I accompanied PROVIREX from the initial idea to the successful implementation of state-of-the-art cleanrooms for ATMP production

Employee training in the cleanroom: Instruction on the CliniMACS Prodigy® and practice of the qualified procedures. (Copyright: io)

Cleanroom with daylight and a view of the city: Employees in full protective gear on their way to the process area. (Copyright: io)

Completed cleanrooms of class C and class B: qualified infrastructure with air technical supply and clear material and personnel routes. (Copyright: io)

Entry lock of the production area: fully protected staff before entering the GMP cleanroom. (Copyright: io)

Instruction and process training on the CliniMACS Prodigy®. (Copyright: io)

Safety and Process Check: Review of work instructions for the lockage process and entry into the S3** area. (Copyright: io)

With the completion of the new cleanrooms for the manufacturing of Advanced Therapy Medicinal Products (ATMP), PROVIREX has achieved a milestone for cell and gene therapy in Germany. io has been on board from the very beginning as a consulting and planning partner – from concept development through planning and implementation to qualification support.

Innovative project for groundbreaking therapies

PROVIREX Genome Editing Therapies GmbH is a highly innovative biotech company specializing in the development of novel gene therapies. The new cleanrooms in TecHHub Hamburg meet the strict requirements of safety level S3** and are GMP-compliant. They enable PROVIREX to apply the proprietary Brec1 technology as a stem cell therapy within the framework of initial clinical trials. The so-called gene scissors Brec1 cut out the blueprint of the AIDS pathogen HIV from the DNA of the infected cell, eliminating the virus. For the first time, it might be possible to remove the virus instead of keeping it in check with antiretroviral therapy, as is common with previous treatment methods.

Additionally, the new cleanrooms at PROVIREX in Germany will soon allow significantly more cancer patients to benefit from CAR-T cancer therapy, including people living with HIV who face difficulties accessing such therapies due to increased safety requirements for laboratories.

Holistic expertise for complex requirements

As an independent consulting and planning company, io accompanied the project through all phases. Starting with feasibility analysis and concept development, through basic and detailed design, up to implementation support and interface coordination at TecHHub. The services included, among others:

– Planning and integration of GMP cleanroom and laboratory areas considering TGA requirements
– Project management and coordination of all trades (HVAC, electrical, MSR) as well as coordination with the client and authorities

A strong signal for the future of gene therapy

"We are proud to have supported PROVIREX in this pioneering project. The new cleanrooms are a decisive step forward in developing innovative therapies against HIV and cancer," explains Dr. Thomas Centner, Principal Consultant at io. "Our interdisciplinary expertise in pharma/biotech, TGA, and architectural planning has contributed to realizing a cleanroom project that meets the highest safety and quality standards and creates one of the most beautiful cleanrooms in Hamburg, where qualified staff find an appealing working environment – unique in Germany."