Trends in Downstream Bioprocessing
While the severity of capacity problems related to downstream processing appears to have eased, it continues to be a problem and chromatography columns are the most frequent culprits.
Identification and Quantification of Trace-Level Protein Impurities
A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
Report from Brazil
Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.
Regulatory Roundup
Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.
Gauging the Outlook of the Biologics Market
Mike Jenkins, general manager of Catalent Biologics discusses the evolving landscape of the biologics market and hurdles faced in the development and manufacture of these innovative products.
The Elements of Training
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Prefilter Features PES Nanofleece Material
Sartorius Stedim Biotech's Sartoguard NF prefilter series features a combination of high-performance PES and innovative nano-fleece technology.
Ion Exchange Chromatography Resins for High-Resolution Purification
Tosoh Bioscience's two ion exchange chromatography resins are designed for the high-resolution purification of proteins, peptides, and oligonucleotides.
EU Raises API Standards: A Curse in Disguise?
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Best Practices for Restricted Access Barrier Systems
Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.
Outsourcing Partnerships for CMC Development
Are strategic partnerships in clinical research a model for CMC services?
Single-Use Systems Offer Lab-to Pilot-Scale TFF Operations
Novasep's Sius single-use tangential flow filtration skid offers a 100% single-use TFF solution.
FDA Works to Secure Drug Supply Chain
New FDA supply chain policies aim to strengthen inspection and oversight processes.
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Elucidating Biosimilars Characterization
Review the importance of characterization studies during biosimilars development and related analytical methods.
Connecting People, Science, and Regulation
PDA/FDA regulatory conference promotes a commitment to quality.
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
BioPharm International, September 2013 Issue (PDF)
Click the title above to open the BioPharm International September 2013 issue in an interactive PDF format.
BioPharm International, September 2012 Issue (PDF)
Trends in BioPharma
