Search results for " therapeutic"
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…
Article
Managing Biomanufacturing Capacity Expectations
…macy benefit manager to reimburse a drug, a change in raw material availability, availability of new therapeutic alternatives, or new regulatory legislation.
In a Nature Reviews Drug Discovery st…
Article
A Bright Future for the Plasma Fractionation Industry
Some of the examples given by Perreault were in the area of recombinant plasma proteins, disruptive technologies, and especially improved diagnosis of patients and better access to therapeutics. Perre…
Article
Q&As with Industry Leaders
…DNA Product Specialist, Cytiva
Using Mechanistic Modeling in Process Development for Advanced Therapeutics
Felicity Thomas, Pharmaceutical Technology Europe
Peter Guterstam, Pr…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic and research uses, antibody titers in mammalian cell culture have increased dramatically over the past 20 years. …
Article
Elucidating Biosimilars Characterization
NIBRT: Differences regarding the approval process for small molecules as compared to recombinant protein therapeutics are reflected in the complexity that must be considered when comparing small-molec…
Article
Bracing for a Future Wave of Advanced Therapies
Pricing pressure for innovative therapeutics remains a volatile situation in the US market but, by Hunt’s assessment, the CGT market is still in its early days and working through the business model. …
Article
Report from the 12th Plasma Product Biotechnology Forum
SAb Therapeutics has several projects in the pipeline, spanning from Phase 1 to Phase 3 across three indications. This first session at the PPB meeting also included two “next generation” presentation…
Article
Need solutions for large-scale production of mRNA-based molecules?
mRNA therapeutics offer precise and individualized therapy and avoid manufacturing issues associated with recombinant proteins. Compared with current therapeutics, mRNA production is more cost-effecti…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
…4:36 - Common regulatory milestones that can turn into stumbling blocks for companies developing new therapeutics
7:12 - Best practices to navigate the regulatory approval path
9:44 - The…