The mainstream adoption and success of mobile, single-use manufacturing platforms, combined with the introduction of off-site training programs provide companies with the ability to quickly set up and operate fully functioning biomanufacturing facilities globally.
Saturday, September 1, 2012 Daily Archives
cGMP Operational Excellence and Infrastructure Harmonization from Lab to Plant
This presentation outlines the key issues facing the R&D and Quality cGMP environments and presents key IT-based solutions that have been implemented by leading pharma and biotech companies.
Production of a Viral-Vectored Vaccine Candidate Against Tuberculosis
Vaccines are among the most efficacious and cost-effective human health interventions available. They provide protection against a surprisingly broad spectrum of infectious diseases. Notable recent successes protect against human papillomavirus (Cervarix and Gardasil vaccines from GlaxoSmithKline and Merck, respectively) and rotavirus (Rotarix and RotaTeq vaccines from GlaxoSmithKline and Merck, respectively). However, generating reliable sterilizing or therapeutic immunity is still not possible against a number of latent and chronic pathogens that especially affect people in developing countries. Among those…
How an Obscure Asian Rodent Took Over Biotechnology
The earliest domestic rodents were cavies (“Guinea pigs”) kept as food animals in the Andes since 5000 BC (as shown by mummified cavies) and carried to Europe in the 16th century (Elizabeth I had one as a pet). Although rats weren’t domesticated until the mid-19th century (a byproduct of the blood sport of rat-baiting), mouse selection and breeding began many centuries earlier. Selection of unusually colored mice was first documented ~1100 BC in China, and breeding such “fancy” mice as…
BioProcess International Conference and Exhibition
Expand your knowledge with unparalleled access to new, unpublished data and exclusive case studies from companies of all sizes and perspectives at the most comprehensive event for those directly involved with improving the speed, cost, and quality of developing and manufacturing biotherapeutics. This event will help you improve manufacturing and development efficiency, enhance process understanding and quality, advance cell culture and upstream processing, streamline recovery and purification, and optimize the quality and novelty of your next-generation biologic drug products. To…
Global Marketplace
Product Development Service: Contract development and manufacturing Applications: Clinical- and commercial-scale complex biologics Features: Therapure Biopharma specializes in biologics development, scale-up, and manufacturing. At its 130,000-ft2 CGMP facility in Toronto, Ontario, Canada, the company offers cell-line, process, and analytical development; product manufacturing and testing; and aseptic fill–finish and lyophilization. It has >20 years of experience working with mammalian and primary cell cultures, whole blood, and plasma sources. Contact Therapure Biopharma www.therapurebio.com Capsule Filters Product: CM…
Advancements in Processing That Optimize Samples for Future Research
Many factors contribute to the quality of biospecimen collections, and most are not mutually exclusive. How we assess the value of a biosample at the time of collection may be very different from at the time of analysis, which can be (and often is) an event in the distant future. To help ensure quality and create a sample resource that is not easily depleted, both novice and experienced “biobankers†can follow some general sample life-cycle management principles to…
Poster Presentations
Enhancing Manufacturing Development Efficiency Svetlana Dukleska (Merck) Early Research Stability Studies Can Aid in Rapid Screening of Potential Drug Candidates In a competitive research and development (R&D) space with tight time lines, it is important to have a toolbox of extended characterization and analytical assays for rapid screening of potential candidates. Additionally, early research stability studies can provide initial information on potential degradation pathways for screening candidates, for purification development, and for establishing stable formulations. Herein, we show…
Novel Single-Use Sensors for Online Measurement of Glucose
According to an FDA guidance document, process analytical technology (PAT) tools “are intended to support innovation and efficiency in pharmaceutical development†(1). The agency encourages manufacturers to use a PAT framework for developing and implementing effective innovative approaches in development, manufacturing, and quality assurance. The sensors described here are one possible response to the requirement of systems by analyzing and controlling critical cultivation parameters with real-time process measurements. Working Principle Glucose was measured using a #CITSens…
Formulation and Delivery
Biopharmaceutical formulation and delivery are more than science; they also must take into account patient preferences and behavior, the biology of diseases being treated, and even the concerns of legal, sales, and marketing groups. But science is the foundation. Formulation work has become more methodical and quantifiable thanks to advancing analytical technologies — which brings quality by design (QbD) into formulation laboratories. The vast majority of biotherapeutics and vaccines are parenteral drugs — many of them lyophilized and…