Newsletter | May 2, 2021

05.02.21 -- Biologics Outsourcing & Manufacturing Update

 
From The Editor

Did The U.S. Government Hijack A CDMO?

There are extenuating circumstances, but we need a deeper contemplation of what has gone on at Emergent BioSolutions regarding vaccine production. Outsourced Pharma readers are the experienced professionals to do that. So from that lens of supply-chain understanding, what’s happening here?

Advice For Cell-Therapy Biopharma: Strategic Building, Tactical Outsourcing

Knut Niss, Chief Technology Officer, Mustang Bio, Inc., has advice for all cell and gene developers: Build capacity now, outsource as needed later. Perhaps this changes when more CDMOs are set up to serve emerging biopharma. Here's a look.

Advice For Emerging Biopharma: No Stiff-Arming Your CDMO

“With regard to the ongoing nature of a relationship with a CDMO, you need to find a partner that can align with your ambition,” says Max Donley, Aurinia Pharmaceuticals. "However," he adds, when a positive drug-sponsor/CDMO relationship starts to deteriorate, "it’s often because the CDMO gets stiff-armed.”

Industry Insights
A Strategy To Remove Formulation Development From The Critical Path During Biologics Development

As a product development program progresses to Phase 3 clinical, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. This Q&A discusses the utilization of automation during formulation development.

Growing Your Biopharma: 10 Questions You’re Likely To Face From Investors — And How To Respond

One of the most important considerations in building your new drug program is funding to get you to your next milestone. In this guide, investment veterans and biopharma executives were asked which questions they often ask — and have been asked.

Regulatory Considerations For Biotech Startups

The whirlwind of activity emerging biopharma leaders are seeing for the first time isn’t entirely uncharted territory. Several startup veterans share insight and inspiration on clinical-stage regulatory considerations.

Shorten Time To Market With New Data-Driven Lyophilization Process

The use of computational fluid dynamics (CFD) for modeling development, advanced analytics, and state-of-the-art GMP lyophilization equipment enables better understanding of the process and reduces the time required for optimization of robust, scalable lyophilization processes.

Is Your Biologic At Risk For Protein Aggregation?

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.