Top News

FDA Approves First-of-its-Kind RNA Therapy

Aug 13, 2018

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

EMA Scales Back Activities to Prepare for Brexit

Aug 09, 2018

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

Cambrex to Acquire Halo Pharma for $425 Million

Jul 23, 2018

The acquisition will place Cambrex into the finished dosage form CDMO market.

Industry News

First Generic Version of EpiPen Gets Approval

Aug 17, 2018

FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

Repeat Quality Deviations Found at India Facility

Aug 16, 2018

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

Three FDA Grants Support Research in Modernizing Pharmaceutical Manufacturing

Aug 16, 2018

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Supplier News

Emergent to Acquire Specialty Vaccines Company PaxVax

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

FDA Approves Drug Product Manufacturing for Samsung BioLogics

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

FDA Issues Warning Letter to Canadian API Manufacturer

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

Bio/Pharma News

Emergent to Acquire Specialty Vaccines Company PaxVax

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

GSK Plans to Close Facility in Ireland

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

Astellas Acquires Gene Therapy Company Quethera

The acquisition will strengthen Astellas Pharma’s position in ophthalmology.

Drug Development

Application of API-in-Capsule Best Practices to Accelerate Drug Product Development

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

Selecting Excipients for Liquid-Filled Hard Capsules

Thixotropic gels, thermosoftened systems, and self-emulsifying systems have expanded the range of potential excipients for liquid-filled hard capsules (LFHC).

A Perspective on the Topical Delivery of Macromolecules

The authors review the potential of delivering aptamers to the skin, with evidence that therapeutically relevant levels can be reached in both the epidermis and dermis.

Drug Manufacturing

Robotics Solve Aseptic Filling Challenges

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Paving the Way for Modernized Drug-Product Manufacturing Through Excipients

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.

Testing Topicals: Analytical Strategies for the In-Vitro Demonstration of Bioequivalence

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

Best Practices

The Power of In Vitro Assays in Immuno-Oncology

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Modular Facility Design Maximizes Space Flexibly

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

INTERPHEX to Hold Keynote Series on Aseptic, Sterile, and Biologics Drug Manufacturing

Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.

Standards/Regulations

Pharmaceuticals in the Environment

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

FDA Forms Drug Shortages Task Force

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

EU and Japan Strengthen Collaboration on GMP Inspection

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

Sponsored Videos

PharmTech Talk

FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

More consistent and reliable production processes are critical for advancing innovative treatments.

FDA Seeks to Revive Quality Metrics Initiative

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

FDA Opens Door to Importing Drugs

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.

PharmTech Europe News

GSK Plans to Close Facility in Ireland

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

University of Warwick Develops New Method for Screening Polymeric Antimicrobials

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.

EMA Scales Back Activities to Prepare for Brexit

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

PharmTech eBook Series

 

Biologics and Sterile Drug Manufacturing 2018 eBook

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.  

View E-Book

 

Peer-Review Research

Oral Delivery of Macromolecular Drugs

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

A Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Sponsored eBooks

 

Strategies for Accelerating Drug and Process Development
This eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development.

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CPhI Update

Generics Drive Finished Drug Market Growth in Korea

CPhI Korea to feature zone for finished dosage formulation drug products.

Call for Entries: 2018 CPhI Pharma Awards

Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.

Cross-Industry Expertise Can Promote Manufacturing Improvements

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

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