11.06.25 -- The 9 Fastest-Growing Outsourcing Segments

Sterile manufacturing relies on three main contamination control strategies (CCSs): cleanrooms, RABS, and isolators. Understand how each system compares in sterility, cost, and flexibility.

As AI and adaptive trials redefine discovery speed, legacy CRO workflows create bottlenecks. Uncover how platform-driven systems restore alignment through automation and continuous improvement.

To guide your decision-making, we’ve outlined the top 10 criteria to consider when evaluating PDX models for your next oncology research or drug development program.

This Q&A discusses best practices for integrating program managers (PMs) into a sponsor company and how program managers help bridge the gaps between various stakeholders.

The development process for these products is complex, requiring careful consideration of regulatory requirements, technical feasibility, clinical efficacy, and patient-centered design.

Streamlining ADC development through a CDMO reduces risk, enhances quality, and accelerates timelines. Expertise in linker chemistry and bioconjugation also aids in overcoming ADC complexities.

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

A CDMO’s manufacturing science and technology (MSAT) plays a critical role in optimizing a biomanufacturing process to meet the needs of the modern healthcare landscape.

Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

In this case study, the analytical development group was provided an ELISA titer method, and the method was redeveloped to operate by biolayer interferometry (BLI) using the ForteBio Octet RED96.

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Coordination between sites, harmonized tech transfers, a quality system, and synchronized team activities can streamline regulatory submissions and deliver high-quality commercial outcomes.

The 2023 revision of EU GMP Annex 1 resets the global standard for sterile manufacturing. Learn what’s changed and how PIC/S alignment extends these requirements to many non-EU markets.

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

Advanced analytical technologies offer critical insights into the structural characterization and quantitation of biotherapeutics, helping to move projects toward clinic and manufacturing on schedule.

Lonza’s bYlok technology is a true plug-and-play solution to bispecific antibody engineering – high product quality, simplified processes, unlocking the future.

Uncover how two facilities in Canada and the United States are providing a full suite of analytical services, including characterization, potency testing, stability studies, and bioassay development.

Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.