AM Life Science (AMLS) was recently engaged to help a prominent biopharmaceutical contract development and manufacturing company gain FDA approval of a multi-facility process as they prepare for the manufacture of a new, promising viral vector gene therapy.
Our experienced team will assist with the commissioning, validation and operational readiness of the utilities, equipment and process for these new, state of the art manufacturing suites as well as support facilities, totaling greater than 100,000 square feet of allocated space. Being involved on the front end of a new facility buildout allows AMLS to integrate downstream quality aspects early in the process. This is at the core of the AMLS approach, by focusing on First-Time-Right enabling project success in delivering objectives of cost, quality and schedule.
“In addition to a quality minded approach, we also give every project 100% because we truly value the hard work our clients and their organizations do to support the patients that count on them. We are proud to be able to contribute to that effort in any way we can,” says Rod Azadan, Head of AM Life Science.
For an owner-centric CQV partner, Contact AMLS Today!
