Genetic Engineering & Biotechnology News

MAY15 2017

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 15, 2017 | GENengnews.com | Genetic Engineering & Biotechnology News Formerly known as Celeros Separations, Inc. (Foxborough, MA), Celeros Separations, LLC (Durham, NC) has been acquired by its founder Robert Bret Carr, and is now un- der new ownership and management as of January 2017. Celeros Separations (www. celeros-separations.com) has re-launched and released new line of APD (automatic piston discharge) centrifuges for the biopro- cessing industry. GEN recently interviewed the founder and the inventor of Celeros' APD technolo- gy, Robert Bret Carr, to find out more about Celeros Separations, LLC and its product of- ferings for biomanufacturers. GEN What technologies formed the basis for Celeros' business and marketing strategies? Mr. Carr The Celeros family of APD centri- fuges, which includes the APD-75, APD-125, APD-250, and APD-125 II, are semi-con- tinuous solids-handling high-speed tubular bowl centrifuges. The core technology is the unification of three features in one package: a patented automatic piston discharge (APD) technology, its high-speed separation capabil- ity, and its low-shear mechanism for shear- sensitive materials. APD allows complete transferring of separated solids from the bowl without operator intervention. The narrow geo- metric design of the bowl allows powerful rotational forces from 0–20,000 G, giving centrate clarification and solid isolation. By combining the gentle acceleration of the feed flow, the flooded feed inlet, and submerged centrate outflow, APD minimizes shear to sensitive cells or vaccines. GEN What are the benefits of the APD centrifuge to bioprocessors? Mr. Carr The benefits of the APD centrifuge are focused on minimizing product loss and liquid clarification in a fully contained asep- tic process. The Celeros APD separation system focuses on yield and purity and can provide substantial economic benefits. For recovery of the isolated solids, the APD cen- trifuge enables bioprocessors to collect and discharge up to 99.9+% of biopaste with no manual intervention. For clarification, the power of up to 20,000 G significantly maximizes separa- tion efficiency and recovery of the high val- ue liquid phase. Other benefits include: its low-shear design for fragile cells or sensitive biomolecules, full automation to minimize labor as well as to prevent product contami- nation and associated risks, and its supe- rior clean-in-place (CIP) and steam-in-place (SIP) options. GEN What are some of the main applications of APD centrifuges? Mr. Carr Applying the benefits of gentle ac- celeration and powerful separation, APD centrifuge has been proven compatible with the most challenging separation and clarifi- cation processes that confront the biotech industry. Verified results of independent laboratory and customer reports show the great advantages in applications, including mammalian and bacterial cell harvesting and debris removal, microbial processing (i.e., E. coli, inclusion body recovery, yeast), protein precipitates, vaccine, and blood plasma frac- tionation. It can also be used for specialty polymers and electronic materials for the chemical industry. GEN What will be the focus of Celeros as compared to the original company? Mr. Carr We are transforming Celeros Sepa- rations, LLC into a business that is based on 100% customer satisfaction, parallel to our continuous efforts on product improvement and development. Today, biotech and phar- maceutical process engineers are demand- ing more from their equipment designers. We will not only listen but also fully engage customers, i.e., process engineers, to find the best solutions to achieve their goals. GEN What will differentiate the new line of APD centrifuges that Celeros will be launching from those that were manufactured and marketed by the previous company? Mr. Carr Our APD model of original design is in use at customer installations with good success and reliability. We now have two new products: APD-125 II version 1, which has C.I.P. and S.I.P. capability, and version 2, which has a single-use disposable feature. Both are equipped with the same 20,000 G and process capabilities. Both versions feature a significantly sim- plified mechanical structure that will allow much easier manufacturing and mainte- nance, and exclusion of any liquid/air inter- face to avoid foaming and product oxida- tion, and the same wide range of applica- tions as the previous design. Bioprocessing Perspectives Ce l e r o s S e p a ra t i o n s p r o v i d e s a ra n g e o f centrifuges adaptable to process development laboratories, pilot plants, and production-scale bioprocessing facilities. The centrifuge in this image, the APD-125, has a bowl volume of 5 L and a maximum feed rate of 7.5 L/min. It is built to cGMP standards; can be tailored to meet specific application requirements; and offers scalability from laboratory, prototype, pilot, to small/medium/large production volumes. Automatic Piston Discharge Pushes Ahead Centrifuges from Celeros Separations Discharge Biopaste in a Sealed Environment Insights Bioprocessing Fujifilm said it will increase production capacity by investing about $130 million in the U.S. and U.K. in order to expand the business of its BioCDMO Division. At Fujifilm Diosynth Biotechnologies Texas (FDBT), a $93 million cGMP production facility has been com- pleted. It was built in part with funding from BARDA (Biomedical Advanced Research and Development Au- thority), an office of the U.S. Department of Health and Human Services. Fujifilm plans to invest an additional $28 million to outfit the facility with mammalian cell culture bioreactors. This facility will start operation at the beginning of 2018. In addition, a $9 million investment will be made to expand the process development capabilities at Fujifilm Diosynth Biotechnologies U.K., near to its Billingham, U.K. site. This facility is scheduled to be operational in summer of 2017. The FDBT facility will be the manufacturing center of excellence for the company's Saturn monoclonal antibody platform, with an initial cell-culture capac- ity of 6,000 L (3 x 2,000-L bioreactors). The design of the facility allows for future expansion that can ac- commodate up to 24,000 L of upstream capacity to meet much needed customers' clinical and commercial demands. In the U.K., the investments include the establish- ment of a dedicated Mammalian Cell Culture Center of Excellence. These laboratories span over 10,000 sq. ft. and are designed to incorporate high-throughput tech- nologies, including fully automated bioreactors and chromatography systems, to enable rapid and efficient monoclonal antibody manufacturing process readiness, said Steve Bradshaw, CEO of Fujifilm Diosynth Biotech- nologies, adding that these assets will enable Fujifilm to provide "best in class" facilities, technology, and opera- tional know-how to the industry. "They are also a key in our continuing commit- ment to develop future medical countermeasures and pandemic flu response candidates for our long-term partners the CIADM (Center for Innovation in Advanced Development and Manufacturing), BARDA, and other third-party customers," he pointed out. n Fujifilm Boosts Production Capacity and Sets Up New Process Development Facilities

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