Top News

GlaxoSmithKline to Keep Vaccine Prices Low for Gavi Members

Jan 27, 2015

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site

Jan 23, 2015

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions.

EMA Sets Elemental Impurities Implementation Dates

Jan 23, 2015

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Industry News

Vetter Expands Ravensburg Site

Jan 29, 2015

Structural work has completed for the new building, which will contain laboratory space for performing microbiological analysis as well as a data center.

Recipharm Completes China-Focused Serialization Project

Jan 28, 2015

Recipharm has completed a serialization project for China on behalf of one of its customers.

SGS Expands West Chester Facility and Increases Protein Structural Analysis Services

Jan 27, 2015

The company has installed and validated new instruments for structural analysis of proteins.

Supplier News

PPD Announces Completion of Clinical Studies Facility in Ireland

PPD announced that it completed an expansion to its Athlone, Ireland facility, resulting in 20,000-square-feet of dedicated space for warehousing and distribution purposes.

Catalent Expands High-Potency Handling Capability

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

Ash Stevens to Manufacture Amotosalen API

FDA has approved the Ash Steven’s manufacturing facility in Riverview, MI for the manufacture of Amotosalen.

Bio/Pharma News

AstraZeneca Partners with MD Anderson on Cancer Therapy Development

AstraZeneca and the University of Texas MD Anderson Cancer Center announced a plan to collaborate for the improvement of patient outcomes in clinical trials with investigational therapies.

Piramal Invests $30.6 Million in Coldstream Acquisition

Piramal announced that it had invested $30.6 million to acquire Coldstream Laboratories facility and 100% of its shares, adding injectables to Piramal's pipeline.

Giovanni Caforio Named BMS CEO

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Peer-Review Research

Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological Indicators

In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

Comparing Manufacturing Process Options

A techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.

Considerations in Developing Sublingual Tablets—An Overview

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

Drug Manufacturing

Catalent Expands High-Potency Handling Capability

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

CDC Publishes Information on Reducing Worker Exposure to Hazardous Drugs

A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

Filling Pre-sterilized Containers

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

Drug Development

Vetter Expands Ravensburg Site

Structural work has completed for the new building, which will contain laboratory space for performing microbiological analysis as well as a data center.

EMA Sets Elemental Impurities Implementation Dates

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Investment into T-Cell Therapies Continues

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

Current Issue

How Accurate are Your Dilutions?

The choice of dilution schemes can minimize solution preparation errors.

Where is it Written?

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements

Fill/Finish Capacity Use for Biologics

There are significant differences between small molecules and biologics fill/finish capacity.

PharmTech Talk

Quality is Key

CPhI experts make predictions on pharma trends for 2015.

House Cures Proposal Faces Tough Road Ahead

Industry voices concerns over draft legislation that seeks to get much needed treatments to patients.

FDA Advisors Unanimously Approve Sandoz Biosimilar

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

PharmTech Europe

25th Anniversary Issue

Experts review bio/pharma industry growth and future prospects as Pharmaceutical Technology Europe marks its 25th anniversary.

 

 

 

PharmTech Europe Archives

 

Editor's Picks

Novel Technologies Win CPhI Pharma Awards

On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.

FDA Realigns Drug Inspection and Manufacturing Oversight

Operational changes at FDA and CDER aim to improve global market monitoring.

The Bio/Pharma Working Life

Professionals share the ups and downs of working in the bio/pharma industry.

Using Robotics In Pharmaceutical Manufacturing

Robots are proving advantageous in filling, inspection, packaging, laboratories, and the manufacture of personalized medicine.

USP Supply Chain Safety Videos

eBook Series

Analytical and Bioanalytical Testing eBook 2014

The editors of Pharmaceutical Technology review best practices and methods for analytical and bioanalytical testing.

Bioprocessing and Sterile Manufacturing

Review emerging trends in the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and single-use technologies.

Solid Dosage and Excipients

Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.