Unchained Labs floats into LNP production, launches GMP-ready Sunbather!
April 16, 2024 – Pleasanton, CA – Unchained Labs, the life sciences company that’s all about getting biologics and gene therapy researchers the right tool for the job, added a third instrument to its Sunny Suite for lipid nanoparticles (LNPs) today – Sunbather for GMP production of LNPs. Sunbather partners up with its upstream suite members, Sunscreen (formulation screening) and Sunshine (formulation optimization), making it a breeze to rapidly develop LNPs and then transfer their production into GMP.
Scaling up LNPs for clinical trials and commercial use can feel like déjà vu. Switching to more complex equipment that uses a different flow path and mixer means researchers will need to re-optimize and re-validate everything they just figured out in development. Recreating LNPs with the perfect size, encapsulation and stability at a larger scale means using up a bunch more of their precious reagents and blowing through another round of even more expensive single-use consumables.
Sunbather lets researchers scale-up their LNPs without the painful do over. The protocols and mixing methods developed on a Sunscreen or Sunshine can be directly transferred to Sunbather, creating the same, high quality LNPs from system to system. All three systems use the same pumps, multi-use microfluidic mixers called Sunnies and offer in-line dilution. Sunbather adds on GMP-readiness with all the supporting documentation, a fully replaceable flow path and produces up to 1.8 liters per hour.
“Sunbather not only produces liters of stellar LNPs, it’s backed by our Quality Management System (QMS), has 21 CFR Part 11 compliant software and we provide full traceability of wetted materials and extractables data,” said Taegen Clary, SVP of Marketing at Unchained Labs. “With the Sunny Suite, making the move from LNP development to GMP is now a walk in the park.”
About Unchained Labs
Here’s the deal. We’re all about helping biologics and gene therapy researchers break free from tools that just don’t cut it. Unleashing problem-tackling solutions that make a huge difference in the real science they do every day. That’s our mantra, our promise and we own it. We’re located in Pleasanton, CA and can be found online at www.unchainedlabs.com.
Contact:
Taegen Clary
SVP of Marketing, Unchained Labs
[email protected]
925.587.9806