Accelerating Protein Production Processes

March 25-26, 2020

 

This inaugural conference brings together leading industry experts to advance formulation, stability and aggregation studies in the production of traditional and novel biotherapeutics. Exploring the latest methods, technologies and solutions being employed to overcome your most pressing challenges. We invite you to join us in Barcelona to share best practices with like-minded peers.

Final Agenda

Wednesday, 25 March

10:30 Registration

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

PLENARY SESSION:
NEXT-GENERATION PROCESSES AND PRODUCTS

11:15 Chairperson’s Opening Remarks

Jarka Glassey, PhD, Professor, Chemical Engineering, Engineering, Newcastle University

11:20 Current Opportunities and Challenges in Biotherapeutic CMC

Schumacher_RalfRalf Schumacher, PhD, Global Head, Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG

As biologic pipelines continue to grow and diversify, there is an increasing need to standardize, automate and find efficiencies along the entire value chain. This presentation will discuss the current challenges and opportunities in biotherapeutic CMC and the impact new modalities are having on upstream and downstream processing, analytics and formulation. The advantages of predictive process parameters in early stage development and digital development concepts to speed up the CMC development will also be discussed.

11:50 Gene Therapy Manufacturing and Technical Development

Blumenthal_DianeDiane Blumenthal, PhD, Head, Technical Development, Spark Therapeutics

In the past few years, several cell and gene therapy products have gained regulatory approval in the US and EU with many more in the pipeline. Manufacturers of cell and gene therapy products must tackle technological challenges under the pressure of short timelines resulting from streamlined clinical development. This presentation will focus on the key technical development challenges facing the industry as product development programs move the into the later stages of process development and scale-up, process performance qualification and ultimately commercialization.

12:20 Session Break

12:30 BRIDGING LUNCHEON PRESENTATION: Demystifying Label-Free Techniques and Applications for High-Quality Data in a Fraction of the TimeForteBio

Schnerr_HelgeHelge Schnerr, PhD, FortéBio - Molecular Devices (Germany) GmbH

Cell line development includes the screening of thousands of clones. The aim is to find the few that are stable, grow as expected, and produce high yields of the bioproduct.  Speed up antibody discovery and development by moving higher quality candidates downstream. How? Carry out expression level analysis label-free in crude samples. Combine it with early-stage glycan characterization both in a high-throughput mode.

13:00 Session Break

OPTIMISING FORMULATION DEVELOPMENT

13:45 Chairperson’s Remarks

Shahid Uddin, Director, Drug Product, Formulation & Stability, Immunocore

13:50 Formulation and Analytical Development Strategies for Bispecifics

Dubey_SachinSachin Dubey, PhD, Deputy Director, Process Sciences, Ichnos Sciences SA

More than 130 clinical trials are currently ongoing with different formats of bispecifics. They are relatively new and through challenges by virtue of differences in formats – standard platform approach cannot be applied in majority of cases. Developing analytics first to understand the molecules and then to establish analytical release panel is a challenging task requiring careful planning. Formulation development especially for very low concentration FIH is equally demanding.

14:20 New Approaches to Profiling the Solution Behaviour of Therapeutic Proteins

McCoy_MarkMark McCoy, PhD, Principal Scientist, Screening, Target and Compound Profiling, Merck & Co

Protein self-interactions are an intrinsic behaviour that can adversely affect the developability of therapeutic proteins. Our recent work on NMR-based interaction & behaviour assessments permits the simultaneous detection of weak protein-protein and protein-excipient interactions. We discuss applications to protein formulation optimisation, de-risking mAb co-formulations, candidate developability assessments as well as residue-level structural details that can guide protein design.

14:50 Developability Assessment of Biologics and Formulation of Novel Molecules

Uddin_ShahidShahid Uddin, PhD, Director Drug Product, Formulation & Stability, Immunocore

 

 

Halo-Labs15:20 Fast, Low Volume Subvisible Particle Analysis with HORIZON

Mercado_GabrielGabriel Mercado, Senior Marketing Applications Scientist, Marketing, Halo Labs

Halo Labs knows particles. The HORIZON, our flagship product, detects, counts and characterizes subvisible particles.  A simple, plate-based approach enables low-volume (25 µL), high-throughput (96 samples) particle imaging and analysis at any stage of the biologics workflow from developability assessment through formulation and quality control.   

15:35 Sponsored Presentation (Opportunity Available)

15:50 Refreshment Break in the Exhibit Hall with Poster Viewing


16:25 KEYNOTE PRESENTATION: Comparative Evaluation of Chelating Agents to Prevent Polysorbate and API Degradation in Biologic Formulations

Riccardo Torosantucci, PhD, Section Head, Formulation and Process Development, Sanofi-Aventis

EDTA and other chelators are used in several products, few of which are biologics. Their needs, pros and cons as excipients are however still poorly understood. In this case study a head-to-head comparison of EDTA with other chelating agents is presented, including recommendations for their correct use in the formulation of protein-based therapeutics.

16:55 3D Printed Delivery Systems for Drugs and Biologics

Lamprou_DimitriosDimitrios Lamprou, PhD, Reader in Pharmaceutical Engineering, Queen’s University Belfast

Progress in drug design has led to the development of new peptides, proteins, and drug molecules. However, the limited ability to selectively deliver these molecules at well-defined dosing regimens remains a significant challenge. These challenges can be bypassed by using novel technologies such as 3D Printing/Bioprinting. Various designs with high drug payloads that formulated by 3D printing and characterised using advanced characterisation techniques (e.g., μCT, ToF-SIMS) will be discussed.

17:15 Biopharmaceutical Product Differentiation through Innovative Formulation

Jezek_JanJan Jezek, CSO, Arecor

With growing competition in the market and patient-centric product strategies, the demands for product differentiation are increasing. Innovative formulation together with appropriate device strategy is key in achieving such differentiation. This talk will demonstrate on several case studies how novel formulation principles can be used to develop products with superior stability with clear benefits for the patient, as well as leading to new patent applications extending the product exclusivity.

17:35 Antibody Formulation Using Bacterial Spore Derived Excipients

Batalha_IrisÍris Luz Batalha, PhD, Research Associate, University of Cambridge

Dipicolinic acid (DPA) is a small organic molecule that comprises 10-15% of the dry weight of spores and is involved in spore stability and resistance to wet heat. The application of DPA as a pharmaceutical excipient is somewhat hampered by its low aqueous solubility. Through counterion screening studies, we discovered two novel salts of DPA, ethanolamine-DPA and diethanolamine-DPA, which showed improved solubility and significantly reduced the viscosity of high concentration mAb formulations.

17:55 End of Day

18:00 Dinner Short Course Registration


Recommended Dinner Short Course*

18:30 - 21:00 SC7: Predicting & Controlling Bioformulation Stability

Instructors: Kevin Mattison, PhD, Principal Scientist, Malvern Panalytical

Matthew Brown, PhD, Applications Manager – AMEC, Malvern Panalytical

*Separate registration required.

Thursday, 26 March

8:00 Registration and Morning Coffee

PROTEIN AGGREGATION

8:25 Chairperson’s Remarks

Paul Matejtschuk, PhD, Section Head Standardisation Science, NIBSC (National Institute for Biological Standards & Control)

8:30 Protein Aggregation and Particulate Matters in Biologics

Paul_RajRajsekhar Paul, PhD, Fellow, Drug Product Development, Novartis

Formation of protein aggregates and other particulate matters in biopharmaceutical formulation are critical quality attributes of biopharmaceutical drug products. Aggregation propensity of biologics molecules affects stability of solutions and formulations. Protein particulates can form in a wide range of sizes and shapes. This talk will highlight the major issues due to insoluble aggregate and particulate matter formation during biologics development.

9:00 Chemical and Physical Protein Attributes that Influence the Self-Assembly of Proteins

McManus_JenniferJennifer McManus, PhD, Head of Department, Chemistry, Maynooth University

The self-assembly and aggregation of proteins during production and storage can produce assemblies with sizes ranging from nanometres to micrometres. I will discuss how the physio-chemical characteristics of a protein can influence formulation stability and will discuss the challenges associated with development and analysis of high concentration formulations.

9:30 Aggregation of Biologics in Liquid and Freeze-Dried State – Formulation and Processing

Matejtschuk_PaulPaul Matejtschuk, PhD, Section Head Standardisation Science, NIBSC (National Institute for Biological Standards & Control)

Biologics are labile molecules and are prone to aggregation. I will review our experience with model biologics, comparing the impacts of formulation and process on aggregate levels. Freeze drying can mitigate aggregation by delivering a stable format for long term storage and optimisation in terms of excipients used and freeze-drying cycle design will be presented. The value of Design of Experiments and high-throughput screening in optimising formulation will be described.

10:00 Sponsored Presentation (Opportunity Available)

10:30 Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing.

11:15 Towards an Improved Understanding of Aggregation: Interactions between Partially Folded Proteins Formed under Chemically Denaturing Conditions

Curtis_RobinRobin Curtis, PhD, Senior Lecturer, Chemical Engineering and Analytical Science, Manchester University

A key stumbling block towards predicting and controlling aggregation is isolating properties of partially folded or unfolded intermediates in the pathways. Here, we present a few examples, covering monoclonal antibodies and antibody fragments, where we have measured the association behaviour of unfolded intermediates using chemically denaturing conditions. The results provide insight into key structural properties controlling aggregation propensity and how excipients alter different steps in the aggregation pathways.

ADVANCES IN STABILITY AND DEGRADATION TESTING

11:45 How to Define a Stability Strategy for Adenoviral Vectored Vaccines

Binai_NadineNadine Binai, PhD, Scientist Product Characterization, Janssen Vaccines

Adenoviral vectors used in vaccine development are challenging study objects due to their complex composition of viral proteins as well as viral and transgene DNA. Determining routes of degradation is part of the stability strategy. Stability studies performed based on ICH guidelines in development are indented to define the shelf life. By additionally applying characterization methods to aged or stressed samples the route of degradation can be studied in more detail.

12:15 Advances in Stability and Degradation Testing to Demonstrate Physicochemical Similarity of Originator and Biosimilar Products

Arvinte_TudorTudor Arvinte, PhD, CEO, Therapeomic; Professor of Biopharmaceutics, University of Geneva

The talk will document the importance of using different orthogonal analytical methods to assess the similarity of originator products and biosimilar drug candidates. Case statues will include development projects and products such as bevacizumab and pegfilgrastim.

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

13:30 Session Break

13:45 Chairperson’s Remarks

Zahir Akhunzada, PhD, Research Scientist, Drug Product Science Development, Bristol-Myers Squibb

13:50 Stability Challenges and Control of Product for Oxidation Sensitive mAb

Vinther_Heydenreich_AnnetteAnnette Vinther Heydenreich, PhD, Senior Scientist, Symphogen

Batch variation can be a major problem for drug product stability and early knowledge of critical quality attributes (CQAs) and degradation mechanism can be essential to reduce/avoid challenges related to Chemistry, Manufacturing and Controls (CMC) processes at a later stage. In the current case study, it is highlighted how oxidation can affect product stability, and thus product quality for a complex product containing six different monoclonal antibodies.

ANALYSIS OF IMPURITIES, SUB-VISIBLE AND VISIBLE PARTICLES

14:20 Characterisation of Subvisible Particles: Old Challenges and New Improvements

Rios_Quiroz_AAnacelia Ríos Quiroz, PhD, Scientist, Group Leader Particle Lab, Pharma Technical Development Europe, Roche

The talk will give an overview on commercially available counting methodologies for detection of subvisible particles. This species, ubiquitously present in protein formulations, had been in focus due to immunogenicity and quality attributes of biotechnological products. Thus, the analytical toolbox to characterize them undergoes constant renewals and innovations. Their applicability towards the assessment of a meaningful array for particle counting characterisation will be discussed including examples of their use in the frame of immunogenicity studies.

14:50 Challenges in Analyzing High Concentration Proteins: Aggregates Characterisation of SVPs with MFI/FlowCam

Zahir Akhunzada, PhD, Research Scientist, Drug Product Science Development, Bristol-Myers Squibb
Analysis of protein biopharmaceuticals with high concentrations pose a number of challenges. Dipole-dipole interactions due to molecular crowding in high concentration biologics lead to self-association with increase in viscosity and changes in fluid dynamics. The presence of sub-visible particles (SVPs) is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring the formulation stability. The current compendial method based on light obscuration (LO) has limitations in analyzing translucent particles, and therefore demands the need for an unambiguous method to characterize SVPs. This presentation will discuss how to characterize and distinguish, both potentially proteinaceous and non-proteinaceous SVPs in protein formulations by using Microflow Imaging (MFI) in conjunction with the MIA (MFI Image Analysis) (Bio-techne USA), FlowCam and Lumetics software (Lumetics LINK, Canada).

15:20 Close of Summit

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