Scientists around the world are focusing their energy and resources on translating advances made in clinical research into relevant biotechnology, clinical, and applied products that improve our health and well‐being. Once research looks promising, there is substantial pressure to expedite the release of that product or assay in the market. For many organizations focused on developing these advanced products, their expertise and core competencies are in developing the assay. Often, they do not have the experience, infrastructure, or quality systems in place to support large‐scale production, packaging, or distribution of their newly developed assay in a way that is also in compliance with relevant regulatory requirements. These next steps become a barrier to realizing the value of the research. Working with a custom or contract manufacturing partner can lower this barrier and expedite the time to market.
Be careful not to confuse custom manufacturing with original equipment manufacturer (OEM) products. OEM products are existing products from one company that another company rebrands and sells. Custom manufacturers typically focus on providing more comprehensive services that can be adapted to produce a new product. Custom manufacturing is not “one size fits all” and can be simple or complex, such as producing a single component to a final finished product.