Drug Development

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

CordenPharma will expand development capacity for small molecules, peptides, and carbohydrates at its Liestal, Switzerland site

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Piramal is investing $55 million into the expansion of its API manufacturing capabilities and capacities across sites in North America and Asia.

Dow’s portfolio of solutions for pharmaceutical applications now includes products from Dow Corning’s silicone technology platform.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

West will be showcasing its range of packaging components and drug delivery solutions, including NovaPure components, LyoSeal caps, and the SmartDose platform.

Predicted areas of growth include flow chemistry, fermentation, repatriation of overseas funds, oncology, and API/product integration, but the rate of change is unclear.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

Investments include the installation of development and analytical equipment to support the development of highly potent APIs as well as a new 2800-liter hydrogenator and 1500-mm diameter centrifuge for increased flexibility and capacity within the manufacturing plant.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.

Europe updates the guideline on excipients information in labeling and packaging.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Compared to traditional drug discovery approaches, drug repurposing, repositioning, and rescue can be faster and cheaper.

Indena is completing the construction of a new GMP kilolab for highly potent APIs.

Virgin Atlantic Cargo and Delta Cargo have opened a new Pharma Zone at their joint facility at London Heathrow Airport for the handling and storage of pharmaceutical shipments.

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

A grant from the Bill & Melinda Gates Foundation will advance PnuVax’s pneumonia vaccine’s clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

The pharmaceutical industry is under tremendous pressure to make drug development faster and cheaper. Applying the right formulation strategy using structured and rigorous science can help avoid costly failures and re-starts, but it’s important to start from an early stage.