Pharmaceutical Technology-02-01-2019

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.

Pharmaceutical Technology spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development, validation, and sample analysis services, about best practices to ensure that biologics are safe and effective.

Pharmaceutical Technology spoke with Lisa Crandall, MS, associate director CMC Project Management, and Peter Angus, PhD, director of Pharmaceutical Sciences, at Velesco Pharma, which provides a full range of stability testing of API and drug products, about best practices in stability testing.

Suppliers set the tone for 2019 with strategic expansions, investments, and acquisitions.

A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.

Click the title above to open the Pharmaceutical Technology 2019 Partnering for Bio/Pharma Success in an interactive PDF format.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.