BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

Issue link:

Contents of this Issue


Page 16 of 39

16 BioPharm International eBook May 2021 Sharing the same values S u s t a i n a bi l it y prog r a ms a re f u r- ther transforming the industr y and b e st pr ac t ice s. A s det a i le d here , the long-term v ision and underly- ing 3R principles (specifically, refine, replace, and reduce animal testing) play a critical role in the evolution of biologics manufacturing and test- ing (13). Technologies such as NGS that further enable more sustainable testing continue to evolve and gain acceptance, and are well poised for the future. CONCLUSION The f ield of v ira l safet y continues to be a particularly active one, with NGS-based tests driving a shift in the way viral testing is perceived and performed. There are a willingness and a necessity for both manufactur- ers and viral safet y testing provid- ers to collaborate in a way that takes full advantage of NGS-based tests and similar technologies. While the COV ID-19 outbreak has been dev- astating in its impact on the world and human health, it has also had a positive inf luence on the rapid devel- opment of therapeutics and the adop- tion of alternative manufacturing and testing technologies such as NGS. Moreover, regulator y agencies have taken notice and are now accepting and even recommending, on a case- by-case basis, NGS-based tests. As NGS-based tests are rapidly evolv- ing, technological advances such as machine learning and artificial intel- ligence should make them even more robust, time-saving, and cost-effective than they already are, and has opened a new window into the future of bio- safety assurance. REFERENCES 1. Reports and Data, "Biological Safety Testing Market By Product (Reagents & Kits, Instruments, Services), by Application (Vaccines & Therapeutics, Stem Cell, Tissue & Tissue-Based Products, Gene Therapy, Blood & Blood-Based Therapy), by Test Type, and Segment Forecasts to 2027," Market Research Report, www., July 28, 2020. 2. J.G. Victoria, et al., J Virol. 84 (12) 6033–6040 (2010). 3. J. Petricciani, et al., Biologicals 42 (5) 223–36 (2014). 4. ICH, Q5A (R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Step 4 version (1999). 5. P.W. Barone, et al., Nat Biotechnol. 38 (5) 563–572 (2020). 6. FDA, "Historical Case Studies of Biologics Regulation," www.fda. gov, accessed Jan. 23, 2018. 7. E.J. Lefkowitz, et al., Nucleic Acids Research 46 (1) 708-717 (2018). 8. S.J. Anthony, et al., mBio. 4 (5) e00598-13 (2013). 9. V. Bethencourt, Nat Biotechnol. 27 (8) 681 (2009). 10. L. Bush, "Genzyme Detects Virus Contamination of Bioreactor, Halts Production" www.biopharminternational. com, Jun. 17, 2009. 11. M. Plavsic, BioPharm International 29 (5) 40–45 (2016). 12. K.M. Remington and J. Zehmer, BioPharm international 27 (10) 40–47 (2014). 13. EMA, EMA/CHMP/CVMP/JEG- 3Rs/450091/2012, Guideline on the Principles of Regulatory Acceptance of 3Rs (Replacement, Reduction, Refinement) Testing Approaches (Dec. 15, 2016). BP Partnerships for Outsourcing Analytics A new partnership between Waters and Genovis, a US- based enzymes and technologies provider, is expected to accelerate biopharmaceutical characterization work- flows as the partners aim to develop automated work- flows for fast and constant characterization of critical quality attributes of monoclonal antibodies (mAbs) and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control. In April 2021, the companies formed a collaboration to develop and market complete routine biopharmaceutical characterization workflows based on the Waters BioAccord LC–MS System, Andrew+ pipetting robot, and Genovis SmartEnzymes (1). The workflows in development will focus on product variant analysis, bioprocess stability monitoring, and biosimilar glycosylation analysis. "Biologics analysis is an area that is ripe for improvement. What takes analytical scientists several days to do, should take hours or minutes instead," said Jeff Mazzeo, vice- president, Global Marketing and Scientific Operations, Waters Corporation, in a company press release. "Today, up-front sample preparation is a major bottleneck to productivity, largely due to the number of manual steps involved and the outmoded technology by which samples are readied for analysis. By combining Genovis' SmartEnzymes with automation, liquid chromatography/ time-of-flight mass spectrometry, and application- specific software workflows from Waters, we intend to move biotherapeutic analysis forward in ways never thought possible." "The BioAccord LC–MS system and the Andrew+ pipetting robot align perfectly with our strategies and vision at Genovis to bring simplified, robust, and automated enzyme-driven workflows to the biopharma industry," added Fredrik Olsson, CEO, Genovis, in the press release. "The enzymatic workflows that we will develop in collaboration with Waters will help our customers in their efforts to bring safe and novel therapeutics to patients, faster." Reference 1. Waters, "Waters and Genovis Collaborate to Develop Ef- ficient Workflows for Biopharmaceutical Characterization," Press Release, April 13, 2021. —Feliza Mirasol Biopharma characterization partnership accelerates workflow

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - May 2021 - BioPharm - Partnerships for Outsourcing - May 2021