Establishing Turnkey Tech Transfer Processes For Drug Product

The COVID-19 pandemic impacted nearly all global businesses, but its impact on the biopharmaceutical industry has been particularly severe. In addition to disrupting clinical trials and complicating the logistics of day-to-day operations, the pandemic has driven unprecedented demand for drug product as sponsors and their CDMO partners strive to accomplish no less than vaccinating and curing the world’s population.

The rush to produce billions of treatments and vaccine doses as fast as possible has challenged the capacity of an industry that, even before the pandemic, sometimes struggled to meet demand. Now, as the world emerges from the pandemic, COVID-19 products — combined with therapies delayed by the pandemic and new drugs that have progressed through development in the interim — are competing for global aseptic fill/finish capacity. However, as biotech/biopharma organizations scramble to lock up DP manufacturing partners, they must not lose sight of the vital processes that drive safe DP manufacture, including adept QC testing, batch release testing, studies, and regulatory support.

A well-planned tech transfer is vital for the DP manufacturing process to start off on the right foot. CDMO clients depend on a thorough, efficient tech transfer process that ensures every sequence is faithfully replicated, product quality remains high and consistent, and regulatory obligations are met. It is not enough to boast high capacity — a CDMO partner should drive its clients’ development and commercialization efforts through a diverse toolkit and operational agility, accommodating projects of varying scale with speed and diligence in ensuring a sterile final product.