Cell and Gene Therapies
Novel process development | safe, pure, potent, stable | AAV vectors, lentivirus, adenovirus | key manufacturability gaps | transfer to constrained manufacturing suites | game changer for cell and gene therapy
Cell and gene therapies require novel process development and manufacturing strategies to deliver on their revolutionary promise. These advanced therapeutics require you to develop processes that deliver a safe, pure, potent, and stable medicine, as guided by the FDA, with a manufacturing control strategy that can ensure high-quality delivery to patients over the product lifecycle.
We deploy our upstream, downstream, and analytical expertise across AAV vectors, lentivirus, and adenovirus systems on various host cell platforms, to baseline, optimize and then transfer processes to cell and gene manufacturing suites. We identify key manufacturability gaps early in our collaborations and define and execute a development program that will improve processes and deliver the critical quality attributes required.
We also leverage our 500L pilot plant facility to conduct training runs that build process understanding at scale and support effective and on-time tech transfer into constrained cell and gene manufacturing slots. Our collaborative approach, where we share every data point with you, is a game-changer helping you to take control of your cell and gene therapy development and manufacturing programs.