Quality

We focus on every aspect of quality control to advance your product through clinical milestones as quickly and safely as possible. We understand that quality assurance is key to laying a solid foundation for each therapy in the clinic.

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People

Our dedicated quality assurance (QA) team is integrated into manufacturing processes and all our technicians are trained by quality experts. Our QA team operates independently and report directly to our CEO.

Culture and training

  • Quality-centric culture
  • All personnel receive training in quality

Quality Software & Controls

Robust controls are in place to ensure your products are delivered with the highest quality and safety. Our quality management system provides enhanced document management and electronic change control capability which strengthens compliance and decision-making.

Quality software

  • Veeva QMS
  • Phase appropriate QA systems

Quality controls

  • Established quality control methods including plaque/viral/titer
  • CAPA and change control system

Biological Assays

We develop tailored biological assays to better control and assure the quality of your products including:

  • Stability program
  • Sterility program
  • Viral vector release testing
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Regulatory Compliance Profile

  • FDA Guidance Phase 1 Investigational Products
  • cGMP for Pharmaceuticals (21 CFR 210 & 211)
  • USP/NF Chapter <1047> Gene Therapy Products
  • ISO 14644:2015 Cleanroom Design and Control
  • EU GMP Annex 1: Manufacture of Sterile Medicinal Products 2020
  • ICH Guidelines Q2(R1) Validation of Analytical Procedures

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Meet our People

Our team is dedicated to getting your viral vector where it needs to go. Communication and collaboration are part of our DNA and we can't wait to talk to you about your current challenges and needs.

Brok Weichbrodt

VP of Operations

Pratima Cherukuri

Chief Scientific Officer

Ray Kaczmarek

Chief Executive Officer