Search results for "FDA" in Articles / App Notes
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…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
In addition to assessing factors and conditions for the optimization of the purification steps, the quality-by-design (QbD) initiative introduced by FDA requires a deeper understanding of critical pro…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
During an inspection conducted by FDA, it was observed that tanks used for the manufacture of a single API, carried out a few months before, were not cleaned since the last campaign. The interior of t…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
…ne a step further, and broadened the International Conference on Harmonization guidances adopted by FDA into “development by design” (DbD).
“We say, first consider the endpoint, then take process…