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A GMP Biotech Production Cleanroom
This Canadian pre-clinical stage pharmaceutical company needed a new cleanroom environment for upscaling the production of its unique vaccine platform. The cleanroom is built to comply with Good Manufacturing Practices (cGMP) and is divided into 3 zones.
The 3 areas are either Grade B, Grade C, and Grade D according to GMP requirements, which can be translated to ISO 7 and ISO 8 cleanroom spaces under the ISO cleanroom regulations.
The nearly 1 000 square feet cleanroom includes Mecart’s custom HVAC system to obtain the required cleanliness levels. The cleanroom panels are also designed for utilities and services integration (water, air, electricity, …)
A summary of the project:
- Pre-clinical stage pharmaceutical company
- Production and analytic suite
- cGMP (Grade B, C, and D)
- ISO 7 & ISO 8
- 1 000 sq.ft.
- Custom HVAC
Developing Personalized Allergen-Specific Treatment
More than 50 million Americans suffer from allergies every year, from minor allergic rhinitis (hay fever) to life-threatening anaphylactic shock. Allergies cost billions of dollars every year for treating symptoms, and the desensitization protocol is a long process that spans over 3 to 5 years with mixed results.
Biotech companies work on delivering a lasting and permanent solution thanks to allergy immunotherapy treatments. This client provides a unique vaccine platform that emerges from synthetic biology. Their self-adjuvant vector has shown promise in the preclinical stage and has exhibited the possibility of overturning allergy symptoms and side effects.
A promising vaccine platform
What started as a vaccine platform for curing allergies could be used to treat other diseases. The vaccine platform could find other applications such as delivering therapeutics in oncology for cancer treatment, supporting immunization efforts against infectious diseases and treating multiple autoimmune disorders.
GMP cleanroom for manufacturing biotech products
Biotechnology companies must meet current Good Manufacturing Practices (cGMP) to ensure quality and safety for consumers. Maintenance and calibration of the equipment, employees with proper qualifications, and most importantly, the cleanroom facility construction and activities must all be conducted under the cGMP guidelines.
Biotech products need to be sterile to be administered to the patients, and contamination would be a catastrophe, business-wise. There are many things to consider when choosing a cleanroom provider. For example, if you think about the GMP requirements and cleanliness level, here are a few things to think about:
- Quality of wall panels: some chemicals and cleanroom disinfectants can be tough and corrosive on paint and material.
- Flush finish: Smooth and impervious surfaces. This means no room for airborne particles to embed themselves in the crevices. Also, easier to wash.
- HVAC systems and AHU unit: This is the heart of the cleanroom environment. Talk with knowledgeable people and experts may help you save on energy costs.
If you want to learn more about designing a biotech cGMP cleanroom, you can look at our articles: designing a cGMP cleanroom for cell and gene therapy or our cleanroom design checklist.
