In this blog post, our Regulatory Governance & Assurance Manager, Joan Benson, gives a history on the development of the Cell & Gene Therapy sector and the settings needed for the various processes.
Historically cell lines were used in the pharmaceutical industry for the development of biologic drugs, with the first synthetic insulin being developed in 1978. Since then, the cell and gene therapy field has expanded massively, driving the need to meet ever increasing requirements. However this is still a new and emerging industry requiring innovative approaches and development/optimisation of processes.
For research purposes only, a laboratory setting is suitable for cell culture but once cells are being derived, cultured and banked for a potential human application, this must take place in a controlled, regulated environment with cell and gene therapy manufacturing equipment. In the UK, regulators may include the Human Tissue Authority (HTA) the Medicines and Healthcare products Regulatory Agency (MHRA) and/or the Human Fertilisation and Embryology Authority (HFEA). Any cleanroom and equipment must meet the regulatory requirements.
Growth in the field of Regenerative Medicine, Tissue Engineering and the search for treatments for rare diseases has led to translational facilities in universities bridging the “Bench to Bedside” gap for new drug development for cell and gene therapy products. Laboratory researchers are able to translate their laboratory work into an Advanced Therapy Medicinal Product (ATMP) early phase clinical trial, using technology transfer and scale up, in their own laboratory, then an academic or linked hospital cleanroom. If early phase clinical trial results are positive, they can then hopefully go on to develop a successful therapy via a spin off company or a pharmaceutical partner.
The development of gene therapies may also require the support of regulated, specialist cleanrooms to produce the viral vectors used to genetically modify cells. Other products used in the treatments, e.g. cell media and supplements, and consumables may also need to be manufactured in GMP or ISO cleanrooms.
Cleanroom conditions for cell culture
Across the cell and gene sector there is a clear requirement for the development of cleanrooms to support growth. The design of these cleanrooms must consider: the processes to be used in manufacture, equipment that will be required (i.e. cryogenic transport for cell and gene therapy products), personnel and material flow, environmental conditions required and scope for future expansion.
Connect 2 Cleanrooms has supported the Cell and Gene sector with GMP cleanrooms and was the Principal Contractor on a new ATMP manufacturing facility for RoslinCT.
This blog was first published on our UK website.