09.11.25 -- The 15% Tariff: A Modest Jolt Or Deeper Disruption?

Explore advancements that focus on high-DAR, multispecific designs, and novel payloads, while addressing challenges in manufacturability, scalability, regulatory acceptance, and commercial viability.

Any errors during the fill/finish stage can delay clinical trials or even prevent meeting funding milestones. Be sure to avoid these four common pitfalls when outsourcing your fill/finish project.

Compare random and semi-targeted integration strategies for stable cell line development, highlighting their impact on expression consistency, scalability, and regulatory considerations.

Review key considerations for bioprocessing facility design for plasma-derived medicinal products.

Biosafety testing ensures biologics' safety and quality but faces challenges like cost, time, and technical complexity. Proper planning and regulatory compliance are key to success.

This presentation addresses the critical need for high-throughput, reliable analytical development strategies to support expedited Investigational New Drug (IND) applications.

A thorough and adaptable analytical strategy is essential for navigating the complex mAb market. This approach boosts the likelihood of market approval and unlocks the full potential of these therapies.

Increase speed, reduce risk, and maintain quality by partnering with a CDMO that has a comprehensive program for moving from discovery to clinical batches of a new biologic.

Process characterization and validation is an important step in the product development journey. Explore a case study of a mAb from clinical to commercial phase under a highly compressed timeline.

Learn how the new ICH Q14 guidance and AQbD principles can transform analytical method development into a more efficient, robust, and regulatory-ready process.

Leverage the expertise and gain the benefit of three industry leaders collaborating seamlessly to take your ADC from DNA to aseptic fill in record time.

Services include cell line development, microbial strain development, research cell bank production, process development, process optimization using statistical DoE, technology transfer, and more.

Discover how end-to-end drug product capabilities support the full lifecycle of biologics, seamlessly integrated with an extensive drug substance network across diverse modalities.

Examine how a new high-speed aseptic filling line can help bring your product to market with speed and efficiency while ensuring safety and high product quality.

From initial design through manufacturing and delivery, our quality systems provide a high degree of assurance throughout the life cycle of the product.