Outsourcing

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.

CMO industry consolidation may be frustrated by a dearth of attractive assets.

Under the terms of the agreement, Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

Expansions at Catalent’s Kansas City, MO, and Madison, WI facilities made in response to industry demand.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

The testing laboratory will add capacity to strengthen its early-stage drug research capabilities for its small and large biotech clients.

Better process development is creating industry benchmarks for bioprocessing.

Biopharma and contract providers must tread carefully amid changing market dynamics.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

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Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

Despite emergence of biologics, small-molecule APIs benefit from industry growth.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.

  The European Medical Contract Manufacturing (EMCM) organization announced it will team up with VCC Medical NV for a unique personalized medicine initiative-the aseptic manufacture of a biologic therapeutic from the tissue of a patient’s tumor.

Focusing on niche and specialty service offerings gives contract biomanufacturing organizations an opportunity to differentiate in a crowded market.

When should CMOs and their pharma clients share the details of their partnerships with outside parties?

Suppliers indicate prices for single-use equipment are likely to increase.

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

Biopharma companies are outsourcing more jobs to cut costs.

Malvern Instruments' biophysical characterization equipment will be installed in a commercial applications laboratory in San Diego, California.

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.