Top News

USP Establishes Elemental Impurities Implementation Dates

Apr 01, 2015

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities—Limits and Elemental Contaminants in Dietary Supplements.

Access to New Medicines Requires Transparency and Collaboration, Says WHO Report

Mar 26, 2015

The WHO report outlines possible policies that may help governments reduce the high prices of new medicines.

Valeant Adds $1 Billion to Salix Offer, Amid Bid Battle

Mar 16, 2015

Valeant announced that it would increase its original acquisition agreement with Salix to approximately $15.8 billion.

Industry News

FDA Issues Guidance on NIR Analytical Procedures

Mar 30, 2015

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The White House Responds to Superbug Threats

Mar 27, 2015

The White House confirmed that it would commit $1.2 billion to tackle the growing problem of antibiotic-resistant superbugs.

Kemwell’s Bangalore Facility Completes Successful FDA Inspection

Mar 26, 2015

FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

Supplier News

Xcelience Receives DEA Approval for Schedule I Drug Products

Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.

Rentschler Commissions 2000-L Single-Use Bioreactor

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Genentech Expands Oregon Fill/Finish Site

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

Bio/Pharma News

Merck Joins CAR T-cell Market with $941 Million Intrexon Alliance

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Novartis Inks $250 Million Alliance with Aduro

Novartis announced that it entered into a multiyear alliance with Aduro Biotech to develop cancer immunotherapies, offering up to $250 million in upfront payments and equity investments.

Horizon Offers $1.1 Billion for Hyperion

Horizon Pharma offers to buy Hyperion Therapeutics for $1.1 billion in cash.

Peer-Review Research

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.

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.

Drug Manufacturing

Genentech Expands Oregon Fill/Finish Site

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

WuXi PharmaTech To Build New Cell Therapy Manufacturing Facility

WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.

Nanobiotix Appoints CordenPharma as Manufacturing Partner

The manufacture and scale up production mark a significant milestone in the commercialization route of Nanobiotix lead product, NBTXR3.

Drug Development

The White House Responds to Superbug Threats

The White House confirmed that it would commit $1.2 billion to tackle the growing problem of antibiotic-resistant superbugs.

BMS Acquires Autoimmune Portfolio from Novo Nordisk

Bristol-Myers Squibb acquired an exclusive license for Novo Nordisk’s discovery biologics research program.

Emergent Dives Further into the Anthrax Treatment and Vaccine Market

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

Current Issue

USP Publishes Monoclonal Antibody Guidelines

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

CMOs Plan for Capacity Expansions

Is there enough talent to go around?

Removing Aggregates in Monoclonal Antibody Purification

Several chromatographic resins are available for downstream purification.

PharmTech Talk

Stronger Pipelines and Approvals Drive Small-Molecule APIs and CMO Opportunities

Statistics presented in a March webinar suggest a strong, but highly fragmented, small-molecule API market

Hamburg Era Ends at FDA

Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.

Industry Responds to FDA Labeling Rule

Drug makers back alternative to FDA labeling update rule.

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

Improving Visual Inspection Practices

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

Developing and Validating Assays for Small-Molecule Biomarkers

Working with biological matrices and understanding the intended use are crucial.

Gauging the CMO Biosimilar Opportunity

Market forces may limit the success of CMOs.

FDA Sets Policies to Enhance Drug Security and Safety

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

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.