Author Archives: BPI Contributor

Best Practices for Ensuring High Virus Clearance When Using Anion Exchange Membrane Adsorbers

This webcast features: Sherri Dolan, Global Technology Consultant, Separations Marketing Group, Sartorius Stedim Biotech The risk of viral contamination is a concern for all biopharmaceuticals and vaccines derived from cell lines and can have serious implications. Contamination events can cost millions of dollars in investigation, clean-up, corrective action, and manufacturing plant downtime. Most importantly, such events pose a safety risk to the patient. To ensure the safety of biological products, regulatory agencies require manufacturing processes to have a validated current…

Scalability of Lentiviral Production with the CTS LV-MAX Lentiviral Production System in Bioreactors

The Gibco™ CTS™ LV-MAX™ Lentiviral Production System provides a scalable and high-yield lentiviral vector (LV) production platform. It is based on a high-density suspension culture of HEK293F–derived Viral Production Cells that have been optimized for viral production in chemically defined LV-MAX Production Medium. Scalable LV production of greater than 1 x 10⁸ TU/mL LV (unconcentrated) can be achieved using our proprietary lipid nanoparticle transfection reagent in combination with an LV-specific enhancer and production supplement. All components work synergistically to help…

Technology Transfers – A Beginner’s Guide

Pharmaceutical developers are increasingly relying on external manufacturing partners for expertise to develop and commercialize their products. In fact, contract development and manufacturing organizations (CDMOs) now process and manufacture approximately 28 percent of the world’s prescription and non-prescription drugs. Innovation is coming from all corners of pharma including independent labs, scientific consortia, academia and government programs. These emerging sources of drug innovation often have excellent science but few resources and a lack of experience in commercializing formulations and drug product…

Bioprocess Selection and Economics: 5,000-L DynaDrive™ Bioreactor Shifting the Paradigm

This webcast features: Jeff Johnson, Founder and President, BioTech Design, LLC, Mark Thomas Smith, R&D Engineer, Thermo Fisher Scientific, and Kevin Mullen, Senior Product Manager, Thermo Fisher Scientific Single-use technologies enable a flexibility and modularity effectively unattainable with more traditional stainless-steel technologies, particularly in upstream bioprocesses. Single-use bioreactors up to 2,000 L are employed largely in preclinical- and clinical-stage bioprocesses to leverage this flexibility. As products reach commercial maturity, scales larger than 2,000 L frequently become desirable to take advantage…

Future Proof Your HCP Strategy

Future proof your HCP strategy. Four questions to help you decide if your HCP analysis data is ready for next phase approval. Host cell proteins (HCPs) are a primary source of impurities in biologics development. Scientists must detect and remove HCPs to ensure patient safety and meet regulatory guidelines. If previously undetected HCPs are found in later phases of clinical trials, scientists will need to redesign the drug substance purification strategy – adding financial and time costs that can create…

FPLC Column Selection Considerations

This webcast features: Dan Yukon, Head of North American Sales and Global Sales of SNAP Products, Astrea Bioseparations This presentation will outline various selection criteria when considering glass fast protein liquid chromatography (FPLC) columns for low-pressure chromatography. The topics will include: pressure and volume considerations column configuration (aspect ratio) materials of construction frit type, design porosity, and mounting connection types adjustability construction accuracy packing tube design storage. There are many types and brands of columns available on the market, and…

CMC Testing Support for Gene and Cell Therapy

Eurofins BioPharma Product Testing supports the development of ATMPs both for traditional use as well as for use in personalized medicine. We provide comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation. Testing Capabilities include Raw Materials, Cell Banks, Virus Banks, Plasmid Vector, Harvest (Lot Release Testing), and Bulk & Finished Products. We support gene therapies,…

Revealing Cell Secrets with Optical Sensors in Upstream Bioprocessing

This webcast features: Jake Boy, Senior Application Scientist, Scientific Bioprocessing Single-use optical sensors play a critical role in upstream bioprocessing. Scientific Bioprocessing has developed sensors with a form factor suitable for the smallest culture vessels so that data can be obtained from the very early stages of research through scale-up in larger reactors. Our intelligent, dynamic, and real-time monitoring of pH and dissolved oxygen challenges traditional culture protocol assumptions and offers insights into the conditions that cells are actually experiencing.…

Single-Use Technologies: Innovation and Performance

The biotherapeutic market has been rapidly adopting single-use technologies to reduce risk and improve operational efficiencies. For more than 20 years, Thermo Fisher Scientific has pioneered single-use technologies for this industry. Our products have been proven to be robust and scalable from laboratory scale-up to current good manufacturing practice (cGMP) production applications, including single-use bioprocessing equipment, flexible containment, and rigid containment product portfolios. Our webinars will explore data, innovative products, and novel strategies featuring single-use solutions for the bioprocessing market.…

ELEVECTA – The future of AAV gene therapy vector production

Pharmaceutical companies with gene therapies in their pipeline need to establish scalable production processes that can keep up with the increasing demand in terms of volume, quality and robustness, says CEVEC. Gene therapies are seen as one of the most promising approach to treat life-threatening diseases with no therapeutic options and high medical needs.  In addition, gene therapies are now advancing also into indications with larger numbers of patients, including Alzheimer’s and Parkinson’s, thereby dramatically increasing the demand for viral…