Outsourcing

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.

Rommelag will showcase its single-use, flexible packaging system at Achema 2018.

Rommelag will showcase its blow-fill-seal technology that collectively offers container production, aseptic filling, and container closure.

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.

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

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

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.

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

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

Grand River Aseptic Manufacturing announces equipment purchase to add vial filling capacity.

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

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

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.