BioPharm International - November 2022

BioPharm International - November 2022

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22 BioPharm International ® Manufacturing and Facilities 2022 eBook T he pharmaceutical industry continues to exponentially increase as new methods and technology become a launchpad for inno- vations, especially within the cell and gene therapy industry. According to a Pharmaceutical Research and Manufacturers of America (PhRMA) report (1), it takes, on average, 10–15 years and costs roughly $2.6 billion for a new drug to go from dis- covery to market. PhRMA also reported that 74% of clinical development are new approaches to treating disease across what is currently in the pipeline. Addi- tionally, scientists and researchers are leaning toward a tailored approach to personalized medicine. FDA has predicted that by 2025 they will approve between 10–20 cell and gene therapy products per year (2). Traditional ways of looking at the discovery and development of pharmaceutical and biopharmaceuti- cal products, therapies, and treatments are not meet- ing the industry's demand. As new approaches are being researched, conventional wisdom has forced biopharma companies to choose between two op- tions in developing products: either build their own facilities, which can take years and cost millions, or outsource to contract manufacturing organizations (CMOs)/contract development and manufacturing or- ganizations (CDMOs), which, especially in the wake of COVID-19, are facing years of backlogs. To solve t h is manufact urer's di lem ma, compa- nies are considering an innovative way to acceler- ate the development of pharmaceutica ls and bio- t herapeut ics— clea n room l icen si ng. Clea n room licensing is a hybrid approach between do-it-your- sel f (DI Y) a nd out sou rci ng to a CMO/CDMO t hat gives early phase or startup bio/pharma companies the opportunit y to achieve their goals in a shorter timef rame t han anticipated. T h is ar ticle w i l l ex- plore the benefits and challenges that companies, especia l ly ea rly sta r t ups, face i n ma nufact ur i ng a nd how c lea n room l icen si ng put s t hem on t he path from discover y to deliver y. Threading the Needle Between DIY and CDMO Ravi Samavedam is chief innovation officer at Azzur Group. In the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing. ALEX ANDR - STOCK.ADOBE.COM

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