GMP Manufacturing

GMP production of clinical trial material (CTM) is usually the last developmental milestone before introducing your drug into clinical trials. Assuming that your drug development process was continuous and without significant challenges, this milestone is usually achieved 9-12 months after formulation development begins.

Clinical Trial production is very different from mass production. At the commercial stage, the drug is already well defined, and the production process is carried out by line operators dedicated to specific products. However, in the early stages of development, the product is still evolving, hence the production process is subjected to changes. As challenges might arise during manufacturing, it is necessary to provide real-time solutions that will meet the regulatory requirements. Therefore, CTM production is usually performed by development scientists with vast knowledge and experience in different production processes.

 

          Tip from our scientists

The primary package (i.e., tubes, bottles, vials, etc.) affects not only the filling and closure procedures for your products but also has a great effect on product stability. It is recommended to choose the primary packaging components during formulation development in order to gain as much information as possible on packaging compatibility with the product. Short term stability study at this stage may provide some information about leaking, change of color, and other characteristics that might be affected by the package.

 

Services for you

  • Drug and medical device manufacturing for Phase I-III studies in a GMP certified facility, according to FDA and EMEA requirements.

  • Aseptic manufacturing of sterile products in ISO 5 (class 100) cleanrooms (suitable for parenteral and ophthalmic solutions, topical creams for open wounds treatment, etc.)

 

 

  • Analytical and stability testing for the finished product.

 

  • Full QA/QC support and QP services.

  • Clinical labeling and packaging.

  • Planning and executing scale-up processes for formulations developed by the client or by us (including Technology transfer to and from Nextar).

 

  • Development and manufacturing of special drug delivery systems such as liposomes.

  • Preparation of Chemistry, Manufacturing, and Controls (CMC) supporting documentation for submission to regulatory agencies.

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