Drug Development

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

Kancera’s drug candidate KAND567 will be developed as a capsule formulation for oral administration. Work will be performed at Recipharm’s development facility in Solna, Sweden.

Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering.

BARDA has awarded Summit, a drug discovery and development company, a contract worth up to $62 million over five years for the development of a new small-molecule antibiotic.

Scientists at Scripps’ Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Continuous twin-screw granulation offers several options for increasing production scale. Thermo Fisher Scientific explains factors to consider in scale-up projects for manufacturing oral solid-dosage drugs.

Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.

When it comes to getting the best out of quality by design, timing is everything.

Considerations in selecting a dosage form for drug delivery to the lungs.

Roquette has completed its previously announced acquisition of Itacel, an excipient division of Blanver.

Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how-with the right knowledge and expertise-these challenges can be overcome.

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing. 

The industry needs a single standard cleaning limit at 25 mg/m2.

MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex’s lead oncology antibody drug candidate to clinical use.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.

The private investment firm’s $110-million acquisition boosts its API and finished dosage form value chain.

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.