As cell line development and engineering mature, this industry faces new challenges and new lines of questioning. Where is the need for innovation? What enabling technologies will provide which companies with advantages over their competition? How can we leverage continued improvements to increase the speed of clinical and manufacturing facilities? How much can we improve understanding and development by applying “CHO-omics” and highthroughput systems? Do we have the tools to process and analyze all the available data? As biosimilars gain…
Author Archives: BPI Contributor
Global Marketplace
Technical Services Service: Pall Scientific and Laboratory Services (SLS) group Applications: Downstream processing Features: Established >40 years ago, Pall’s SLS group employs experts in chromatography, viral clearance, liquid and air filtration, microbiological process monitoring, tangential-flow and depth filtration, and blood processing. Services offered include validation, consulting, process development and proteomics, preinspection reviews, contamination analysis, and training. Instrument services include calibration, servicing, upgrades, documentation, qualification and technical support. Contact Pall Life Sciences www.pall.comSpectrophotometry Product: Evolution 200 series Applications: QA/QC analyses Features:…
Building a Bridge to Commercial Success
The history of the biopharmaceutical industry is one of continual invention and reinvention, of business models that have adapted to weather uncertain product futures and shifting economic fortunes. Some of us followed the up-and-down (and often financially painful) progress of monoclonal antibodies toward their eventual commercial success — a wealth of experience to draw from as other classes of products make their way from laboratories and onto the market. The vast majority of regenerative medicines are still produced at laboratory…
Global Marketplace
Tubing/Hose Clamps Product: Overmolded Tri-Clamp ends Applications: Sanitary fluid management, single-use processing Features: AdvantaPure Overmolded Tri-Clamp ends for PVC, TPE, and TPR tubing and hoses are injection molded from USP Class VI Hytrel material or polypropylene in Tri-Clamp and Mini Tri-Clamp styles. A smooth transition from tubing to clamp reduces bacteria entrapment potential for cleaner connections. The clamp materials are mated thermally (no leachable adhesives) to PVC, TPR, or TPE hoses and certified free of animal-derived ingredients. Miniature through1.5-in. Tri-Clamp…
TIDES Oligonucleotide and Peptide Research, Technology, and Product Development
TIDES is the only event that covers CMC manufacturing of peptide and oligo therapeutics in depth. It offers the largest showcase of providers of services and technology critical to the field and a proven track record of attendance that guarantees a superior networking opportunity. TIDES 2011 has four main content streams: Oligonucleotide and Peptide Manufacturing Technology and Product Development; Oligonucleotide Therapeutics Discovery; Peptide Discovery and Development; and Nucleic Acids Technologies for Molecular Diagnostics. Learn how to solve your CMC manufacturing,…
Modeling Perfusion Processes in Biopharmaceutical Production
Biopharmaceutical manufacturing is mostly batch-based for a number of reasons: lower perceived contamination risks, batch-to-batch segregation, and historical legacy. Despite those reasons, perfusion is used by a number of biomanufacturers because it produces large product quantities using smaller bioreactors than would be possible with batch-based production.
Though perfusion-based production presents challenges that confound traditional models, it can create an environment in which many more factors can be influenced to directly optimize production. Read this case study to learn more about how perfusion can be used to create flexible, “just-in-time†facilities that respond to manufacturing conditions.
Global Marketplace
Laboratory Automation Product: Octet platform Applications: Label-free molecular binding analysis Features: ForteBio chose Hudson Robotics to provide automation capability for its Octet biolayer interferometry analytical instruments. The platform includes Dip and Read biosensors, reagents, and assay kits for analyzing biomolecular interactions in 96-and 384-well microplates. The two companies developed out-of-the-box, integrated automation for Octet QK384 and RED384 systems with Hudson’s PlateCrane EX robotic arm and Micro10x robotic reagent dispenser. A bar-code scanner reads and records…
IBC’s 26th International Antibody Development and Production Part of IBC’s Biopharmaceutical Development and Production Week
IBC’s Antibody Development and Production conference offers the latest technical and scientific advances in bioprocessing to help companies of all sizes improve speed, quality, and cost in developing and producing antibodies. Exclusive case studies deliver the latest data together with strategic discussion forums that allow the industry’s leading scientists, engineers, and executives to collaborate and find solutions to their most pressing challenges. Gain from companies sharing “lessons learned” from their own experiences developing and optimizing processes and production of antibody-based…
Global Marketplace
Packaging Service: Flexible options in final assembly and secondary packaging Applications: Drugs and biologics Features: An international specialist in aseptic fill–finish, Vetter offers a range of options for final assembly and packaging of pharmaceutical and biotech products. The company provides semi- and fully automated secondary packaging; labeling, blistering, cartoning with package inserts, and case packing; assembly of pens, autoinjectors, and other safety devices; and high standards of cosmetic integrity. Contact Vetter Pharma International GmbH www.vetter-pharma.com Microbioreactors Product: ambr workstation Applications:…
IBC Life Sciences US 2011 Calendar
IBC Life Sciences has been supporting and supplying the life science industry with specialized information through conferences and courses since 1987. IBC Life Sciences events offer attendees the opportunity to gain new insights and hear latest developments as well as provide a forum to meet, connect, and network. New Directions for Diabetes Therapeutics (16–17 February 2011): Hilton Boston Back Bay, Boston, MA Viral Safety for Biologicals (24–25 February 2011): Walt Disney World Swan Resort, Lake Buena Vista, FL AsiaTIDES (2–4…