Alpha Teknova, Inc. (“Teknova”), a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, introduced the Fill-Tek™ Dispensing System. Fill-Tek is a proprietary single-use bag dispensing capability that fills an entire custom reagent order across multiple bag sizes and quantities as a single lot. The Fill-Tek system removes the per-bag-size minimums that come with fixed manifold designs, so manufacturers can order the formats their process calls for rather than the formats the fill line requires.

With the Fill-Tek Dispensing System, customers can simply specify the various bag sizes and quantities across formats ranging from 250 mL to 200 L single-use bags, and then tailor fill volume, number, size, and sequence of QC samples, testing requirements, and connectors. Fill-Tek uses validated aseptic welds to connect the customer’s specific combination of single-use bags to a dispensing vessel so they can be filled from a single batch through a single filter, resulting in one Certificate of Analysis for each lot.

“The bioprocessing workflows and manufacturing requirements for novel therapeutics and diagnostics are complex and dynamic, and we’re committed to finding better ways to streamline and support them. Fill-Tek operates by formulating and dispensing from one batch vessel through one filter into the exact configurations that a customer may need, including a variety of bag sizes with different fill volumes, or even a single bag,” said Bella Neufeld, Teknova’s Vice President of Operations. “With Fill-Tek, we simplify incoming quality control requirements, enable the use of the same reagent in different volumes at different workflow stages, and minimize rework by attaching the right connectors onto the bags so they seamlessly integrate into an existing bioprocessing system.”

Fill-Tek runs in Teknova’s ISO-classified cleanrooms as part of the Company’s validated aseptic dispensing process, backed by its ISO 13485:2016 certified quality management system. The capability is available across Teknova’s RUO, RUO+, and GMP manufacturing grades, with batch volumes that start from eight liters for custom research-grade orders and 25 liters for GMP-grade orders, scaling up to 2,000 liters – all with no change to Teknova’s industry-leading turnaround times.