We firmly believe that the quality of our products is central to the fulfilment of your needs since reliability and uniformity are the essence of successful cellular therapies. Therefore, we put efforts and commitment into our quality management system. From process development to shipping of the final product, our quality management oversees the entire product life cycle.
Feldan’s quality management system is oriented towards:
• Ensuring safety of our products that are incorporated in clinical cellular therapies
• Manufacturing products with robust and controlled processes
• Facilitating preparation and approbation of regulatory dossiers
• Ensuring efficient manufacturing
• Pursuing continuous improvement
CHOOSING THE RIGHT PRODUCT LINE
Feldan offers three product lines with specific quality control and quality assurance characteristics that are adapted to the requirements of the different development phases of your cell therapy.
Feldan provides high-quality ancillary materials and submits all of its products to a rigorous series of tests to ensure constant quality, efficacy, safety, identity and purity.
Because protein homology is often high between cytokines of the same families, detection methods used to prove identity must be highly specific. Feldan’s scientists use western blotting, a method that leads to the unambiguous physical identification of the recombinant protein.
Cytokines are highly specialized proteins involved in a vast array of distinct cell processes; however, one biological activity that is common to all commercially available cytokines is the effective influence on cell proliferation. Biological activity assays allows the direct quantification of the intrinsic proliferative or inhibitive capacity of the cytokine by measuring the cell amplification induced or repressed by its addition. Cell lines are chosen based on the specificity of each cytokine to promote or inhibit growth of precise cell types.
The verification of purity allows the detection and relative quantification of additional proteins and/or oligomerization forms. To certify purity we detect all the proteins in a cytokine sample using gel electrophoresis (SDS-PAGE), followed by a non-specific revelation. Following the use of this method, contamination percentage is the sum of the calculated intensities of all contaminants (i.e. signals that can be detected and quantified outside of the main cytokine band) divided by the overall staining intensity of the gel. In this context, purity is defined by the difference of 100% minus the contamination percentage. Oligomerization forms are identified by western blotting using specific antibodies directed against the purified cytokine. Overall, this control limits the possibility of introducing unwanted proteins or oligomerization states in the cell therapy platform, thus alleviating the risk of adverse reactions caused by these elements.
Endotoxins are highly immune-reactive lipopolysaccharides present on the outer membrane of gram-negative bacteria. These elements are known activators of several cellular pathways in human, lead to infectious complications and are one of the causal elements of sepsis and septic shock. The cytokine you will receive has been screened by the use of the LAL test (“Limulus Amebocyte Lysate”) derived from the aqueous extracts of circulating amebocytes of horseshoe crab. The LAL test allows photometric detection of the level of clotting of the lysate induced by the presence of endotoxins. Results derived from the LAL test are compared with a standard curve made with known concentrations of endotoxin standards, in order to extrapolate precise content.
The main objective of the bioburden is to evaluate the microbiological quality of the recombinant cytokine batch. Bioburden assays, which follow the directives of the USP <61> guidelines, test the absence of bacterial growth in ancillary material sample on solid media. Initial steps are conducted to evaluate that the cytokine itself does not inhibit growth of objectionable microorganisms. Bioburden is conducted in an independent lab certified GMP-Analytic.
All raw materials that enter in the composition of our products are chosen for their quality and reliability. Moreover, product development has been specifically designed to exclude raw materials of animal origin.
Recombinant proteins of bacterial source:
All our products expressed in bacteria are produced without animal-derived raw material. For our raw materials and our process materials, we are looking for certification from our suppliers that the materials are of “Non-Animal Origin” or Animal-Derived Component Free “ADCF”. However, some components used during the process may be from animal origin (ex: Heparin Sepharose in downstream process). In this case, only safe animal-derived material is accepted. If possible, it is pharmaceutical grade and we obtain from our supplier certification of the animal species, tissue of origin and country of origin. Feldan recombinant proteins can be classified in two categories based on absence of animal-derived component in raw material and process material.
Category 1: Raw materials and process materials are certified Animal-Derived Component Free. In that case, we obtain certification from all our raw material and process material suppliers that the materials are of “Non-Animal Origin” or “ADCF”.
Category 2: Raw materials are “ADCF” but some process materials are animal-derived. For these process materials, only safe products are accepted. If possible, it is pharmaceutical grade and with these materials we obtain from our supplier certification of the animal species, tissue of origin and country of origin.
Recombinant proteins of mammalian source:
Our products expressed in mammalian cells contain, other than the cell themselves, raw materials and process materials that are animal-derived component free, if possible. For these raw materials, we have certification from our suppliers that the materials are of “Non-Animal Origin” or “ADCF”. However, when it is not possible, raw materials or process materials of animal origin are used but only safe animal-derived material is accepted. If possible, it is pharmaceutical grade and we obtain from our supplier certification of the animal species, tissue of origin and country of origin.
Category 3: Raw materials and process materials, other than the cells, are certified animal-derived component free. In that case, we obtain certification from all our raw material and process material suppliers that the materials are of “Non-Animal Origin” or “ADCF”.
Category 4: Raw materials or process material are animal derived. For these materials, only safe products are accepted. If possible, it is pharmaceutical grade and with these materials we obtain from our supplier certification of the animal species, tissue of origin and country of origin.