BioPharm International, September 2013 - BioPharm International

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BioPharm International, September 2013
Special Section
Elucidating Biosimilars Characterization
By Adeline Siew, PhD
Review the importance of characterization studies during biosimilars development and related analytical methods.
Gauging the Outlook of the Biologics Market
By Adeline Siew, PhD
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.
Biosimilars Development and Supply: How Complex Can the Process Be?
By Martin van Trieste
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Separation and Purification
Trends in Downstream Bioprocessing
By Eric Langer
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
By Hongxia (Jessica) Wang , Zhiqi Hao , Yi Zhang , David Horn , Patrick Bennett
A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.
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.
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.
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.
Regulatory Beat
FDA Works to Secure Drug Supply Chain
By Jill Wechsler
New FDA supply chain policies aim to strengthen inspection and oversight processes.
EU Raises API Standards: A Curse in Disguise?
By Sean Milmo
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Regulatory Roundup
By Jill Wechsler
Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.
Analytical Best Practices
Essentials in Establishing and Using Design Space
By Thomas A. Little, PhD
Knowledge of product or process acceptance criterion is crucial in design space.
Perspectives on Outsourcing
Outsourcing Partnerships for CMC Development
By Jim Miller
Are strategic partnerships in clinical research a model for CMC services?
Inside Standards
The Elements of Training
By Susan J. Schniepp
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Global Reports
Report from Brazil
By Hellen Berger
Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.
Guest Editorial
Connecting People, Science, and Regulation
By Richard Johnson
PDA/FDA regulatory conference promotes a commitment to quality.

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