Outsourcing

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Sharing of bioprocessing know-how can help resolve pressing industry problems.

Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs’ and CDMOs’ decisions to expand their biopharmaceutical services.

The acquisition strengthens Nelson Labs’ outsourced testing capabilities for the pharmaceutical and medical device industries.

The company is certified as a manufacturer of pressure vessels and components for use in China.

An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.

Pharmaceutical scientist association announces upcoming term’s board of directors.

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).

This article highlights 15 years of changes in biopharmaceutical manufacturing.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Madison Dearborn Partners will acquire a majority ownership position in CDMO Alcami.

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

New and expanded facilities point to the continuing growth of the biopharmaceutical industry.

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.