Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.

Pharmaceutical Outsourcing Present and Future

The need for preclinical testing expertise is growing as molecular complexity increases.

Navigating the Preclinical CRO Outsourcing Process

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

A Closer Look at Affinity Ligands

Topic

Articles

Alcami Biologics formed to meet market demands for biological drug development services.

Alcami Announces Biologics Enterprise

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.

Catalent Invests in Zydis Ultra Commercialization

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

Fujifilm to Acquire Large-Scale Biologics Manufacturing Site from Biogen in $890-Million Deal

Joshua Zhang is head of WuXi STA’s Jinshan site.

Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.

Improving Process Mass Intensity for Bio/Pharmaceutical Production

Swedish based company, SenzaGen, has signed a license agreement with contract research organization (CRO) MB Research Labs.

SenzaGen Signs License Agreement with US-based CRO

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

Determination of Sodium Chloride in Yeast Extract by Ion Chromatography

Luke Deters is director Biologics at Catalent Pharma Solutions, Kansas City, Missouri, USA.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.


Quantification and Characterization of Polysorbate-80 in Protein Formulations

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

A monoplant may offer greater supply security and flexibility for specialist medicines.

Monoplant: Advantages of a Dedicated Facility

Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.

Handle with Care

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Ilene Roizman is communications manager at BioPlan Associates. 

Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.