Good operations practice supervisor profiles in cell-centric manufacturing

Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

Current good manufacturing practice for positron emission tomography drugs.

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulatio...

Good manufacturing practice for immunological veterinary medicinal products.

Good manufacturing practice (GMP) is applied to the manufacture of immunological veterinary medicinal products (IVMPs) in a number of regions around the world. Within the European Union (EU) there are well-established requirements for GMP in the manufacture of IVMPs. Maintaining GMP when producing IVMPs is important because there are particular risks associated with their manufacture. These ris...

Good manufacturing practice-compliant expansion of marrow-derived stem and progenitor cells for cell therapy.

Ex vivo expansion is being used to increase the number of stem and progenitor cells for autologous cell therapy. Initiation of pivotal clinical trials testing the efficacy of these cells for tissue repair has been hampered by the challenge of assuring safe and high-quality cell production. A strategy is described here for clinical-scale expansion of bone marrow (BM)-derived stem cells within a ...

Good manufacturing practice and clinical-grade human embryonic stem cell lines.

Human embryonic stem cell (hESC) lines, after directed differentiation, hold the greatest potential for cell transplantation treatment in many severe diseases. Good manufacturing practice (GMP) quality, defined by both the European Medicines Agency and the Food and Drug Administration, is a requirement for clinical-grade cells, offering optimal defined quality and safety in cell transplantation...