Manufacturing

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

GSK reports no employee injuries at the facility and is assessing damage.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

WuXi PharmaTech and TruTag Technologies successfully applied and detected TruTag's edible microtags on solid-dosage drug products and found no effect on dissolution.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

The reconfigured Sartobind membrane adsorber capsules from Sartorius Stedim Biotech is said to have higher binding capacities, reduced void volumes, as well as consume less buffer, enabling lower operational costs.

GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.

The Alpha agitator bead mill from Netzch is designed to mount different grinding systems on the same base platform.

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis steroid drug product.

Contract research, development, and manufacturing organizations (CROs, CDMOs and CMOs) are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

The agreement gives Merck a non-exclusive license to use Codexis’ proprietary CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck’s pharmaceutical products.

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

Paperless operations improve efficiency and increase assurance of product quality.

Choosing the correct shipping solutions, including packaging, transportation mode, and monitoring, helps mitigate the risks inherent in global logistics.

FDA and industry support global framework and collaborations to secure the supply chain.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

The Ross Inline Solids/Liquid Injection Manifold (SLIM) Mixer is designed to work with a range of powders that are challenging to mix into liquids.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.