As we noted in Part 1 of this two-part article, many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies. In this installment, we will look at the basic design aspects to consider when renovating a facility to meet the unique demands of these therapies without compromising quality.
Modern cell therapy and biotech facilities have many basic requirements for continuous operation that need to be built into a robust facility. With future cell therapy and protein production, we are faced with small volumes, smaller working systems, higher value product, and potentially highly infectious materials.
The key consideration in any modern renovation is planning a space that accommodates the ICH/PICS guidelines, EU Annexes 1 and 2, and the FDA’s CFR 211. Due to the wide range of therapies, viral vectors, and bacterial organisms, the CDC’s guidelines for biosafety levels 1 and 2 (BL-1 and BL-2) and corresponding NIH design guides may also apply.
Ultimately, this leads us to a few basic concepts:
- Large open processing suites with ample room to move processing skids in and out, as well as isolator systems for various cell processing
- Space to stage volumes of disposables
- Unidirectional flow of all personnel, materials, equipment, production, and waste
- Segregation of all processing suites by air handling unit (AHU) to provide a robust facility
- AHU zoning to contain any contamination within the suites
- Air pressurization schemes in suites to contain BL-2 materials
Read the full article on CellAndGene.com.