Manufacturing

The presentation details the addition of triethylamine to the guideline on toxic solvents.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

With this new line, Bischof + Klein will double its extrusion capacities for its CleanFlex clean room films.

The company opened a facility in Spain dedicated to the production of meglumine.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.

Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.

The company was cited by FDA for violations of sterile processing GMPs.

With a healthy supply of biosimilars heading to the approval pipeline, will license holders turn to contract manufacturers for development and production?

Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.

TraceLink’s first Drug Supply, Safety and Traceability Report suggests that 19% of pharma companies, 11% of distributors, and 9% of dispensers still haven’t begun to address lot-level serialization requirements. Only 20% say their CMOs will be ready for the November 2017 deadline.

Pylote SA discusses its Pyclear Protection packaging innovation.

Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.

Advances in materials and equipment for pharmaceutical blister packaging protect quality and enhance shelf life.

Healthcare policies, R&D investments, and drug approvals will test bio/pharma.

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

The co-located Pharma EXPO and PACK EXPO International presented technologies to protect products and people.

Pharma Tech introduced a new high-speed bottling line to its facility in Union, MO.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

The company has manufactured double-digit number of batches on the new filling line, for use in early-stage clinical trials.

The two companies have entered into an agreement to provide Suzeken with access to AmerisourceBergen’s Cubixx inventory solution.

A pilot project, beginning in 2017, will support the development of biosimilars.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.