Search results for "FDA"
Article
Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
Ensuring the Biological Integrity of Raw Materials
(2,3)
Global regulations, including those from the United States Department of Agriculture, the European Medicines Agency, and the FDA’s Center for Biologics Evaluation and Research (CBER) set sta…
Article
Evaluating E&L Studies for Single-Use Systems
FDA, Code of Federal Regulations 21 Part 211.65 and §211.94.
3. BPOG, Standard Extractables Protocol for Biopharmaceutical Single Use Systems and Components, www.biophorum.com/.
4. D. …
Article
The Tide Stays High
…has been positive, with an expectation that the regulatory environment will be less restrictive and FDA will be approving more drugs more quickly. There have even been suggestions that a venture capi…
Article
Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
By Agnes Shanley
Choosing excipients and supplie…
Article
Make buffer preparation more time and cost efficient with inline conditioning
Simplify Buffer Preparation
The volume and number of buffers for a typical downstream process can be considerable.
Preparation of these buffers is a challenge that in-line conditioning can o…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
What progress has been made in process development for continuous manufacturing?
FDA has aggressively been encouraging drug license holders to modernize manufacturing processes; continuous manufac…
Article
Continuous Processing for the Production of Biopharmaceuticals
Both FDA and the European Medicines Agency (EMA) have changed their guidelines to reflect a change in the definition of a batch. Batch is now defined by the quantity of material rather than the mode o…
Article
Selecting a Comprehensive Bioburden Reduction Plan
FDA guidance documents, PDA TRs, and the peer-reviewed literature all provide descriptions of potential point-sources of contamination. Bioburden may be associated with personnel, incoming raw materia…
Article
Fluid Handling in Biopharma Facilities
…ent contamination, maintain a sterile environment, and the use of biocompatible materials that meet FDA standards.
Kaap (Parker domnick hunter): Leak prevention is key when working with fluids. Ut…