Pharmaceutical developers must possess the necessary skills to create a reliable production process, optimize their therapeutic scale-up, and navigate complex regulatory frameworks to make a novel drug candidate market-ready.
Due to their prior experience, large pharmaceutical corporations may have the internal capacity for several facets of drug research and production. Such businesses would look outside for expertise for particular stages that their internal resources might be unable to assist.
On the other hand, small and fledgling biotechs with limited resources and time frequently collaborate with CDMOs throughout the whole drug research and manufacturing process. Depending on the sort of product or the stage a company is in with its drug—from preclinical to clinical to commercial—external expertise may be sought.
Reasons to Outsource Production to CDMO
To benefit from their proficiency in process development, optimization, scale-up, and CDMO cell therapy, biotech companies collaborate with contract development and manufacturing organizations (CDMOs).
The main causes of biotechs outsourcing to a CDMO were recently revealed by a survey conducted by Merck across more than 50 biopharmaceutical companies worldwide, with 80% of responses coming from small to mid-sized businesses.
Risk reduction, speed, and end-to-end capabilities dominated more than 50% of the survey responses as advantages of outsourcing drug development and manufacturing at preclinical to clinical stages.
Finding production pathway shortcuts to accelerate the process without compromising drug safety falls to CDMOs when hired to optimize process development and scale-up. This is where decisions that reduce process or company risks through risk mitigation come into play.
The second most important justification for seeking outside assistance during the preclinical and clinical stages, according to 16% of the companies surveyed, is to ensure quick preclinical development and scale-up.
The main topic of conversation is still sped. Outsourcing has as one of its main objectives to speed up the process. Particularly during this pandemic, when many clients want to launch new treatments on the market quickly.
Comprehensive Skills and Abilities
Access to a larger pool of resources and abilities is the third key justification for outsourcing, which was cited as crucial by 15% and 16% of respondents for the preclinical and clinical phases, respectively.
A single-source CDMO to help biotechs with small teams navigate the numerous development, optimization, scale-up, validation, and commercialization stages can be a huge benefit. This may save time and resources that would otherwise be used to identify potential partners and coordinate the interests of numerous stakeholders from various organizations.
A CDMO’s prior experience directly feeds into risk analysis, enabling swift and accurate decision-making over time.
Cell therapy businesses are required to make these life-saving medicines more widely available due to the growing importance of cell therapies, such as stem cells and CAR-T, in the fight against cancer over the past few decades. Since they may now be specifically tailored to a person and that person’s cancer, cell therapies have grown more individualized. Healthcare’s wave of the future is personalized medicine.