Genetic Engineering & Biotechnology News

MAY15 2016

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8 | MAY 15, 2016 | GENengnews.com | Genetic Engineering & Biotechnology News Gail Dutton British-based Abzena has acquired two com- panies in the past year, expanding its previ- ously specialized offering to support biolog- ics development from early stages through manufacturing. "Rather than being a generic service pro- vider, like many CROs, we differentiate our offerings. Our partners can select the product to develop, or develop better products based on improvements we can make on the struc- tural side," John Burt, D.Phil, CEO, says. Abzena's strength, to paraphrase the old BASF commercial, is that it makes products better. As Dr. Burt says, "We're the leader in immunogenicity assessments and are ex- panding that offering to answer more of the questions surrounding the response of the human immune system to therapeutic prod- ucts. We're developing a better understand- ing of the positive activity expected with products that enhance the immune response while also understanding the risks associated with their development. "Such assessments help developers under- stand whether their products have the poten- tial to generate unwanted immune responses or antidrug antibodies," Dr. Burt says. Abzena then can remove or reduce that risk through reengineering the protein. Abzena focuses on developing biologics and several of its partners have antibody drug conjugate (ADC) projects in develop- ment. Companies typically approach Abzena during lead selection. For example, for ADC projects, Abzena may develop a range of potential payloads or evaluate conjugation chemistries to select the lead compound. "We work with our part- ners to carry the lead candidate into cell-line development and GMP manufacturing as they move product through the clinic," Dr. Burt says. "Interest in ADCs is increasing, not only for oncology, but also for other indications. We're pushing the boundaries. Therapeutic small molecules are being attached to an- tibodies or other targeting scaffolds such as proteins or peptides," he adds. Acquisitions Added Capabilities Recent acquisitions have broadened the company's capabilities into the manufac- ture of biologics and ADCs, enabling part- ner projects to progress further through the R&D process. "We recognize there are many contribut- ing processes and technologies in the develop- ment of biologics. That's why we've assem- bled the companies we have," Dr. Burt ex- plains. "It ultimately clears the way to expand our offerings, giving our partners the tools to select and develop the best possible products and then have them manufactured." Abzena acquired PacifcGMP in Septem- ber 2015. "This CMO is founded on WAVE disposable manufacturing technology," Dr. Burt elaborates. "Acquiring it gave us GMP manufacturing capabilities. PacifcGMP is our major footprint in the U.S. and led to the acquisition of TCRS," which allowed Abzena to provide the next step in ADC development. TCRS, "The Chemistry Research Solu- tion," is a contract research and manufac- turing company. Acquired December 2015, it adds chemistry services to develop linkers and payloads and produce ADCs, thanks to its expertise in bioconjugation and synthetic organic chemistry. PacifcGMP and TCRS augment the ca- pabilities of the other companies in the Abze- na group. These are Antitope, which focuses on immunogenicity assessments, protein engineering, and cell-line development and PolyTherics, which focuses on conjugation technologies to develop ADCs and optimize pharmacokinetics and pharmacodynamics. Combining the capabilities of these com- panies into one, as Abzena, offers partners an integrated service that uses protein engi- neering to reduce the chance that therapeutic proteins will produce unwanted immune re- sponses. It includes development of a manu- facturing cell line and the actual manufactur- ing of the product for clinical trials. "If you put all that together, we can go from bench to clinical development in the biologics space with a particular focus on the product itself, whether it's clinical or pre- clinical, rather than the in vivo side of the process," Dr. Burt says. Coming Soon: One Company, One Name Abzena is in the process of integrating its many companies into a single, seamless Building a Biologics Capabilities Network CORPORATE PROFILE > BioTek and MilliporeSigma Pursue Joint Effort on Live-Cell Experiments BioTek Instruments and MilliporeSig- ma have agreed to collaborate an inte- grated solution for long-term live-cell experiments and dynamic time-lapse analyses. The companies will focus on automated cell perfusion and imaging. Both companies ofer relevant tech- nologies. For example, BioTek expects to utilize its Lionheart™ FX Automated Live Cell Imager; MilliporeSigma, its new CellASIC® ONIX2 Microfuidic Sys- tem. The Biotek instrument is optimized for quick image capture, analysis, and annotation, as well as time-lapse video production. The MilliporeSigma system automates the control of environmen- tal conditions. > PerkinElmer and GIS Collaborate on Oncology Research PerkinElmer and the Genome Insti- tute of Singapore (GIS) have opened the PerkinElmer-GIS Centre for Preci- sion Oncology. The initative combines PerkinElmer's cell-based imaging tech- nologies with GIS' expertise in cancer therapeutics, stratifed oncology, and regenerative medicine. The collabora- tors will focus on high-throughput screening, the development of bio- markers for patient stratifcation, and the generation of mutational insights . > Parexel and EMC Ally to Provide Information Management Services Parexel International and EMC have formed an alliance to provide cloud- based document and regulatory in- formation management services. The companies will ofer end-to-end Regu- latory Information Management and Regulatory Content Management. These services will be available through the Parexel's Regulatory Cloud, and they will be supported by the Par- exel® Liquent InSight® Regulatory Infor- mation Management platform and the EMC® Documentum® software solution. With these services, clients can support strategy and planning, authoring, pub- lishing, submitting, viewing, archiving, and product lifecycle management functions . n News Products & Services Through a Slew of Acquisitions, Abzena Is Hoping to Become a One-Stop Shop Abzena Location Babraham Research Campus Babraham, Cambridge, U.K. Phone 44 1223 903498 Website www.abzena.com Principal John Burt, D. Phil CEO Number of Employees 180 Focus Abzena is a contract research and manufacturing organization focusing on biologics, including antibody drug conjugates and biosimilars. Vital Signs Abzena has expanded its capabilities by acquiring companies with complementary expertise. For example, the company acquired Antitope, which specializes in immunogenicity assessment, protein engineering, and cell-line engineering. Abzena is also integrating expertise in antibody drug conjugate (ADC) development and GMP manufacturing. The company asserts that it can identify or create the best drug candidates for its partners to develop.

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