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DRUG FORMULATION DEVELOPMENT

Concentration and complexity: how formulation is the lynchpin for biologic development

by cyb2025
W. McDowell, G. Watts
antibodies
biologics
bispecific
Conjugates
formulation
intravenous
stability
subcutaneous
viscosity

Bill McDowell heads up the Abzena Cambridge Analytics group overseeing the group’s protein characterization, developability and formulation development activities. He has over 20 years’ experience of early-stage drug development in pharmaceutical R&D at GSK, supporting programmes targeting malaria, tuberculosis, AIDS, influenza, RSV, hepatitis C, Complement and other anti-inflammatory targets. Prior to GSK, Bill had 11 years in post-doctoral research in Germany and the MRC in London. His background is in protein biochemistry particularly protein glycosylation and mass spectrometry.
Bill joined Abzena in 2014 as a Team Leader in Bioconjugation and Analytical Chemistry and has been in his present role since 2017 being promoted to senior director in 2022.

Gary is the Director of Formulation Development at Abzena and is currently leading the pre-formulation and formulation development services. Gary is an expert in formulation and has a wealth of experience partnering with clients to establish optimal formulations for the required administration route, including very high-concentration products. He has worked with peptides, antibodies, vaccines, antibody-drug conjugates (ADCs), and novel antibody formats such as fusion proteins and multi-specific antibodies. He is also a co-inventor on two formulation patents. Gary has over 10 years’ experience in formulation and analysis of Biologics. Prior to joining Abzena, Gary worked at Arecor Ltd., leading formulation studies covering early-stage and late-stage development. He set up the R&D department and supported many programs treating diabetes, Duchenne muscular dystrophy, scleroderma, influenza, and various autoimmune diseases. 

ABSTRACT

The development of biologics, like monoclonal antibodies (mAbs), Antibody-drug conjugates (ADCs) and bispecific antibodies, has provided treatment for diseases once deemed untreatable, such as advanced cancers and autoimmune disorders. As powerful as these biologics are, their development still come with substantial technical challenges.
Behind every biologic drug is a formulation that ensures the molecule’s stability, safety and efficacy. This unassuming yet critical component must handle the inherent complexity of biologics and their sensitivity to environmental factors like pH and temperature, while maintaining efficacy and manufacturability at scale. Increasingly, formulation efforts also address a key patient-centric need: transitioning therapies from intravenous (IV) to subcutaneous (SC) formats. High-concentration formulations are central to SC delivery, but they introduce new technical hurdles that demand a great deal of expertise.

Challenges in biologic drug formulation

 

Physicochemical complexities
Biologics are inherently sensitive to their environment due to their large, complex molecular structures. Changes in temperature, pH and mechanical agitation can destabilize these molecules, leading to aggregation, degradation or precipitation. These issues can cause irreversible damage to the product with a subsequent loss of therapeutic efficacy or inducing adverse effects in patients.

Aggregation remains one of the most common challenges in biologic formulation. Aggregation not only reduces the potency of the biologic but also poses a significant risk of triggering adverse immune reactions. These aggregates often form due to weak intermolecular forces that become pronounced during storage or under stress conditions such as agitation during transport or freeze-thaw cycles.

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