PTSM: Pharmaceutical Technology Sourcing and Management-09-06-2017

Matching the production requirements of a bio/pharma company with the manufacturing capabilities of a CMO is a delicate balance, requiring attitude shifts on both sides of the table.

Technology improvements in analytical testing tools have helped increase understanding of molecules and speed up development processes.

Media manufacturers improve processes and technologies to reduce risks and improve quality and consistency, while managing costs.

USP is developing new guidelines to help organizations prioritize risk and ensure raw material quality.

Lonza is expanding parenteral dosage development capability and capacity in its Drug Product Services (DPS) sector at the company’s Basel, Switzerland facility.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000 ft.2 analytical laboratory.

Thermo Fisher Scientific has completed the previously announced acquisition of Patheon for approximately $7.2 billion.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

The agency published guidance on identifying trading partners under DSCSA.

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

Charles River Labs has announced the acquisition of Brains On-Line (US), a contract research organization (CRO) that provides data on therapeutics for treating central nervous system (CNS) diseases.