At AiX, we leverage our extensive knowledge and experience in the design and execution of biopharmaceutical facilities. Our capabilities encompass a wide array of crucial elements, including process design, batch sizing calculations, risk analysis (FMEA) associated with upstream, downstream and fill, finish & packaging requirements along with in depth knowledge of personnel & process flows, air classification, air cleanliness, biosafety levels, and other major engineering insights to design state-of-the-art bio-pharmaceutical facilities.

Our commitment to excellence extends to adhering to the standards set by regulatory bodies such as the US FDA, UK MHRA, EU GMP, WHO, and more. From conceptual design, inventory management, and logistics planning to commissioning and validation, we provide comprehensive support throughout the entire lifecycle of your bio-pharmaceutical facility.

We have experience in setting up below facilities –

• Fermentation-based APIs (Upstream & Downstream)
• Microbial and Mammalian based cell culture.
• Fill – Finish
• BSL 2/3/4 facilities
• Blood Plasma Fractionation
• Insulin
• Human/Veterinary Vaccines
• Foot & Mouth Disease Vaccines (FMD)
• Biosimilar mAb
• Gene Therapy