Akron collaborates with top cell and gene therapy companies to develop safe and efficient cGMP-compliant transfection and transduction reagents
At Akron, we bring more than a decade of experience in the manufacture of custom cGMP-compliant viral transduction enhancers and non-viral transfection reagents and solutions to enable your therapeutic programs’ success.
The successful transfection of nucleic acids into the cytoplasm (during transient transfection), and into the nucleus requires either a physical or chemical-mediated approach to temporary membrane permeabilization. Common approaches include electroporation, sonoporation, lipofection, and microfluidics.
At Akron we develop and manufacture custom transfection reagents under cGMP compliance, targeting several stable cell lines as well as transient transfection. This includes the manufacture of buffers compatible with a range of electroporation, sonoporation, and microfluidics platforms and transfection reagents including lipid nanoparticles (LNPs) that minimize toxicity while ensuring high efficiency and viability.
Transduction is a delivery method which introduces nucleic acids (DNA or RNA) or other particles into the cell via a viral vector carrying the genetic payload across the cell membrane and into the nucleus. The effectiveness of viral gene delivery can be improved through the use of certain small molecules.
There are several FDA-approved small molecules that enhance transduction efficiency. Akron has extensive experience formulating these small molecules into cGMP-compliant reagents, filling into containers in aliquots appropriate for seamless integration into your manufacturing process.
- FLEXIBLE FILLING CAPABILITIES – Manual and semi-automated filling lines to support everything from small-batch production (1L+) to commercial supply (500L)
- SEVERAL MANUFACTURING ENVIRONMENTS – From process development laboratory to several cleanroom suites (ISO 7) with final fill & finish under Laminar Flow (ISO 5)
- VARIOUS CONTAINER OPTIONS – Multiple formats including vials, syringes, bottles, and bags to best integrate with your process
- COMPREHENSIVE DOCUMENTATION – Development of process, testing, and release package in line with cGMP requirements
- REGULATORY SUPPORT – Experience with regulatory agencies in the US, Europe, and Japan to ensure compliance and support filings
At Akron, our approach to developing novel transfection & transduction reagents is to establish a strong foundation through extensive investigation and optimization, enabling a seamless transition to large scale production of high quality reagents.
Contact our team of experts today to discuss your custom project requirements.