Cambridge Healthtech Institute 第11回

Optimizing Biologics Formulation Development
( 生物製剤処方開発の最適化 )

Exploring the Future of Tools and Techniques for Formulating Novel Biologic Drug Products




Final Agenda


4:00 - 6:00 pm Pre-Conference Registration


7:00 am Registration and Morning Coffee


9:00 Welcome by Conference Organizer

Kent Simmons, Senior Conference Director, Cambridge Healthtech Institute

9:05 Chairperson’s Opening Remarks

Zhenyu Gu, PhD, Development Scientist, Global Analytical and Pharmaceutical Development, Alexion Pharmaceuticals


9:10 How Next-Generation Biotherapeutics Will Influence Formulation and Device Development

Kerstin Walke, PhD, Head, Pharmaceutical Development Biologicals, Boehringer Ingelheim

Patient self-administration is now expanding and the threshold limits for high concentrated formulations are driving development of high-volume delivery devices. Co-formulations of multiple monoclonal antibodies into a single drug product also offer patient convenience but drives the need for new analytical methods. There is also a trend toward advanced therapy medicinal products (ATMPs), a challenging new area for pharmaceutical development. This presentation will explore the impact of these trends on the formulation function.

9:50 Progress and Remaining Challenges in Formulating High Concentration Proteins for Patient Administration

Zhenyu Gu, PhD, Development Scientist, Global Analytical and Pharmaceutical Development, Alexion Pharmaceuticals

High-concentration protein formulation poses considerable challenges to the formulation and assay development. Manufacturing aspects including concentratability, viscosity and stability need to be considered in the early development. In this presentation, practical challenges and solutions to the molecule selection, formulation and analysis will be discussed for the formulation development of high protein concentrations.

10:20 Networking Coffee Break


10:45 Quality by Design and Design Control for Combination Product Development: Crossroads of Design Control and Manufacturing Risk Assessment

Leigh Bohack, PhD, Formulation Scientist, Pfizer

By developing an assembly, labeling and packaging (ALP) process Failure Mode and Effect Analysis (pFMEA), the fulfillment of user, product and regulatory requirements can be traced through the ALP process and identified risks can be mitigated. Utilizing engineering, PQ and PV manufacturing data is essential for building an understanding of this process and the impact to the combination product. This process generates a well-controlled process and quality product.

11:15 Analytical Strategies for Co-Formulated Products

George Svitel, PhD, Principal Scientist, Merck

Co-formulating multiple mAbs into a single drug product brings benefits including combined therapeutic effect, streamlined manufacturing/distribution and elevated patient convenience. But co-formulated products also bring additional product characterization challenges. Analytical methods originally developed for individual products need to be further developed for co-formulated products. There are also questions regarding mechanisms of degradation, aggregation pathways and possibility of creation of mixed aggregated species in co-formulated products.

11:45 Peptide Mixtures: Biophysical Characterization of Self-Association and Hetero-Oligomers

Marie Østergaard Pedersen, PhD, Specialist, Protein & Peptide Biophysics, Novo Nordisk, Denmark

Many peptides are prone to form oligomers with size and distribution depending on sequence, chemical modifications and formulation conditions. For mixtures of two different peptides, hetero-oligomer formation has the potential to alter stability properties and/or change pharmacokinetic profiles. Thus, a thorough biophysical understanding of each individual component, and their interactions, is required. This talk will present an overview of biophysical techniques relevant to the study of peptide mixtures.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Session Break

12:55 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own


2:00 Chairperson’s Remarks

Brian Lobo, PhD, Associate Director, Formulation Development, MedImmune

2:05 Exploring the Determinants of Viscosity and Self-Association in Highly Concentrated Antibody Solutions Using Molecular Dynamics

Benjamin Walters, PhD, Scientist, Technology, Genentech

Using a novel physics-based multi-scale coarse-grained approach, we explore how high viscosity can emerge from weak self-interactions. Key developments that enabled this work are discussed, including our novel strategies to preserve electrostatic fields and hydrophobicity features. Our method improves on currently available approaches, evidenced by comparison against a large dataset, and facilitates formulation development activities, such as considering the effects of salt, without consumption of material.

2:35 Protein-Protein Interactions and Relevance to Viscosity

William Callahan, MSc, Senior Scientist, Process Development, Amgen

Protein viscosity is known to be correlated with protein-protein interactions. Using a solubility parameter approach, we show that common properties of water miscible solvents are involved in the degree to which protein-protein interactions occur as measured by differences in viscosity. These short-range interactions are related to the dispersion energy, polar energy and hydrogen bonding energy of test solvents. It can also be shown that the viscosity can be reasonably predicted through correlation with surface tension measurements of these solvents.

3:05 Find Your Table and Meet Your BuzZ Session Moderator

3:15 BuzZ Sessions with Refreshments

Join your peers and colleagues for interactive roundtable discussions.



4:30 Miniaturized High Throughput Screening for Formulation Development

David Smithson, PhD, Scientist, Genentech

For the last four years our group has worked to develop miniaturized model systems suitable for formulation development efforts of biologics across our portfolio. These efforts have been focused in two distinct areas – physical miniaturization of our stability workflow and evaluation of improved high throughput amenable biophysical techniques for characterization of formulation candidates. We will present the current status of these efforts and discuss applicability of these techniques at various project stages.

5:00 Formulation Development Challenges of Antibody Drug Conjugates

Brian Lobo, PhD, Associate Director, Formulation Development, MedImmune

Antibody drug conjugates (ADCs) combine the physical-chemical stabilities and functions of monoclonal antibodies with the chemical and structural attributes of small molecule cytotoxics. Case studies are presented that demonstrate the challenges to assure stability and container compatibility of the mAb intermediate, frozen and liquid stability of ADC drug substance, stability of the ADC to lyophilization, and clinical compatibility of the ADC at very low doses for i.v. administration.

5:30 Formulation and Delivery Challenges for AAV Gene Therapy Products

Roberto DePaz, PhD, Associate Director, Formulation & Drug Product Development, RegenxBio

There is a growing pipeline of investigational gene therapy products using adeno-associated virus (AAV) vectors, boosted by encouraging clinical results and recent commercial approvals. A successful gene therapy product formulation must be stable during production, storage, and distribution, while meeting the dosage needs for the intended route of administration. This presentation will highlight some of the challenges encountered during the formulation development of these complex macromolecules.

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing

7:15 Close of Day


8:00 am Registration and Morning Coffee


8:30 Chairperson’s Remarks

Jun Zhang, PhD, Senior Scientist, Preformulation, AbbVie

8:35 Antibody Design to Improve Physical Stability

Christopher J. Roberts, PhD, Professor, Chemical & Biomolecular Engineering, University of Delaware

This presentation will focus on a series of coarse-grained molecular models and comparison to experimental data for predicting how changes in surface-charge distributions and formulation conditions can be used to predict protein-protein interactions and how these influence the physical stability of antibodies at low to high concentrations. Pros and cons of different modeling scales will be highlighted.

9:05 Matching pH Values for Antibody Stabilization and Crystallization Suggest Rationale for Accelerated Development of Biological Drugs

Hanno Sjuts, PhD, Postdoctoral Researcher, Protein Crystallization, Pharmaceutical Development Biologics, Sanofi, Germany

It is well known that the pH has critical influences on both a protein’s colloidal stability and it’s crystallization behavior. Here, differential scanning fluorimetry was used to determine pH values that exert highest thermal stabilities for three mAbs. Interestingly, the same pH values are required for successful crystallization of the respective mAbs. The results suggest strategies for how crystallography could be integrated into the development of novel biotherapeutic drugs for accelerated approval times.

9:35 Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing


11:00 Toward Improved Candidate Selection and Formulation Development: Understanding Tangential Flow Filtration Instability of Proteins

Yuan Cheng, PhD, Senior Research Investigator, Discovery Pharmaceutics & Analytical Sciences, Bristol-Myers Squibb

Tangential flow filtration (TFF) is one of the common unit operations in biologics manufacturing. Some proteins are found to be sensitive to the stresses imposed during TFF process, leading to aggregate and particulate formation, which can cause significant delay in the development timeline. This talk focuses on introducing our efforts on building mechanistic understanding of TFF instability of proteins and developing predictive assays to help risk assessment in candidate selection and formulation development.

11:30 Biophysical Characterization of Therapeutic Antibody Non-Specific Binding for Drug Candidate Selection and Developability Screening

Jun Zhang, PhD, Senior Scientist, Preformulation, AbbVie

Understanding mAb properties that affect non-specific binding in vivo are important for sequence engineering and pharmacokinetic optimization. Both hydrophobicity and electrostatic mAb properties play important roles in non-specific binding in vivo. We show that heparin binding and FcRn affinity chromatography complement hydrophobicity assessment by HIC and that incorporating these methods into molecular profiling regimens provides insight into biodistribution in addition to stability during candidate developability screening.

12:00 pm Presentation to be Announced

12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Close of Optimizing Biologics Formulation Development Conference

5:45 - 8:45 Recommended Dinner Short Courses*

SC3: Protein Aggregation: Mechanism, Characterization and Consequences

Click here for more details.

*Separate registration required

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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