01.12.26 -- 7 Outsourcing Behaviors For 2026 That Will Protect Timelines

CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.

In developing a CDC assay for therapeutic mAb characterization or QC release testing, consideration should be given to the expression of CRPs on the cell surface.

In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.

How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

Delve into the complexities of scaling decisions to gain insights from biopharma developers and a CDMO. Learn about their mutual interest in achieving successful strategies for avoiding common pitfalls.

Biomanufacturing relies too heavily on trial and error. By integrating AI and mechanistic models into early design, developers can overcome productivity limits and accelerate timelines for complex modalities.

See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

A standardized, end-to-end, multi-plant biomanufacturing model enables faster timelines, flexibility, and consistent global quality, turning CDMO partnerships into a sustained competitive advantage.

Learn how to accelerate the journey of ADC candidates from early discovery to clinical development, enhancing the success rate of translating preclinical discoveries into effective cancer treatments.

With decades of experience, we offer a flexible and collaborative partnership model for manufacturing excellence that enables our clients to increase speed to market with full regulatory confidence.

With a foundation built on operational excellence, cutting-edge technology, and strategic capacity expansion, we’re equipped to overcome the most demanding manufacturing challenges.

Your partner in contract production and development using the end-to-end business model. We specialize in the production of sterile biotechnological products that meet GMP requirements.

Pedro Morales, Director, Scientific Advisor of Biologics Analytical Services, explores how Catalent delivers tailored solutions through deep expertise and advanced capabilities.

This system is a comprehensive toolbox for biologics development, enabling the creation of not only monoclonal antibodies but also a broad range of innovative molecular formats.