All
Bioanalyte Analyzer Shortens Measuring Time
Beckman Coulter Life Science’s new Vi-Cell Metaflex is designed to be operational for more than 22 hours a day.
Tablet Coating Reduces Production Times
The Opadry QX from Colorcon is suitable for tablets containing temperature-sensitive active ingredients.
Plasticell Receives Queen’s Award for Enterprise in Innovation 2016
Plasticell was recognized for its contribution to the advancement of regenerative medicine, cell and gene therapy, as well as other areas of biomedical research.
US National Science and Technology Council Promotes Advanced Manufacturing
The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a biopharmaceutical facility design.
Pfizer Launches Newly Combined CMO
Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.
BÜCHI Rotavapor R-300 Receives Design Awards
BÜCHI Rotavapor R-300 received the German Design Awards 2016, the RedDot Award 21, and the iF International Forum Design Award.
NIH Suspends Research in Sterile Production Facilities
The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.
NIH Study Identifies Better Parameter to Predict Flu Vaccine Effectiveness
Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.
Walker Barrier Systems Products to be Rebranded as Extract Technology
Extract Technology’s portfolio will now include aseptic solutions, containment solutions, restricted access barriers, and mobile cleanrooms for the pharmaceutical, healthcare, biotech and chemical markets.
FDA Issues Guidance on Comparability Protocols
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.
PRAC to Review Canagliflozin and Direct-Acting Antivirals
PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.
Sanofi Invests €300 Million in Biologics Manufacturing Facility
Sanofi will invest in its Geel, Belgium facility in order to support its pipeline of monoclonal antibodies.
GSK Opens New Respiratory Manufacturing Facility
The facility located in Ware, UK, will be used to manufacture GSK’s Ellipta inhaler.
Shire Builds Biologics Manufacturing Campus in Ireland
Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.
Recipharm AB to Acquire Kemwell’s CDMO Businesses
Through two acquisitions, Recipharm will acquire Kemwell’s United States, Swedish, and Indian operations.
Gericke Establishes US Affiliate Company
The new affiliate company will be based in Somerset, New Jersey.
FDA Releases Data Integrity Guidance
The agency published guidance on data integrity as it is relates to CGMP compliance.
Seattle Genetics Presents New Antibody-Drug Conjugate Data at AACR
Linker technology and drug combinations play an important role in the efficacy of ADCs.
Kite Pharma Pauses Selected Clinical Trials
The National Institute of Health will conduct an internal review of the National Cancer Institute’s cell manufacturing facilities, which will affect multiple Kite projects.
FDA Blog Encourages Use of Continuous Manufacturing
FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
FDA Issues Three New Compounding Guidance Documents
The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.
Hospira Recalls Magnesium Sulfate Injection
The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.
IMS Institute Report Examines Medicine Use and Spending in 2015
The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.
EMA and EUnetHTA Release Collaboration Report
The agencies detail the results of their three-year collaboration.
FDA Releases Annual Report on Generics
The Office of Generic Drugs highlights the agency’s work to advance generic drugs.
ITT Corporation Diaphragm Passes ASME BPE Seal Test
The valve received the highest cycle rating after completing the test at three times the required test pressure.
Futureproofing the Pharmaceutical Industry through Technology
By focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.
Juno Therapeutics and WuXi AppTec form JW Biotechnology
JW Biotechnology will focus on developing novel cell-based immunotherapies.
Colorcon Adds New Film Coating System
The new system will be used for multiparticulate dosages.
