PTSM: Pharmaceutical Technology Sourcing and Management-08-03-2016

PTSM: Pharmaceutical Technology Sourcing and Management

NIST Issues mAb Reference Standard

July 28, 2016

In the Lab

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8

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

Saneca Pharma Secures Contract Manufacturing Agreement with Xantis Pharma

July 26, 2016

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8

CDMO Saneca Pharma has sold registration dossiers for more than 20 pharmaceutical products to Xantis Pharma and will hold an exclusive five-year contract manufacturing agreement for the products with Xantis Pharma.

EMA Suspends Drugs Due to Flawed Bioequivalence Studies

July 22, 2016

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8

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

CordenPharma Expands into Oligonucleotide APIs

July 22, 2016

Contract Services Update

11

8

The company will expand its service offerings to include oligonucleotide API development and manufacture.

Shimadzu System Combines HPLC and UHPLC Methods

July 22, 2016

In the Lab

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8

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

Catalent to Commercially Supply Palatin FSD Pen Injectors

July 22, 2016

Contract Services Update

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8

The pen injectors will be produced at Catalent’s Brussels, Belgium facility.

Zenith Appoints Serialization Director

July 22, 2016

Supply Chain Update

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8

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

CSafe Opens Facility in Puerto Rico

July 22, 2016

Supply Chain Update

11

8

The company opened a new service center in San Juan, Puerto Rico.

Recipharm Expands Blow-Fill-Seal Capacity at France Facility

July 22, 2016

Contract Services Update

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8

The company will invest €18 million in its Kaysersberg facility to expand blow-fill-seal capacity.

Packaging Facility Gets FDA Warning Letter

July 21, 2016

Supply Chain Update

11

8

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

Vetter Plans Expansion in Illinois

July 20, 2016

Contract Services Update

11

8

The company plans to purchase and develop an 18-acre site in Des Plaines, Illinois.

Cambrex Corporation Completes Expansion at Iowa Facility

July 19, 2016

Contract Services Update

11

8

The company invested $50 million in an expansion at its Charles City, Iowa facility.

SGS Invests in Genotypic DNA Sequencing System

July 19, 2016

In the Lab

11

8

The company invested in the MicroSeq Rapid Microbial Identification System from Applied Biosystems at its Illinois facility.

EAG Inc. Rebrands Businesses, Including ABC Labs, as EAG Laboratories

July 12, 2016

Contract Services Update

11

8

EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.

UPS Expands Capabilities for Drug and Vaccine Research

July 11, 2016

Supply Chain Update

11

8

UPS will expand its clinical trial logistics capabilities to include drug and vaccine development.