Amatsigroup Manufactures Injectable Clinical Batch Under Single-Use Isolator

Amatsigroup, a contract development and manufacturing Organization (CDMO) located in France, unveiled what it says is the world’s first-in-class manufacturing of a clinical injection batch under single-use isolator, a major global breakthrough currently to be used in the treatment of acute ischemic stroke.

In January 2017, Amatsigroup acquired Disposable Lab, which specializes in the production of small batches of pharmaceutical drug products in Martillac, France. The design of the production area is based on the use of the assembly of disposable materials—single use isolator and material in contact with the product—in fresh air modules. This very specific design is a major asset for the production of small batches of bio/pharmaceutical drug products and medical devices (<2,500 units per batch), for small filling volumes (e.g. 15μL), for volatile products, viscous or sticking products and in particular those where the cleaning procedure is problematic. These installations are compatible with the distribution of powders in aseptic condition, with a +/- 0.1 mg accuracy for continuous filling in vials. The isolator and filling line offer great flexibility and allow distribution, in aseptic conditions, of different packaging, including vials, IV pouches, cartridges as well as capsules and any other primary packaging.

This sterile manufacturing site in Martillac has performed its first Media Fill Trial (MFT) for Acticor Biotech on the current line as of May 2017, and produced the first clinical injectable batch for a phase I trial in Europe. According to the company, this single-use technology for the manufacturing of clinical injectable batch is a world breakthrough.

This specific technology is also of interest in the handling and production of small series of hazardous and/or living microorganisms. The site is being accredited for the production of clinical batches requiring to be handled under BSL2 (e.g. bulk of living aerobic bacteria). In addition, Amatsigroup will invest during the year, with the objective to produce live organisms requiring manipulation in a BSL3 environment.

For any other product that does not require this technology or for larger batch productions, the Amatsigroup site in Idron, France, offers batch dispatch technology under fixed isolators. The site of Idron manufactures liquid or lyophilized forms, up to 10,000 - 25,000 units, depending on the packaging format.

"This success is the combination of a fantastic team in Martillac, a great partnership with our supplier of disposable isolators, Solo Containment in UK, and the confidence of Acticor Biotech in our technology," said Jean-Pascal Zambaux, site director of Martillac - Amatsigroup.

Gilles Avenard, chief executive officer, Acticor Biotech, said, "We have been very happy to experience the flexible fill and finish facility of Amatsigroup, Martillac site, for our first GMP batch. The technology is very promising for small batches as it could be translated very easily according to the ‘single use lab paradigm’ without any impact on the validation process."