Jakub Čierný
Chief Quality Compliance Officer
Post-Brexit, UK-based biotechs wanting to supply final products into Europe may benefit from the services of an EU-based Contract Development and Manufacturing Organisation (CDMO).
When biotech companies move their cell and gene therapy (CGT) programmes from the lab into clinical development, they may not be considering later-stage challenges. Yet, they’ll save huge amounts of time, trouble and expense if they do, says Jakub Cierny.
Specialist third-party services for cell and gene therapy
Cierny is Chief Quality Compliance Officer at SCTbio, a Prague-based CDMO, offering CGT developers specialised services, including cell therapy manufacturing, quality control, leukapheresis collection and final drug product delivery. “Companies can be so focused on the science that they don’t consider the regulatory hurdles,” he explains.
CDMOs based in Central Europe offer developers significant cost advantages
For example, any UK- or US-based biotech wanting to supply its final products into the EU faces a major compliance obstacle. The post-Brexit regulatory reality means that Qualified Persons (QPs) operating solely under UK authorisation can no longer release therapeutic batches bound for the continent — an EU-based QP is required. Establishing new EU legal entities for import and batch release is costly and complex. A simpler alternative is partnering with an established EU-based CDMO with in-house analytical testing and integrated QP release capabilities.
Significant cost advantages without compromising quality
CDMOs based in Central Europe offer developers significant cost advantages (eg. lower manufacturing costs and GCP-compliant clinical trials up to 70% cheaper than US equivalents) without compromising quality. “All European member states operate under the same European Medicines Agency standards, which are among the most stringent in the world,” says Cierny.
Developers may also choose a CDMO partner deeply connected to the American market, with US Contract Research Organisation (CRO) partners, fully integrated transatlantic logistics and seamless FDA regulatory alignment. “The US is still a huge driver in global cell and gene therapy,” says Cierny.
Seeing the bigger drug development picture can prevent unpleasant, costly and time-consuming surprises. “Being well-prepared is better for the developer and ultimately lowers the impact on the patient,” says Cierny. “And the patient always comes first.”
