Outsourcing

Why shouldn’t biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market?

Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.

Quartzy, an online laboratory supply management company, will offer lab products from Bioline, Biotium, and MP Biomedicals.

The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.

The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan.

The acquisition will place Cambrex into the finished dosage form CDMO market.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Catalent’s acquisition of Juniper Pharmaceuticals further expands its early development capabilities.

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.

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

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

Recipharm adds inhalation drug manufacturing capacity with the acquisition of Sanofi’s Holmes Chapel, UK site.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

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

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

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.

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

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

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

Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility.

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

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