Manufacturing

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.

The agency is looking for industry input on best practices for continuous manufacturing.

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.

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.

Innovation speeds discovery, drives down costs, and improves productivity.

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

It’s time to stop talking about “anticounterfeiting,” and move to integrated, collaborative supply chain security, experts say.

Emerging anticounterfeiting technologies offer pharmaceutical manufacturers more options for supply chain security.

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

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.

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

Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.

Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

The International Society of Automation (ISA) and Siemens entered a global partnership to increase awareness of industrial cybersecurity needs and standards.

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000 ft.2 analytical laboratory.

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

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 agency published guidance on identifying trading partners under DSCSA.