Drug Development

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.

Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.

Choosing between presterilized and bulk sterilized prefilled syringes.

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.

The Thermo Scientific Pharma mini implant line is an integrated solution built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

Fluid Air’s PolarDry spray dryers use electrostatic technology, providing low-temperature spray drying, encapsulation, and selective agglomeration in the creation of particles.

Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.

EMA and FDA guidance encourages design of drug products to improve patient compliance.

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.