BioPharm International-10-01-2019

New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.

Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.

Climbing out of a reputation hole can start with adopting a quality culture.

Leveraging automation and a step-by-step approach are keys to success.

Falsified documents and manipulated test results prompt warnings and investigations.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.

BioPharm International spoke with Marybeth Reynoso, senior director, early development strategic operations at PPD about the direction the industry is taking regarding the outsourcing of early development operations to contract research organizations (CROs).

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