The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016. / read more /
Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy. / read more /
A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland. / read more /
Ensuring Effective Drug Stability Studies Drug Stability Testing from Development to Shipping
LIVE WEBCAST: US: Wednesday, April 20, 2016 at 11 am EDT and EU: Wednesday, April 27, 2016 at 11 am CEST In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Free registration
The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters. / read more /
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted. / read more /
The revised USP Chapter <1207> Sterile Product Packaging—Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods. / read more /
Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry. / read more /
Asking the right questions is crucial to establishing a biopharmaceutical facility design. / read more /
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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder
LIVE WEBCAST: Tuesday April 26, 2016 at 7 am PDT | 10 am EDT | 2 pm GMT | 3 pm BST | 4 pm CET When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
Free registration
USP <857> Certified Reference Materials
The new Starna USP kits provide all the appropriate liquid reference materials, in a permanently heat-fused sealed format, so that the required parameter verification to specific instrumental requirements can easily be performed.
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SMA OneTouch ICS
The SMA OneTouch ICS is a computerized, automated, viable air monitoring system that controls, calibrated and precise air sampling through individual or multiple SMA Atriums®.
/ Read more /
Event Profile
Chemspec Europe 2016 Date: 1 – 2 June 2016 Venue: Basel Messe | Basel, Switzerland
Chemspec Europe is dedicated to the fine, custom and speciality chemicals sector and because of its focussed profile a must for international industry decision makers. Establish new business contacts and discuss the latest results in R&D at top-class conferences.
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KEYNOTE SERIES AT INTERPHEX 2016
At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.
In a panel discussion, Industry experts will discuss how technology advances are addressing challenges in biopharmaceutical development including quality control of raw materials, implementation of single-use technologies, process monitoring, and downstream purification.
Tuesday, April 26, 10:15 am to 11:45 am Learn more
Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 4:30 pm Learn more
Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells. Sponsored by Eurofins Lancaster Laboratories
On Demand
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs. Sponsored by SGS Life Science Services
Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development. / Click here /
New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
