Top News

House Committee Approves 21st Century Cures Legislation

May 21, 2015

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Compounding Center to Pay $200 Million for Meningitis Outbreak

May 20, 2015

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

EMA Revises Guideline on Clinical Development Requirements for Fixed Combination Products

May 20, 2015

The new guideline replaces the previous version—CHMP/EWP/240/95 Revision 1.

Industry News

CVS Inks Deal to Acquire Omnicare for $12.7 Billion

May 21, 2015

CVS Health signed a definitive agreement to acquire Omnicare for $12.7 billion to expand its reach to assisted living and long-term care facilities.

Symbiosis Launches Bulk Lyophilization Service

May 20, 2015

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

Mitsubishi Introduces New Plastic Syringe and Vial for Parenteral Pharmaceuticals

May 21, 2015

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Supplier News

CMC Biologics Expands Denmark Facility

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

Endo Acquires Par for $8.05 Billion

The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.

European Fine Chemicals Group (EFCG) to Hold Annual Dinner during CPhI Worldwide

The dinner will be held on Oct. 14, 2015 during CPhI Worldwide, at the Prado Museum in Madrid.

Bio/Pharma News

Medicago Plans Vaccine Facility In Quebec City

Medicago's new production facility will make plant-based vaccines and therapeutics.

Merus and Selexis Receive Grant for Bispecific Antibody Therapeutics

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

Alexion to Build Biologics Facility in Ireland

Alexion will construct a biologics facility in Ireland that is its first outside the US.

Peer-Review Research

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

Silver’s antimicrobial effects have been recognized since ancient times. The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

The Human Microbiome Project and Pharmaceutical Quality Control Microbiology

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.

Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time Imaging

The pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.

Drug Manufacturing

House Committee Approves 21st Century Cures Legislation

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Medicago Plans Vaccine Facility In Quebec City

Medicago's new production facility will make plant-based vaccines and therapeutics.

Janssen Expands Partnership with Rutgers for Continuous Manufacturing Research

Janssen pledges $6 million to Rutgers CSOPS for continuous manufacturing research.

Drug Development

Pluristem’s PLX Cells Satisfy Prerequisites for Fast-Track Approval in Japan

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

Juno Expands CAR T-cell Pipeline with $59 Million Acquisition

Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.

Current Issue

Transdermal Drug Delivery Gains Traction

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.

Pharma APIs: It’s Still a Small World

Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs.

Virtualized Infrastructure Takes Hold in Pharma Process Automation

Virtualization has been mainstream in information technology (IT) for decades.

USP Supply Chain Safety Videos

PharmTech Talk

Baxter BioScience Expands Oncology Business

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

QbD and PAT: A Marriage Made in Heaven?

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

Capsugel Produces DPI Phase 2 Trial Supplies

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

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

Considering GMPs In Room Design

Cleanability is crucial when choosing components for GMP manufacturing areas.

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

Lyophilization Cycle Optimization of Cell-Derived Products

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

Improving Visual Inspection Practices

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.

eBook Series

Solid Dosage and Excipients 2015 eBook

Pharmaceutical Technology's 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices for solid- and semi-solid dosage forms.

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.