Product Lifecycle Management Jayne Hesley, applications scientist in marketing for Molecular Devices, Inc. (Sunnyvale, CA) Homogeneous Antibody Binding Assay: Comparing Imaging Systems and Optimizing Acquisition Parameters for High-Throughput Screening Hybridoma cell lines are cultured to produce monoclonal antibodies for use in diagnostics, vaccine development, or therapeutics. One well-accepted assay for screening the antibody-containing supernatant of hybridomas is to capture the antibody on the surface of beads (
Author Archives: BPI Contributor
IBC’s 14th Annual Well Characterized Biologicals Practical Case Studies, Analytical Strategies, and Regulatory Perspectives for Protein Product Characterization
IBC’s Well Characterized Biologicals conference is the top forum for hearing industry case studies and unpublished new data on the challenges, strategies, and technologies involved in protein characterization. Register now for exclusive access to meet FDA reviewers and industry experts who will share their insights to help you implement new approaches and avoid common pitfalls in your own characterization projects. Hear first-hand from FDA reviewers about their “pet peeves” and suggestions to help you improve your IND packages and characterization…
Global Marketplace
Single-Use Bioreactors Product: Modular, integrated bioreactors Applications: Single-use cell culture Features: PBS Biotech has introduced its “next-generation†single-use bioreactors. The first three models support maximum working volumes of 3 L, 15 L, and 80 L to support expansion and process scale-up from R&D to pilot plants. The modular, preconfigured bioreactors feature an integrated controller with a graphical user interface, proprietary low–shear-stress Air-Wheel agitation, automated sampling, and an on-board database. Each unit is built to order,…
Quality, Speed and Flexibility by Design
Accelerating the path to new biomanufacturing capacity typically corresponds with increased costs and the risk of lower quality. Overcoming these compromises requires a holistic QbD-based rethinking of how biomanufacturing is approached. By rethinking biomanufacturing equipment, facility design and services, Xcellerex has achieved dramatic improvements in deployment time, while also reducing capital investment, operating costs, and improving overall quality and compliance. This webcast discusses the advantages of the FlexFactory® Biomanufacturing Platform, such as:
• Multi-product, simultaneous manufacturing
• Open platform for any bioprocessing technology/process control
• 70% reduction on time to build/validate to GMP ready (9mo.)
• And more.
Join Parrish Galliher, Founder and Chief Technology Officer at Xcellerex, as he provides an in-depth look at the technology behind Xcellerex’s FlexFactory Biomanufacturing Platform.
Industrial Purification with Convective Interaction Mediaâ„¢ Monoliths
Monoliths offer a unique set of characteristics that, when properly applied, can significantly improve the overall productivity of the manufacturing processes. In this educational webcast, Tony Brazzale of BIA Separations explores the technology behind the CIMâ„¢ Monolithic Columns and its many benefits, including:
• Increased facility capacity
• Accelerated ROI
• Improved productivity
• Reduced cost of labor and overall COGS
View this educational webcast to learn more about how CIM Monolithic Columns can improve your manufacturing process.
A Novel Filtration System Used to Intensify Upstream and Downstream Operations
Want to improve your bioprocess? The ATFâ„¢ System from Refine Technology was designed to do just that. Used in various bioprocessing applications, this system provides a more reliable and efficient process of cell separation with the inherent ability to support cell growth to extreme concentrations. This educational webcast discusses the Alternating Tangential Flow technology of the ATF System and its many benefits, including:
• Near-linear scale-up
• A filtered product stream ready for purification
• Faster, simpler virus production with a reduced cost of goods
• And more
Join John Bonham-Carter, VP of Sales and Business Development at Refine Technology, as he provides a detailed look at the ATF System, its applications and its benefits.
pDNA Production and Purification
In recent years, there has been a growing demand for DNA-based therapeutics, commonly known as gene therapy, to combat genetically-based pathologies. Because plasmid DNA have significantly different biophysical characteristics than proteins, their production can have a drastic impact on downstream purification unit operations. Join Dr. Stephen Palmieri and Dr. Jesse McCool of Lonza Biologics and Dr. Fred Blattner of Scarab Genomics as they take a detailed look at the challenges faced by pDNA manufacturers and how Lonza’s pDNA Production Platform addresses those challenges.
Global Marketplace
Bioreactor Scale-Up Product: Micro-24 MicroReactor system Applications: Early stage microbial process development Features: With Pall Corporation’s acquisition of California-based MicroReactor Technologies, Inc. in January 2010, Pall Life Sciences offers the Micro-24 system. It features a disposable 24-reactor cassette, each reactor with fully independent control of temperature, pH, and dissolved oxygen. The miniature bioreactors enable rapid, high-throughput process development with accurately scalable results. The systems simulate the performance of stirred-tank bioreactors from bench (1–20 L) up to 200,000 L. Contact Pall…
BioProcess International Conference and Exhibition
IBC’s BioProcess International conference and Exhibition has become the largest, most well-respected forum that focuses solely on technical, regulatory, and strategic planning challenges in the manufacture of biotherapeutics. This event is truly the place to gain the latest industry updates, make new contacts and initiate collaborations in biopharmaceutical production. Why? Four comprehensive tracks will update your knowledge in all areas of bioprocessing at one outstanding forum Managing Manufacturing Networks: Maximize your present and future facilities from experience with biodefense, subcutaneous…
Technology Transfer of CMC Activities for MAb Manufacturing
As monoclonal antibody products succeed and advance through development, their manufacturing requirements change. The probability of a smooth and successful technology transfer process depends on several factors. Sending and receiving parties must be well aligned in expectations, which can be facilitated by early and detailed planning and communications.
To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory and strategic chemistry, manufacturing and control (CMC) activities necessary to successfully advance new MAbs from discovery to first-in-human clinical trials and the market as quickly and economically as possible. Read this informative white paper to learn more.