Early Adoption of Technologies Key to Biologics API Success

Contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) must introduce novel technologies early in the cell line development and production processes to stay on top over competitors in the market, says leading data and analytics company GlobalData. New techniques for developing and producing cell lines and gene editing are a focus within the biologics industry. With the recent boom in cell and gene therapies, gene-editing technology has become a critical part of biologics manufacture. For example, clustered regularly interspaced short palindromic repeats (CRISPR) are now viewed as one of the production technologies and key to the future of developing new cell therapies. Some companies have already been investing in CRISPR technologies. Last year, for instance, UK-based Horizon Discovery began offering CRISPR, along with other gene and cell therapy technologies, for contract services. Germany-based Evotec acquired UK-based preclinical CRO Cyprotex to gain phenotypic screening platforms for use with genome editing technologies such as CRISPR and short hairpin ribonucleic acid (shRNA) in January 2017.

Peter Shapiro, Editor in Chief of   the GlobalData product PharmSource, says, “Other gene-editing techniques, such as recombinant adeno-associated virus (rAAV) and Transposon technologies may also see increased use as the biologics industry moves forward into new types of cell-based products. Additionally, companies are looking to metabolomics to better understand the cells they are working with to develop more highly customized media, use genetically modified yeast hosts in the development production of recombinant proteins, and adapt bacterial techniques to mammalian cell production.” At the recently held Biotechnology Innovation Organization (BIO) meeting in Boston, industry experts discussed the options available to large molecule active pharmaceutical ingredient (API) manufacturers, including CMOs and CDMOs, for speeding the entry of quality products onto the market.

Speaking at the meeting, Rajesh Beri, Technical Director of Bio-manufacturing, Research and Technology at Switzerland-based Lonza, said that the best time to implement new technologies is early in process development or when constructing a new facility. Chris Love, a professor at the Massachusetts Institute of Technology in Cambridge, said that future technologies will blur the lines between strain and process engineering, as production processes for new biologics are often highly dependent on the exact cell lines being used. Shapiro concludes, “For this reason, many biologics API manufacturers such as Abzena, AGC Biologics, Paragon Bioservices and WuXi Biologics have been embracing single-use manufacturing technology, which allows greater process flexibility between product lines.” – Medical Buyer Bureau