Search results for " opportunity"
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Poster
Process economy and production capacity using single-use versus stainless steel fermentation equipment
The increased batch throughput also generates a greater profit opportunity, which benefits can outnumber the higher production cost per batch associated with the single-use alternative. With the decre…
Article
Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Antibodies and related proteins comprise one of the largest and fastest-growing classes of protein pharmaceuticals. A majority of such molecules are monoclonal antibodies; however, many new entities…
Article
The Metrics of Quality Culture
The guidance leaves the opportunity open to establish quality-culture metrics by stating, “these metrics are not intended to be an all-inclusive set of the quality metrics that FDA could consider usef…
Article
Selecting a Comprehensive Bioburden Reduction Plan
In these cases, the hold times are typically shorter, but there is less of an opportunity to reduce the temperature of intermediate product pools. As such, the approach that might be adopted for biobu…
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Biopharma Advances Demand Specialized Expertise
Those companies that are best able to successfully characterize and differentiate innovator and biosimilar products for safety and efficacy will have the greatest opportunity to benefit.
The knowle…
Article
Re-use of Protein A Resin: Fouling and Economics
Overall, the survey suggested that there may be opportunity for manufacturers to come up with more economical Protein A resins with extended lifetime.
Summary
The survey provides a detailed in…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
That said, in light of the manufacturing scale for single-use columns (generally clinical), we believe there is a market opportunity for a lower cost media where the highest level of performance is un…
Article
Biopharma Manufacturers Respond to Ebola Crisis
There has been broad interest in using tobacco and other plants to produce vaccines and biologics for multiple indications, and further testing of ZMapp provides an opportunity to evaluate biopharming…