Top News

Generic Opioids Create Policy Issues

May 27, 2015

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

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.

Industry News

FDA Releases Guidance on CMC Changes for Biologics

May 29, 2015

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

ICH Steering Committee to Meet in Japan

May 29, 2015

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

Supplier News

Waters Announces New Mass Spectrometry Technology

Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.

Intertek Opens GMP Pharmaceutical Stability Storage Facility in Cambridge, UK

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

Bio/Pharma News

Innovative Inhaled Antipsychotic Formulation Adasuve Provides Quick and Effective Treatment

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or biopolar I disorder.

Visterra Announces Partnership to Develop a Monoclonal Antibody

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.

Boehringer Gains FDA Approval of COPD Treatment

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

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

Aging Facilities: Aseptic Manufacturing Faces the Future

Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.

Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Intertek Opens GMP Pharmaceutical Stability Storage Facility in Cambridge, UK

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

Drug Development

Generic Opioids Create Policy Issues

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

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

Generic Opioids Create Policy Issues

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

“Cures” Debate Far From Over

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

Fight Over Biosimilar Naming Continues

As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.

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.

PharmTech eBooks

 

Bioprocessing and Sterile Manufacturing eBook
The editors examine novel sterile and bioprocessing technologies including single-use systems, aging systems, cleanrooms, and lyophilization.  View eBook

 

More eBooks
Solid Dosage and Excipients
Analytical and Bioanalytical Testing