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

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.

Articles

There are significant differences between small molecules and biologics fill/finish capacity.

Fill/Finish Capacity Use for Biologics

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

Cardinal Health to Build Facility to Manufacture Bayer Radioactive Therapeutic Agent

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

New England CRO/CMO Council Debuts

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Year in Review: Trends in Biopharma Manufacturing Outsourcing

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The Challenge of Finding the Unknown

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

Validation of a Multiplex Bead-Based Assay

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Rapid Screening for Elemental Impurities using ICP-MS

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.