APIs and Excipients

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

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

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

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

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.

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.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

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

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

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.

Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

Porton will use biocatalyst technologies from Codexis to accelerate API development for clients.

The new platform is expected to speed up cell line development.

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.