Pharmaceutical Technology Sourcing and Management Monthly Issue:
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Pharm Tech
March 2017
Volume 12 Issue 3
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In This Issue

In the Lab
APIs & Excipients
Outsourcing Update
Supply Chain Update
Contract Services Update


In the Lab

Mass Spectrometry Measures Up to Biologics Drug Analytical Challenges

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

Evaluating E&L Studies for Single-Use Systems

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

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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.
/ read more /

Sartorius and the European Molecular Biology Laboratory Collaborate on Training

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

SGS Adds to ICP-MS Capabilities

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


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APIs & Excipients

Standards Set Excipient GMPs, But Collaboration is Needed

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

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.
/ read more /


Outsourcing Update

Viewpoint: No Clear Path for Pharma or Outsourcing

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


Supply Chain Update

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, be done without external expense.
/ read more /

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.
/ read more /


Contract Services Update

Novasep Opens New Bioconjugation Unit in France

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

Catalent Completes Accucaps Acquisition

The acquisition complements Catalent's global OTC and prescription pharmaceutical softgel capabilities and capacity.
/ read more /

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.
/ read more /

PfizerCentreOne Expands Fill/Finish Services in Michigan

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

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.
/ read more /

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.
/ read more /

Recipharm Completes Kemwell Acquisition

Recipharm's addition of Kemwell's Bengaluru, India facility expands its solid- and liquid-dosage capabilities.
/ read more /


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