Manufacturing

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.

The investment doubles the company’s capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

Lupin acquires businesses in Germany, the US, Russia, Brazil, and South Africa.

Avista grows its contract services business, and Scynexis focuses on antifungal development.

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.