Newsletter | March 24, 2026

03.24.26 -- From Biology Grad To Manufacturing Guru

FOCUS ON OUTSOURCING

From Biology Grad To Manufacturing Guru

Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.

Charting A Successful CMC Journey For Your ADC Drug Product

These real-world case studies highlight best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in the clinical or commercial phase.

Navigating The New USP Chapter <382> For Elastomeric Closures

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

Solving Four Challenges In Development With Scale-Out Manufacturing

Scale-out biomanufacturing enhances flexibility, speeds timelines, lowers risk, and enables efficient parallel production for scalable, resilient biologics and advanced therapies.

Human Performance In Pharma: Strengthening The Biotech Workforce

Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

Utilizing Multiplex ddPCR To Streamline Viral Gene Therapy Workflows

Analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for better sensitivity, accuracy, and precision in therapeutic development.

Construct Viability: A Hidden Challenge In Viral Vector Manufacturing

Rapid, low‑cost checks can catch construct issues that limit vector manufacturing, enabling early fixes to improve titers, avoid delays, and accelerate gene therapy programs.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

Discover a disposable pen for Liraglutide 3.0 mg that demonstrates comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.

Strategies For Robust Process Characterization And Validation

Uncover how data-driven process design and effective technology transfer can accelerate validation readiness and help move biologics from development to commercial success faster.

Beyond Geographies — Derisking Global Manufacturing

Gain expert insights on mitigating risks in global pharmaceutical manufacturing by learning from Joon Chang and Tracey Partington’s decades of industry experience.

Microbial Manufacturing Platform For Non-Platform Proteins

Examine how innovative technology can revolutionize your recombinant protein manufacturing processes and enhance efficiency.

OUTSOURCING SOLUTIONS

Integrated ADC Offering: From Concept To Commercialization - Lonza

From Concept To Market: Mammalian Protein Development And Manufacturing - Avid Bioservices

Excellence In Every Injection. - Pfizer CentreOne

Opening New Frontiers In Genomic Medicine - ElevateBio

Freedom-To-Operate Gene Editing - Applied StemCell

Connect With Bioprocess Online: