Biological material for the production of BMСP

  Many articles were devoted to biological products, but what is the raw material for the production of BMCP?

Certainly, it is some kind of biological material, but what? According to the Order 569n under Biological Material (BM) is implied:

  1. Biological fluids
  2. Tissues
  3. Cells
  4. Secrets and human metabolic by-products
  5. Physiological and pathological excretas
  6. Smears
  7. Scrapes
  8. Swabs
  9. Biopsy material

For example, cells called fibroblasts are used for the preparation of autologous biomedical cell product for the esthetic medicine (Details by link).

The BM is received in the organizations having the license for medical activity, on the basis of the contract between the medical organization and the manufacturer of biomedical cell products at the expense of the manufacturer.

Obtaining a BM for the production of BMCP for lifelong donation is allowed in the presence of informed voluntary consent expressed in written form. It is included to the medical documentation of the donor.

It also possible to obtain BM posthumously.

After receiving BM, the medical organization checks BM and issues the permission for   use of the BM for BMСP production. Then the permission together with the results of BM checking are given to the manufacturer of BMCP.

The BM, intended for the production of BMKP, has the following requirements:

  1. Availability of information about the viral contamination of the BM or donor (for autologous and combined BMCP)
  2. Absence of BM and/or donor contamination (for Allogenic BMCP)
  3. Absence of mycoplasma contamination cells received from the banks of cells and tissues
  4. Absence of contraindications to the BM donation established by the technological specification according to the data provided by the medical institution

During the input control at the production the analysis of all accompanying documentation is carried out, including:

  1. Sampling protocols
  2. Donor information
  3. Results of donor and donor BM surveys
  4. Transport documentation
  5. Transport conditions

Finally, BM moves to production stage, where in the future it becomes BMCP.