Outsourcing

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.

The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

CDMOs can claim credit for the robust growth of emerging bio/pharma financings.

The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

A new report gives an overview of the work of the International API Inspection Program.