Top News

A Franchise Approach to the Modular Industry

Apr 23, 2015

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

Apr 23, 2015

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Highlights from INTERPHEX 2015

Apr 22, 2015

INTERPHEX 2015 is under way and Pharmaceutical Technology and BioPharm International are in the middle of the action!

Industry News

Sonneborn Announces New CFO

Apr 24, 2015

Sonneborn announces that it named Gregg Kam as its new chief financial officer.

L. B. Bohle’s Technology Center Merges All Steps of Continuous Production

Apr 22, 2015

With the inauguration of the Technology Center, the engineers, scientists, pharmacists, and IT developers for the first time closed the loop control circuit of a modular system along the entire process including production, sensor technology and controlling.

Endolysin Technology Presents an Antibiotic Alternative with Broad Applicability

Apr 21, 2015

Endolysin technology targets unwanted bacteria, including resistant strains.

Supplier News

Sartorius Unveils New Concept for Packaging Pipette Tips

FlexiBulk tip packs save space and effort in the laboratory

Sartorius Stedim Biotech Acquires BioOutsource

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

CPhI Japan Set for April 22-24 in Tokyo

Japanese pharma market evolves towards generics and innovative products, reports CPhI, as CPhI Japan 2015 commences.

Bio/Pharma News

Hospira Recalls Bupivacaine HCl Injection

The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.

EMA Recommends Authorization of Melanoma Treatment

The agency has recommended granting marketing authorization for Opdivo.

Teva Proposes $40 Billion to Acquire Mylan

Teva announces that it would pay up to $40 billion in cash and stock to acquire Mylan.

Peer-Review Research

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

L. B. Bohle’s Technology Center Merges All Steps of Continuous Production

With the inauguration of the Technology Center, the engineers, scientists, pharmacists, and IT developers for the first time closed the loop control circuit of a modular system along the entire process including production, sensor technology and controlling.

Gauging Change in Europe’s Sterile Manufacturing Market

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

India May Take WTO Action after EMA Drug Suspension

India may go to the World Trade Organization if the EU does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences.

Drug Development

Dicerna Receives Orphan Drug Designation for PH1 Treatment

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

MaxCyte Partners with Johns Hopkins on CAR T-Cell Therapies

MaxCyte announces a strategic partnership with Johns Hopkins University to develop CAR T-Cell therapies for cancer.

Current Issue

More Evidence that Size Matters

Big service providers get bigger faster thanks to Big Pharma.

Drug Discovery and Development in India

Hope abounds for local drug discovery companies despite challenges at home.

Modern Manufacturing Systems Key to FDA Quality Initiative

More reliable operations would accelerate product development and prevent drug shortages.

PharmTech Talk

Serialization: Deja Vu All Over Again?

As a special session at Interphex 2015 this week made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.

Gauging Change in Europe’s Sterile Manufacturing Market

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

Antibiotic Drug Development Makes a Turning Point

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

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.

USP Supply Chain Safety Videos

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.