Top News
DHSC Directs Pharma to Stockpile Medicines
Aug 23, 2018
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
UK Outlines Potential Pharma Changes Post-Brexit
Aug 23, 2018
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
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.
Industry News
Swedish Government and GE Healthcare Open an Innovation Center for Life Sciences
Aug 24, 2018
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
DHSC Directs Pharma to Stockpile Medicines
Aug 23, 2018
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
UK Outlines Potential Pharma Changes Post-Brexit
Aug 23, 2018
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
Supplier News
Swedish Government and GE Healthcare Open an Innovation Center for Life Sciences
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
Catalent Acquires Juniper Pharmaceuticals
The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.
Leaf Expression Systems’ Facility Begins Operations
The company’s purpose-built facility in Norwich, United Kingdom specializes in plant-based expression of proteins, metabolites, and complex natural products.
Bio/Pharma News
FDA Approves First Drug for Rare Eye Disease
Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
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.
Drug Development
Disputes Over SPC Waivers
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
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).
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
Disputes Over SPC Waivers
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
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.
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 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.
Congress and FDA Take Action to Combat Opioid Crisis
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
PharmTech Europe News
Swedish Government and GE Healthcare Open an Innovation Center for Life Sciences
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
DHSC Directs Pharma to Stockpile Medicines
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
UK Outlines Potential Pharma Changes Post-Brexit
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
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.
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.
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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Current Issue
The Challenge of Building Better Biologic Drugs
Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.
Modular Manufacturing Can Ease Bioprocessing Woes
Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Webcasts
Front & Center
Outsourcing
Swedish Government and GE Healthcare Open an Innovation Center for Life Sciences
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
FDA Approves Drug Product Manufacturing for Samsung BioLogics
Drug product approval from FDA follows previous approvals from European and Japanese authorities.
Outsourcing Glycan Analysis
Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.
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