AVS Life Sciences will help your team's quality, regulatory, and CQV departments develop and manufacture Food & Nutraceutical to ensure the products are consumable, safe and effective for your enjoyment, benefit and care.
Services
Cell & Gene
Therapy
This manufacturer was using a multi-product Biosafety Level 1 GMP facility throughout their product and process development. The facility was used to manufacture drugs intended for phase 1 and 2 clinical trials.
While this Level 1 facility provided the client’s desired functionality at the time, they wanted to manufacture lentivirus vector material. To fulfill this goal, our client needed to upgrade their manufacturing facilities to be compliant with Biosafety Level 2 GMP standards, a requirement for this material.
This Cell and Gene Therapy project required AVS’s support to guide the client’s engineering, validation, and technician groups to modify the Level 1 facility, and install, commission, and qualify the new equipment within 9 months.
DIVIDED INTO 2 PARTS:
Modify the existing facility
Install, commission, qualify new equipment, and prepare preventive maintenance
AVS collaborated with the client to enhance their manufacturing facility by conducting a gap analysis that revealed differences between the current setup and the required Level 2 facility. A new layout was created and approved, followed by equipment procurement, where AVS managed vendor communications and documentation. AVS guided the installation of complex equipment, conducting commissioning protocols to validate functionality across over 80 new pieces of equipment. The process included qualifications (IQ/OQ/PQ) and computer system validation to meet GMP standards. After installation, AVS developed preventive maintenance plans and handed off the documentation to the client. Throughout the 9-month project, AVS maintained clear communication, managed task delegation, and held monthly budget review meetings with client leadership to ensure on-time, on-budget delivery.
AVS assisted our client in upgrading their manufacturing space from a Biosafety Level 1 GMP facility to a Level 2 GMP facility. We were able to complete the entire project on schedule and within budget. Moreover, our documentation efforts to demonstrate full traceability was deemed appropriate by our client’s quality assurance team. We were able to support our client throughout this entire transition process, from gap analysis to final equipment installation. Because of our efforts, this pharmaceutical manufacturer was able to manufacture medication with the lentivirus vector material. This collaboration allowed our client to focus on what they do best – develop medicines to help improve their target patient’s quality of life.