Search results for " formulation"
Article
Overcoming Buffer Challenges With In-Line Conditioning
With IC, buffers of desired formulations are prepared from smallvolume single-component stock solutions at the time of need. Formulating buffers from single-component stock solutions eliminates the ne…
Article
Selecting a Comprehensive Bioburden Reduction Plan
For example, mammalian cell lines or formulation constituents may require routine monitoring for mycoplasma or viruses. Open process operations are more susceptible to contamination than are closed pr…
Article
Aseptic Processing: Keeping it Safe
Clean water requirements
The demand for high-quality water for aseptic processing is of paramount importance, as water is not only an ingredient in many aseptic formulations, but is also as a clea…
Article
Manufacturers Struggle with Breakthrough Drug Development
FDA has adopted an “all-hands-on-deck” approach to dealing with breakthroughs, assigning highly experienced reviewers to work closely with manufacturers to devise clinical programs and to clarify form…
Article
Virus-like Particles as Therapeutic Moieties of the Future
These allow quick analysis of VLP assembly for monitoring consistency in VLP formulations during production
and storage (23).
A 19F-nuclear magnetic resonance-based system for studying VL…
Article
Modeling the Degradation of mAb Therapeutics
…rocessing (during protein expression in cell culture), downstream processing (purification), product formulation, storage, and transport (6, 7).
Factors that affect mAb stability
Factors that…
Article
Will My Buffers Work When Using an Inline Conditioning System?
Compared with preparing one concentrate per buffer formulation, many different buffers can be prepared from the same stock solutions using Cytiva’s Inline Conditioning system.
With the Inline Co…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Conditions of growth, the type of expression system, the formulation of the final product, and packaging decisions also affect the essential character of the product.
Adam Elhofy, chief science of…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
…rotein expression, development of the culture process, and purification of the drug substance, while formulation includes selection of excipients for the final drug product. During process developmen…
Article
Biopharma Advances Demand Specialized Expertise
For example, changes in formulations may cause different leachable profiles requiring increasing emphasis on extractables/leachables techniques (i.e., high-resolution MS) to support characterization o…