PTSM: Pharmaceutical Technology Sourcing and Management-03-01-2017

Politics, drug prices, tax reform, regulatory uncertainty leave CDMOs/CMOs guessing about pharma’s future.

Meeting evolving global requirements for excipients requires close collaboration between pharmaceutical companies and excipient suppliers.

Mass spectrometry plays and important role in advancing on biologic drug development and manufacturing, but limitations still exist.

Monitoring supply-chain risk involves more than running a credit check on potential suppliers. It can, however, done without external expense.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

The company expanded fill/finish services at its facility in Kalamazoo, Michigan.

Metrohm USA presented the Young Chemist Award to Aldin Malkoc for his work on cooperative, DNA-based molecular elements for electrochemical biosensors.

The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.

The company announced that no Form 483 was observed at the company’s facility in Bangalore, India.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

Recipharm’s addition of Kemwell’s Bengaluru, India facility expands its solid- and liquid-dosage capabilities.

Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.

SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.

The acquisition complements Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.

Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages