By Tom Ballard, Chief Alliance Officer, PYA
Graham Taylor has announced the founding of Helix Biotech Inc., a customer- and quality-focused contract development manufacturing organization (CDMO) specializing in lipid nanoparticles (LNPs), liposomes, and hybrid nanoparticles.
Officially launched May 18, the start-up has leased 2,000 square feet of lab and R&D space in a building that was part of the former Regal Headquarters campus in North Knoxville. Taylor told us in a recent interview that the new venture includes himself and two other employees with plans to scale-up to about 10 people within the next few months.
“Within five to six months, we will have acquired an additional facility and established cleanroom capacity dedicated for GMP (good manufacturing practices) operations,” he added. “Our expertise is in the CDMO space.”
The primary customer is the pharmaceutical industry, specifically serving those companies conducting pre-clinical development and Phase I and Phase II clinical trials. That’s a sector that Taylor knows well from his tenure with two companies – Medtronic Spine & Biologics and later Merit Medical Systems Inc. – and for nearly seven years as Co-Founder, President and Chief Technology Officer at T&T Scientific Corporation, another Knoxville biotech start-up.
“We offer both products and services,” Taylor (pictured right) says of the new company, reinforcing Helix Biotech’s mission to bring value to the world through innovative products and world-class services that accelerate the development and commercialization of life-changing therapeutics and vaccines.
Among the services that Helix Biotech provides are these:
- Formulation development and screening including: (1) sample preparation and analysis; (2) formulation selection and design; and (3) optimization by design of experiments
- GMP process development to include manufacturing process design, feasibility, and implementation.
- GMP analytical method development including compendial analytical methods and custom analytical methods, from method feasibility to full validation.
- GMP manufacturing including: (1) batch production, lot release; (2) aseptic fill/finish (i.e., sterile glass injection vials); (3) clean and sterile processing rooms; (4) tech transfer or in house development; (5) qualified temperature-controlled storage and stability programs; and (6) compliance with 21 CFR Part 210/211.
“We will place a great deal of emphasis on employee training, then delegation of responsibilities and the autonomy to execute,” Taylor says.
The Chattanooga native earned his B.S. in Biomedical Engineering from the University of Tennessee, Knoxville in 2007, then returned to earn his Ph.D. in the same field in 2016.