Manufacturing

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

The Gx Elite vials are the result of comprehensive optimization measures in the conversion process, which have focused on designing out the risk to create product flaws during production including the removal of all glass-to-glass contact beginning with the tubing material all the way through final packaging.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has launched its Delta-molded, type 1 glass vials in North America.

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.

Shingrix represents a new, possibly better alternative to existing treatments.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

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.