Validation of Critical Process Input Parameters in the Production of Protein Pharmaceutical
Products: A Strategy for Validating New Processes or Revalidating Existing Processes | PDA …

Biopharmaceuticals are drugs, vaccines, and pharmaceutical agents (typically therapeutic
proteins or polypeptides) developed or produced using techniques of biotechnology [1]. In …

The approach for development and characterization of biopharmaceutical manufacturing
processes has been gradually changing since the introduction of Quality by Design (QbD) in …

BACKGROUND A goal in the production of biopharmaceuticals is to replace the cost‐
intensive, empirical 'quality by testing'approach with rational, knowledge‐based 'quality by …

This study describes the application of quality by design (QbD) principles to the
development and implementation of a major manufacturing process improvement for a …

The identification of critical process parameters in biologics and small molecule process
development is a key element of quality by design. The objectivity and consistency of …

Biotech‐based therapeutics have emerged as the growth engine for the pharmaceutical
industry. Successful development and commercialization of biotech processes require the …

Written by experienced authorities in process validation, Process Validation in
Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for …

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance,
while healthcare systems across the globe are looking to contain costs and improve …

The process analytical technology (PAT) initiative is now 10 years old. This has resulted in
the development of many tools and software packages dedicated to PAT application on …