MIBio - Stability of Biopharmaceuticals

19th October 2022 - Cambridge, UK.

by Harriet Thomasson, Senior Consultant
at Scendea

Introduction

Scendea were delighted to attend the 10th annual MIBio conference, which brought together experts in the field of biologics formulations. Since the development of mRNA vaccines during the COVID pandemic, significant advances have been made in formulation approaches to ensure the stability, safety, and efficacy of novel products.

Morning Session.

The morning session focussed on innovative formulation approaches to address challenges in ongoing development programmes. The session started with an overview of the pharmaceutical development of biologics in the past, present and future, and noted the increased flexibility shown by regulatory authorities towards novel formulation approaches for monoclonal antibodies, as seen in the 2022 revisions to ICH Q9.

Detailed case studies of formulation challenges followed, with an excellent lecture on approaches to low dosing and stability for highly potent novel biologics. As next generation biotherapeutics are engineered with a focus on biological activity, often at the expense of physical, chemical, and colloidal stability, formulation development must be optimised to confer stability in storage and maintain ease of administration to patients. The impact of seemingly minor changes to an established manufacturing process was highlighted in a fascinating case study from the manufacturers of a mAb, following the root cause analysis on out of specification results for visible and subvisible particle testing following a change in drug product filling apparatus.

An additional talk on the development of artificial cells provided insight into this novel approach to defining size, content and compartmentalisation of cell models. Details were shared on their various uses, including demonstrations of their use as in vitro models, targeted drug delivery systems, and vessels for synthesis of biologically active molecules.

Afternoon Session.

The afternoon session covered innovations in lipid nanoparticle formulations, and included a discussion panel on the ongoing changes to the product development and regulatory landscape post-COVID.

Material and product considerations for the manufacture of lipid nanoparticles were discussed in detail, with a helpful comparison of novel methodologies provided, including microfluidics. The use of lipid nanoparticles to accelerate patient access to cell therapies was also examined, wherein LNPs offer an option for non-viral delivery of CAR-T therapies. Screening and development of lipid nanoparticle libraries will be key to enable easy future use of this technology.

The discussion panel on changes to the product development arising from the COVID pandemic featured Scendea’s James Parsley, who provided his expert insight from a regulatory perspective. Changes in the approach of regulatory authorities to review of novel products was discussed, with key recent experiences being shared with the conference attendees.

The conference closed with a session on the challenges associated with cell and gene therapy product development, emphasising the critical role of CMC in progression of these products from proof of concept to regulatory approval. The importance of working closely with regulators was discussed, with examples of issues and their possible solutions presented.

Conclusion.

From the presentations given at MIBio 2022, it is clear that innovations in formulation development have been accelerated by the emergence of COVID-19 vaccines. These innovations, including the emergence of lipid nanoparticle formulations are now being leveraged in a wider range of biologics, expediting the delivery of novel biologics. With the continued collaboration of Academia, Industry, and Regulatory Authorities, formulation development is set to continue on this course, and play a key role in delivery of novel products to a broader patient population.

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