Advanced Frameworks for Process and Analytical Technology Transfer

• Quality by Design (QbD): With our extensive process and product understanding, we apply the principles of QbD to ensure the highest possible outcomes for each product, reducing the risks during tech transfer.
• Our team as an extension of yours: Communication is key for successful tech transfers.
  • At Andelyn we work as One Team™ with clients, regularly workshopping process flows, control strategies and success criteria throughout the tech transfer process.
  • Direct discussions with our SMEs and MSAT group enable streamlined and beneficial interactions between scientists.
  • Our highly interactive transfer process including hands-on demonstrations, shadowing, rigorous training, constant feedback loops and person in plant.

Supporting Clients through Analytical Comparability

A clear path for establishing comparability is needed to facilitate tech transfer processes and the ability to successfully execute comparability exercises is critical. Comparability strategies are tailored to each program and product type; at Andelyn, we follow a step-wise approach, starting by identifying product attributes that need to be assessed. We work collaboratively with our clients to draft the analytical comparability protocol and acceptance criteria based on program needs and execute the protocol leveraging Andelyn's extensive analytical capabilities.

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Flexible Facility Design for Smooth Tech Transfers

• Our Development Center is equipped with the same manufacturing equipment and analytical instruments as our Corporate Center for initial proof of concept, engineering and training runs to enable a smooth transfer into GMP production.
• Our GMP vector facility, the ACC (Andelyn Corporate Center), was designed to enable easy reconfiguration in order to accommodate different processes and modalities. For example, all clean rooms have dedicated air handlers, operating as standalone units, and each suite is large enough to accommodate up to 2,000L bioreactors. This flexible design reduces the need for extensive facility modifications during tech transfer, shortening tech transfer timelines, driving costs down, and enabling our Client's roadmap from preclinical to commercial.