Viewpoint: No Clear Path for Pharma or Outsourcing
Politics, drug prices, tax reform, regulatory uncertainty leave CDMOs/CMOs guessing about pharma’s future.
Standards Set Excipient GMPs, But Collaboration is Needed
Meeting evolving global requirements for excipients requires close collaboration between pharmaceutical companies and excipient suppliers.
Mass Spectrometry Measures Up to Biologics Drug Analytical Challenges
Mass spectrometry plays and important role in advancing on biologic drug development and manufacturing, but limitations still exist.
Monitoring Supply Chain Risk on a Limited Budget
Monitoring supply-chain risk involves more than running a credit check on potential suppliers. It can, however, done without external expense.
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
PfizerCentreOne Expands Fill/Finish Services in Michigan
The company expanded fill/finish services at its facility in Kalamazoo, Michigan.
Metrohm USA Announces Winner of Young Chemist Award
Metrohm USA presented the Young Chemist Award to Aldin Malkoc for his work on cooperative, DNA-based molecular elements for electrochemical biosensors.
Novasep Opens New Bioconjugation Unit in France
The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.
Kemwell Announces Successful FDA Inspection at Bangalore Facility
The company announced that no Form 483 was observed at the company’s facility in Bangalore, India.
Abzena Signs Antibody Manufacturing Development Agreement with UCL
Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.
Recipharm Completes Kemwell Acquisition
Recipharm’s addition of Kemwell’s Bengaluru, India facility expands its solid- and liquid-dosage capabilities.
Sartorius and the European Molecular Biology Laboratory Collaborate on Training
Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.
SGS Adds to ICP-MS Capabilities
SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.
Catalent Completes Accucaps Acquisition
The acquisition complements Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.
FDA Warns India API Manufacturer Over Contamination Issues
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Quotient Clinical Expands US Operations
Quotient Clinical’s addition of CDMO QS Pharma increases the company’s footprint in the US an adds high potency molecule capability.
Drug Shortage Survey Points to Pharma’s Supply Chain Management Weaknesses
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
