PTSM: Pharmaceutical Technology Sourcing and Management-04-06-2016

Pharma’s traditionally conservative approach to supply-chain management may be hindering its ability to adapt to changes in demand.

Manufacturers and contract development and manufacturing organizations are developing processes and facilities to meet growing specialty API demand.

Determining the appropriate amount and type of screening challenges drug developers when identifying relevant crystalline forms.

Pharma companies must weigh cost efficiencies of global API sourcing with increased complexities of monitoring for compliance and quality.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

At DCAT's annual meeting, Bill Downey, president of the market research firm High Tech Business Decisions, summarized results from its latest survey on biopharmaceutical outsourcing.

The service center will act as a hub for delivery, maintenance, calibration, and technical support for the company.

A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.

With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

The investment includes facility upgrades and expansion of development capabilities.

The inspection confirmed that the facility was compliant with GMP guidelines.