BioPharm International
September 01, 2013
Separation and Purification
26
9
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.
September 01, 2013
Separation and Purification
26
9
A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
September 01, 2013
Global Reports
26
9
Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.
September 01, 2013
Regulatory Beat
26
9
Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.
September 01, 2013
Special Section
26
9
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.
September 01, 2013
Inside Standards
26
9
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
September 01, 2013
Separation and Purification
26
9
Sartorius Stedim Biotech's Sartoguard NF prefilter series features a combination of high-performance PES and innovative nano-fleece technology.
September 01, 2013
Separation and Purification
26
9
Tosoh Bioscience's two ion exchange chromatography resins are designed for the high-resolution purification of proteins, peptides, and oligonucleotides.
September 01, 2013
Regulatory Beat
26
9
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
September 01, 2013
26
9
Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.
September 01, 2013
Perspectives on Outsourcing
26
9
Are strategic partnerships in clinical research a model for CMC services?
September 01, 2013
Separation and Purification
26
9
Novasep's Sius single-use tangential flow filtration skid offers a 100% single-use TFF solution.
September 01, 2013
Regulatory Beat
26
9
New FDA supply chain policies aim to strengthen inspection and oversight processes.
September 01, 2013
Special Section
26
9
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
September 01, 2013
Special Section
26
9
Review the importance of characterization studies during biosimilars development and related analytical methods.
September 01, 2013
Guest Editorial
26
9
PDA/FDA regulatory conference promotes a commitment to quality.
September 01, 2013
Analytical Best Practices
26
9
Knowledge of product or process acceptance criterion is crucial in design space.
September 01, 2013
Issue PDF
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Click the title above to open the BioPharm International September 2013 issue in an interactive PDF format.