Our state-of-the-art facility is designed and built to meet highest FDA and EMA GMP requirements globally. Alvotech’s primary focus is on safety, compliance and flexibility. We strive to combine development with clinical and commercial demands for many products and to meet the needs of customers both today and for many years to come.
Our operations are fully integrated, with drug substance, drug products and quality control testing and release within the same location, to support a lean and efficient flow. We are using single use technology to minimize cleaning validation and product changes over time.
The treatment of millions of patients around the world will depend on the safe and reliable production of biopharmaceutical medicines. Commitment, skill and experience is vital to help ensure the quality, from the first cell line cloning step to each time a new batch is released. At Alvotech, robust quality control and a reliable supply of medicines to our partners are the cornerstone of our business.
Alvotech is developing and manufacturing its biosimilar products under the highest standards in the industry. Our facility is designed and built to meet US FDA and Europe EMA standards. Single use technology is used to eliminate risks of cross contamination in fermentation and ensure high quality products.