Author Archives: BPI Contributor
FlexFactory from Xcellerex – A Proven Biomanufacturing Platform Enabled by Disposables
FlexFactory from Xcellerex is a biomanufacturing platform that is transforming the way the biotechnology industry approaches drug production. Built almost exclusively around disposables technology, each unit operation within the FlexFactory is self-contained in its own controlled environment module (CEM), effectively shrinking the cleanroom around each operation.
In this on-demand webcast, Parrish Galliher, Founder & Chief Technical Officer of Xcellerex, demonstrates how the FlexFactory eliminates the need for expensive clean-room facilities and CIP/SIP infrastructure, resulting in:
• Reduction in Capital Investment by 50% or More
• 70% Reduction in Start-up Time
• 55% Reduction of Carbon Footprint
• Major reduction of Water Consumption
• Increased Flexibility
FlexFactory is the only biomanufacturing platform that delivers the speed and capital efficiency of the CMO approach with the control and long-term economics of company-controlled manufacturing. View this webcast to gain an in-depth understanding of the benefits of this innovative technology.
Follow-on Biologics
This webcast will describe the key steps in developing a CHO culture process for manufacturing a follow-on biologic. Analytical characterization of 14 lots of the commercial product provided information about the range in key product quality attributes of the marketed drug. The scientists at SP-Diosynth have developed a process that yields a product that is analytically comparable to the commercially available molecule. Product quality attributes investigated were aggregation, acidic and basic variants, galactose, sialic acid and fucose content, and complement dependent cytotoxicity activity.
Scalability of the process was demonstrated in 100L stainless steel bioreactors and a 50L single use bioreactor (SUB). The webcast shows SP-Dionsyth’s data indicated that the process generates high titer at scale consistently while achieving product quality similar to the commercial material.
With this on-demand webcast, you will gain valuable insight into aspects of SP-Disoyth’s process development, such as:
• Cell Line Characteristics
• Scalability
• Manufacturability
• Comparability
• Commercializability
The webcast features Sigma S. Mostafa, Ph.D.
Microbial Expression Technology: The New Standard For Protein Expression – Addressing Speed, Quality and Cost of Goods
A new paradigm of microbial strain development has been achieved that overcomes today’s slow, iterative and error-prone process through the use of a novel, streamlined, high throughput platform. The P. fluorescens expression platform, Pfēnex Expression Technology™, reliably delivers host strains expressing large amounts of high quality target protein within very short development times. In this webcast, Dr. Charles H. Squires, Head of Discovery R&D at Pfēnex Inc., discusses:
• An Overview of Pfēnex Expression Technology™
• How Pfēnex Inc. Practices the Technology
• Case Studies Highlighting the Power of the Technology
• Product Areas
• Further Uses of Pfēnex Expression Technology™in Development
Join Dr. Squires as he illustrates how the combination of technologies available through the Pfēnex Expression Technology™system make it the most complete, flexible and productive bacterial strain development and biopharmaceutical production platform available today.
Global Marketplace
Cryopreservation Product: CryoSolve single-use CGMP cell cryopreservation media Application: Cell cryopreservation Features: These single-use syringes with Luer-lock tips help eliminate sharps, avoid cross contamination, maintain sterility, and streamline your process. Raw materials are serum-free (USP/EP) and the medium has been shown to support an average cell viability of 97%. The products are manufactured under CGMP conditions with syringes made of USP Class VI glass, compatible with DMSO. All equipment passed compatibility studies and meets the requirements of low leachables/extractables, low…
IBC’s Fourth Annual BioProcess International Analytical and Quality Summit
The fourth annual BioProcess International Analytical and Quality Summit offers a focused look at solutions and approaches to problems facing analytical scientists in product characterization, assay development, method validation and quality control. Separate conference tracks are dedicated to biophysical analysis, posttranslational modifications, and method validation — with an additional track to tie those fields to the need for improved product understanding associated with quality by design. This multitrack format allows you to customize your conference experience based on your personal…
The Human Network
Biotechnology is not simply about science or technology, process engineering or cell lines, corporations or regulations. It’s ultimately about the people involved in all these things — and about the people they hope to serve with their biotech aspirations. It’s about scientists and technicians, businessmen and medical professionals, patients and consumers, farmers and governments, all their lives touched in one way or another by the biotechnology industry — some admittedly more than others. Policy decisions made by…
Molecular Medicine
In the 1980s biotechnology began to transform medicine with the introduction of recombinant hormone treatments and “magic-bullet†drugs based on monoclonal antibodies. In the 1990s, protein kinases offered a key to cancer treatment, and gene therapies promised to address many diseases at their most basic, genetic level. The 21st Century has brought us stem cells, RNA interference, biomarkers, and predictive medicine. None of these things has supplanted the others; instead, they merely expand on the basic idea…
The Business of Biotech
Calivin Coolidge, who served as president of the United States from 1923 to 1929, is often misquoted as saying “The business of America is business.†According to historians, however, what he really said was, “The chief business of the American people is business.†And he went on in the same speech to say, “Of course, the accumulation of wealth cannot be justified as the chief end of existence.†So the real Coolidge (as opposed to the caricature…
A Vital Link
Clinical studies serve as a bridge between biopharmaceutical laboratories and the patients who need therapies. Drugs need to be tested in small populations before they are made available to the world at large. In a 2006 interview with BioProcess International, editorial advisor Michiel Ultee (vice president of Process Sciences for Laureate Pharma) said, “Until your product is tested in humans — and shown to be safe and to have some efficacy — then you really don’t have…