09.18.25 -- What If You Need Multiple CDMO Partnerships? (Discussing Resilience, Risks)

Manufacturing specialized formulations isn’t just about technology. Assessing a CMO's proficiency and adaptability with the latest technology will ensure seamless alignment with a product’s unique demands.

CDMOs play a critical role in TPD development by offering specialized infrastructure and analytical capabilities to support the transition from preclinical research to clinical supply and commercialization.

The process of technology transfer is structured and involves several key stages. Each stage guarantees a seamless transition from lab-scale to commercial production.

Antibody-drug conjugate innovators often question whether to outsource manufacturing activities or bring them in-house. Here, the author provides some key considerations.

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

In this presentation, industry-leading bioprocess experts explore the challenges and opportunities that arise when implementing Quality by Design (QbD) in biologics development and manufacturing.

Learn how AI is transforming the biomanufacturing industry and how partnerships between pharmaceutical companies and academic institutions are poised to set the new standard.

Examine advanced analytical solutions that detect, characterize, and mitigate particle formation in high-concentration biotherapeutics caused by protein aggregation and surfactant degradation.

Recognizing the increased complexity of biologic analyses, as compared to small molecule drugs, can help avoid unnecessary complications and prevent cost overruns.

Explore real examples of how this outsourcing partner helps drug sponsors through transparency that empowers, integration that simplifies, methods that de-risk, and experience that accelerates.

Review how bYlok® technology can drive correct heavy-light chain pairing to >95% and how you can access it via a license agreement to overcome industry-wide challenges in bispecific production.

Our new biologics manufacturing facility features GMP capabilities from 50L to 2000L — scaling to 5000L soon — with a DP filling line and ADC conjugation suite set to redefine bioproduction in India.

Beth DiPaolo, SVP, recounts how the company started with a client who needed a tailored service model to meet a scope of work they would never outsource, laying the foundation for a client-focused culture.