Genetic Engineering & Biotechnology News

MAY1 2015

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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24 | MAY 1, 2015 | | Genetic Engineering & Biotechnology News Although reliably achieving the most de- sirable glycoform is an abiding challenge, it never gets old. Investigators are always on the lookout for new solutions. These inves- tigators include Michael Butler, Ph.D., a pro- fessor of animal cell technology at the Uni- versity of Manitoba. "Consistency is the frst concern. Process developers want the glycosylation pattern to be the same from batch to batch," Dr. Butler says. "When that doesn't occur, process developers must relate those batches to what occurred during clinical trials. And next, within that level of consistency, you want the most clini- cally effective form of the antibody depending on the molecular basis of its clinical use." For example, anti-infammatory isoforms may be required for one type of therapy, but they may be unnecessary or even undesirable for others. Higher animals natively generate "designer" glycoforms through polyclonal an- tibody creation, where glycoprofles change ac- cording to in vivo needs. Dr. Butler's discovery relates to levels of nutrients such as glutamine and glucose. In fed-batch cultures, low levels of these sub- strates are preferred because this assures the most effcient energy metabolism and the lowest byproduct or impurity generation. But very low levels, particular for glucose, impinge negatively on the type of glycosylation obtained. This is what Dr. Butler calls "macro heterogeneity," where entire regions on the glycosylation pattern are empty. "You have to Quality, Yield Still Rule Protein Production Q u a l i t y , Y i e l d Quality, Yield > BlueSens and TRACE Launch Network for Bioprocess Analytics BlueSens and TRACE Analytics founded ABS Analytical Bio- process Solutions, a network for bioprocess sensors. The initiative will utilize products from both of the German companies. TRACE is a provider of analytical instruments for online monitoring of cell cultures and fermentation in the liquid phase. BlueSens is a spe- cialist for gas analysis in bioprocessing and also ofers software to monitor bioprocesses. The software collects the measurement data of all sensors and will allow a process control in the future. The network plans to grow and add other companies. > Cobra, Tecrea Awarded Innovate UK Grant to Develop AAV Scalable Production Bioprocess Cobra Biologics, a contract development and manufactur- ing organization that produces biologics and pharmaceuti- cals, and Tecrea, a cell delivery biotechnology company, have been awarded a 15-month collaborative grant of £112,291 (about $166,000) by Innovate UK for the development of a scalable adeno-associated virus (AAV) production bioprocess. The grant was awarded under Innovate UK's Technology In- spired Innovation competition, which aims to stimulate inno- vation within biosciences. The collaboration between Cobra Biologics and Tecrea focuses on the development of a robust, large-scale biopro- cess for AAV production. According to the companies, AAV is a safe and efective gene therapy vector. They add that grow- ing commercial demand for AAV cannot be met by current, nonscalable production approaches. The new system aims to achieve scalable GMP production of AAV at low cost by combining NanoCargo™, a low-toxicity nanoparticle-based transfection system from Tecrea, with Cobra's small footprint hollow fber bioreactors and manufacturing expertise. > Pall Acquires BioSMB Technology from Tarpon Pall has acquired the BioSMB® technology platform from Tarpon Biosystems to expand its downstream continuous processing capabilities. The technology consists of chromato- graphic systems that enable single-use, multicolumn chroma- tography for process development. They can be applied to multiproduct and single-use facilities, and they complement the existing Allegro™ portfolio of products. The BioSMB technology is fully scalable from process de- velopment to large-scale GMP production. The disposable fow path features an integrated valve cassette and services up to 16 columns or devices. BioSMB incorporates disposable components to allow for fexible, multiproduct biomanufac- turing while reducing costs. > AMRI Decides to Shut Down API Manufacturing Facility Ofcials at AMRI said they will close the Holywell, U.K. facility by the end of the year. The site provides chemical development services and small- and large scale-manufacturing services of active pharmaceutical ingredients (API) and intermediates. "This was a difcult decision as it impacts team members who have made valuable contributions to AMRI," noted Wil- liam S. Marth, AMRI's president and CEO. "We will work dili- gently to ensure the closing of the Holywell facility goes as smoothly as possible for our customers and employees." AMRI will transition activities at the Holywell site to other facilities within the AMRI network. Closure of the site is ex- pected to afect approximately 62 positions. > Onyx Scientifc Expands GMP Capabilities UK-based Onyx Scientifc reports that it will invest in growing its small-scale API manufacturing services. Company ofcials say the move will see the installation of a new Class 100,000 suite at its facility in North East England aimed at satisfying an upsurge in Phase I/II GMP campaigns from clients in Europe and the U.S. The company specializes in preclinical/clinical develop- ment projects. The CRO provides clients with the production of API up to 50L-100L under current GMP regulations, which dovetails its earlier-stage custom synthesis, lead optimization, solid-state and analytical services. "By having an additional GMP suite at our disposal, it gives us even greater fexibility to assist our clients that are under increasing timeline pressure to deliver against their develop- ment programs," explained Denise Bowser, the company's commercial director n News BIOPROCESSING Scientists at the University of Manitoba examined two monoclonal antibodies and found diferences in their glycan profles. EG2, a chimeric llama-human antibody, was shown to have specifcity to EGFR; DP12, a humanized antibody, specifcity to IL-8. Both were produced from CHO cells grown in the same serum-free media (Biogro). (For details, see J. Biotechnol. 2014. Jan. 20; 170: 17–27.) See Protein Production on page 26 Angelo DePalma, Ph.D. Uniformity is king when it comes to glycoforms. Once the most effective, least immunogenic form is identifed, bio- processors seek processes that replicate this molecule with- in reasonable boundaries—the exclusion of fucosylation, maximum galactosylation, or specifc sialylation patterns.

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