Manufacturing

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.

Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.

As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.

Fujifilm has bought Biogen ApS’ Copenhagen facility for US$890 million.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

Researchers in China are playing a role in advancing gene therapy development.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

Olon began construction of a GMP facility for biologic APIs in Capua, Italy.

Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.

The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.

The freedom of design found in additive manufacturing offers the potential for improved processing equipment, both in prototypes and commercial equipment.

Teva harmonizes its generic drug packaging brands under its corporate umbrella with a redesign.

The Coalition for Epidemic Preparedness Innovations is partnering with Colorado State University to develop a single-dose vaccine candidate against Rift Valley Fever.

Development and manufacturing machine specialists, groninger, have opened a new showroom at its headquarters based in Crailsheim, Germany.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Lonza plans to implement MES software to accelerate paperless, 24/7 production of drug capsules.

Process Automation Solutions becomes the latest partner to join the TrendMiner ecosystem.

Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.