a “Biologics License Application (BLA)”. BLA should comply requirement as specified under 21 CFR 600.Since this is quality assignment, we will be submitting We will be submitted following section of E- Common Technical Document (eCTD)1. Module 2.3 Quality Overall SummaryThis includes general introduction to the Recombinant Erythropoietin, including its pharmacologic class, mode of action, and proposed clinical use.
The introduction should include proprietary name, nonproprietary name or common name of the drug substance, company name, dosage forms, strengths, route of administration, and proposed indications. This will not exceed one page. Since Recombinant Erythropoietin is biotechnological product, a description of the desired product and product-related substances and a summary of it general properties, characteristic features, and characterization data (for example, primary and higher order structure and biological activity).
The QOS should summarize the data on potential and actual impurities arising from the synthesis, manufacture, and/or degradation and should summarize the basis for setting the acceptance criteria for individual and total impurities. The QOS should also summarize the impurity levels in batches of the drug substance used in the nonclinical studies, in the clinical trials, and in typical batches manufactured by the proposed commercial process. The QOS should state how the proposed impurity limits are qualified. 2. Module 3. Quality Information related Recombinant Erythropoietin on Quality should be presented in the structured format described in the guidance M4Q.
MODULE 3: QUALITY SECTION OF THE CTD: This includes detailed description of – The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing should be provided. physicochemical and other relevant properties of the Recombinant Erythropoietin- Manufacturing process represents the applicant’s commitment for the manufacture of the drug substance. Information should be provided to adequately describe the manufacturing process and process controls- SPECIAL CONSIDERATIONS: Since this is Biotech product, information should be provided on the manufacturing process, which typically starts with vials of the cell bank and includes cell culture, harvests, purification and modification reactions, filling, storage, and shipping conditions.- An explanation of the batch numbering system, including information regarding any pooling of harvests or intermediates, and batch size or scale should be provided- Relevant information for each stage, such as population doubling levels, cell concentration, volumes, pH, cultivation times, holding times, and temperature should be included. Critical steps and critical intermediates for which specifications are established (as mentioned in 3.2.S.2.4) should be identified.- Filling, storage and transportation (shipping) details – SPECIAL CONSIDERATIONS FOR BIOTECH PRODUCTS::Control of Source and Starting Materials of Biological Origin Summaries of viral safety information for biologically sourced materials should be provided- Source, history, and generation of the cell substrate- SPECIAL CONSIDERATIONS FOR BIOTECH PRODUCTS: Cell banking system, characterization, and testing- Sufficient information should be provided on validation and evaluation studies to demonstrate that the manufacturing process (including reprocessing steps) is suitable for its intended purpose and to substantiate selection of critical process controls (operational parameters and in-process tests) and their limits for critical manufacturing steps- Cell culture and harvest – Purification and modification reactions- Filling, storage and transportation (shipping)- Control of Source and Starting Materials – Source, history, and generation of the cell substrate- Sufficient information on validation and evaluation studies – Container Closure System- Stability data and Conclusion
