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Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects

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Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects I. Outline of Regulatory Requirements for a Start-up Veterinary Biological Product Company in Regards to Establishing Itself and Licensing of First Vaccine with APHIS. Licensure Overview: First off, for new applicants, the facility should contact the Center for Veterinary Biologics (CVB) early in the production development process, so that a licensing reviewer can be assigned to help walk them through the regulatory process. This will help in preventing hang ups and unnecessary mistakes within the process. Obtain necessary permits, request to receive organism, product formulation: Veterinary Services Memorandum No. 800.50, gives guidance on the requirements for obtaining a U.S. Veterinary Biologics Establishment License, per title 9, Code of Federal Regulations (9 CFR), section 102.3(a), and a U.S. Veterinary Biological Product License, per 9 CFR 102.3(b). This document also specifies the information and documents needed to complete licensing actions for APHIS. For an Establishment License, the applicant must submit the following: 1. Application for U.S. Veterinary Biologics Establishment License: by submitting APHIS form 2001. 2. Articles of incorporation for the applicant and any subsidiaries, if applicable: 9 CFR 102.3. 3. Water quality statement (9 CFR 108.11): Submit a statement from local water authorities to verify that the facility is in compliance with regulations for effluent waste. 4. Application for at least one U.S. Veterinary Biological Product License and any applicable supporting documents (listed in the rest of the licensure overview): by submitting APHIS Form 2003. 5. Qualifications of Veterinary Biologics Personnel for key employees (9 CFR 114.7(a)): by submitting APHIS Form 2007. 6. Facility blueprints, plot plans, and legends (9 CFR 108.2-108.5). Must submit two copies of each document. Refer to Veterinary Services Memorandum 800.78 for guidance on preparing facility documents. New Concept Discovery When developing a new concept discovery the following concerns are addressed: a. Is there epidemiology or economic importance? b. Determination: research must determine if there is any other information which exists already? c. Will the vaccine be safe and effective? 1 Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects Development Plan/ Development Process Agent Identification 1. Characterization 2. Confirmation Genome Characterization 1. PCR Methodologies 2. Sequence Comparison Challenge Systems 1. Challenge Virus Preparation Clinical, Virological, Serological, and Histological Characterization 1. Cell Line Adaptation/ Comparison a. Yield Optimization 2. Infectious Assay Systems a. Plaque Assay b. TCID50 3. Antibody Assay Systems a. Neutralization Assay b. IFA c. ELISA d. Any Other Testing 4. Reagents a. Neutralization Reagents b. Infectivity Standards c. Monoclonal Antibodies d. Control Antibodies 5. Antigen Assay (Potency/Dose Standardization) a. Antigen Capture ELISA b. Western Blot c. Any Other Testing Present to USDA 2 Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects USDA reviewer is responsible for assuring the submitted material meets the regulatory requirements. The USDA reviewer and Firm Representative (Liaison) are responsible for communicating frequently, in order to keep the process moving forward on the right track. CVB will review supporting data and provide official responses to each submission. Each submission will be sent back by hard-copy mail. Once CVB-PEL (Center for Veterinary Biologics: Policy, Evaluation, and Licensing) has reviewed the license application and supporting documents and the applicant has made satisfactory progress toward licensure of at least one product, the CVB-IC (Inspection and Compliance) will inspect the facility before granting licensure. CVB-IC is responsible for release of products and compliance for Outline of Production. Make any revisions that CVB recommends and submit for licensure. Submit Product License Application with supporting protocols and any reports, outline of production, and Summary Information Format (SIF) if product contains live organisms or Genetically Modified Organism (GMO): Application for product license, the following must be submitted: 1. Application for U.S Veterinary Biological Product License: by submitting APHIS Form 2003. 2. Outline of Production (9 CFR 114.8-114.9) and, if applicable, the facility should also send Special Outlines (9 CFR 114.9(b)), as well. Must submit two copies of each outline, each containing original signatures: Submit each outline with APHIS Form 2015 (an acceptable outline must be on file with CVB before licensure. See VS Memorandum 800.206 for additional guidance regarding preparation of Outlines of Production for vaccines, bacterins, antigens, and toxoids. (see section II of paper to see a more detailed account of the Outline of Production) The Outline of Production (9 CFR 114.8-114.9) consists of the following: a. Composition of the Product i. Microorganisms used ii. Source and date of accession of each microorganism iii. Strains iv. Proportions of each strain b. Cultures i. Methods of identifying each microorganism ii. Virulence and purity of cultures and the determination and maintenance thereof. Range of subcultures and passages to be used in production iii. Composition and reaction of media used for seed and production cultures 3 Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects 1. Master Cell Stocks 2. Eggs, tissue or primary cells 3. Composition of media iv. Character, size and shape of containers used for growing cultures v. Storage conditions vi. Methods of preparing suspensions for seeding or inoculation vii. Technique of inoculation viii. Conditions for incubation used for each microorganism or group of microorganisms ix. Character and amount of growth; observation as to contamination of growth x. Method of attenuation before use in production c. Harvest i. Handling and preparation of cultures and media before removal of microorganisms or tissues for production purposes ii. Minimum and maximum period of time elapsing from time of inoculation until harvest iii. Technique of harvesting microorganisms or tissues for production purposes iv. Specification for acceptable harvest material v. Handling of discarded material not used in production vi. Additional pertinent information d. Preparation of the Product i. Method of inactivation, attenuation, or detoxification ii. Composition of preservative, adjuvant, or stabilizer iii. Method and degree of concentration iv. Standardization of product v. Assembly of units to make a serial vi. Volume of fill vii. Method and technique of filling and sealing final containers viii. Desiccation, including moisture control ix. Amount of antigenic material per dose in final container e. Testing: i. Purity ii. Safety iii. Potency iv. Moisture v. All other testing f. Post Preparation Steps: i. Form and size of final containers ii. Collection, storage, and submission of representative samples 4 Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects iii. Expiration date iv. Use, dosage, and route of administration v. Site of manufacture 3. Master Seed and Cell Reports. For each microorganism (Master Seed) and cell stock (Master Cell) used in the production of biological products, a report that describes testing performed to evaluate the purity, identity, and safety of the seed and cell must be submitted. The source from which the seed or cell was obtained from and all known passage history must also be submitted. For guidance see VS Memorandum 800.109 and refer to the following for even further guidance if needed: 9 CFR 113.27 (c & d), 9 CFR 113.51-113.52, 9 CFR 113.55, 9 CFR 113.64, 9 CFR 113.100, 9 CFR 113.200, and 9 CFR 113.300. 4. Summary Information Formats (SIFs). Master Seeds to be used in the production of new live biological products and for all Master Seeds produced by recombinant DNA technology, the applicant must submit additional safety and identity data, which is provided in the SIF. A completed SIF is required before licensure. Although, the SIF is considered an “expandable document” which is continuously updated as applicable data are generated to support the license application. The applicant must submit two copies. VS Memorandum 800.205 can be used for additional guidance in preparation for the SIFs. 5. Protocols for studies of host animal immunogenicity/ efficacy, safety, back passage, shed/spread, immunological interference, and other applicable areas. The applicant must submit two copies of each protocol at least 60 days prior to the proposed initiation date of the study, if you want CVB to provide comments on the proposed protocols, which is highly recommended. For more guidance on study design the applicant may refer to the following: VS Memorandums 800.73 & 800.200 – 800.204. Laboratory Safety studies Product safety reports for the following must be submitted, also in duplicate forms: 1. Studies in laboratory animals. 2. Studies in host animals under biocontainment, including overdose studies. 3. Data to establish the safety of new, or significantly different, antigen-adjuvant formulation or additive. This also includes the following: a. The establishment of a slaughter withholding period for products used in domestic animals, the edible portion of which may be used for food purposes. Refer to 9 CFR 112.2(8) and guidance for establishing slaughter withholding periods is available in VS Memorandum 800.51
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