12.16.25 -- Considerations In Sterility Testing And Assurance

Learn how EAM and CMMS systems help pharma manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.

Uncover the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

See how evolving global regulations are reshaping CDMO strategy. and how digital infrastructure helps manufacturers stay audit-ready, build sponsor trust, and turn compliance into an advantage.

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.

Find out how automated immunoassays outperform ELISA in AAV quantitation—offering better sensitivity and precision to help you identify the best media for high viral titers.

Examine the ways to design and de-risk molecules, streamlining the path to GMP manufacturing and clinical trials, and case studies that provide insight into key activities.

Gain insight into a platform that optimizes high-concentration therapeutic antibody formulations, as well as overcomes stability and manufacturability challenges to deliver safe, effective therapies.

An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

Discover an Isothermal Titration Calorimetry tool that is precise for characterizing molecular interactions, which is crucial for drug discovery and lead optimization in pharmaceutical research.

Hear about strategies that improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

Pharmaceutical companies must prioritize patient-centric dosage forms to address challenges like dysphagia, enhance medication compliance, and improve therapeutic outcomes.

Review a family of medical-grade polyurethanes that are engineered for high performance, biocompatibility, and reliability in advanced, critical medical device applications.

Investigate the impact of peptone supplementation on adenovirus and VSV production, highlighting its potential to reduce serum dependency in cell culture media.