Outsourcing

Heightened global uncertainty could slow bio/pharma development activity.

Industry experts discuss what the outsourcing market holds for 2016.

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

The company plans to reformulate injectable products to make them into inhaled and intranasal medications.

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.