Manufacturing

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.

Biosimilars in production
7

Manufacturing and in-house R&D.

Key facts

  • One of the newest facilities in the industry for R&D, API manufacturing and filling of biopharmaceuticals
  • 13,278 square meters facility and laboratories, including 2500 square meters of office space
  • A blend of 1000L and 2000L disposable fermentation technology for mammalian cells drug substance DP production, for a total capacity of 16,000L
  • Proven high yield fermentation and downstream process
  • Aseptic filling and finishing lines for vials and prefilled syringes
  • cGMP manufacturing capacity for clinical and commercial scale facility
    FDA/EMA GMP standards
  • High throughput R&D capabilities and development suite

QUALITY MINDSET


Quality control
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.

Meeting standards
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.

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