APPENDIX D - BIOLOGICAL ASSESSMENT QUESTIONNAIRE & BIOPROCESS SAFETY CHECKLIST

Transcription

1 Guidelines for Process Safety in Bioprocess Manufacturing Facilities by Center for Chemical Process Safety Copyright 2011 American Institute of Chemical Engineers, Inc. APPENDIX D - BIOLOGICAL ASSESSMENT QUESTIONNAIRE & BIOPROCESS SAFETY CHECKLIST One company uses forms similar to these one to collect data for performing a biological characterization assessment. Consider your facility's needs and adapt them for your specific bioprocesses. The following questions may provide guidance in assessing and performing a risk assessment for a given project/process: Section 1. A. - Microorganisms involved: Does the process involve the use of any microorganisms? If NO, proceed to Section 2. If YES, list the name of the organism and any other relevant information as to its source/history below, (for example, the ATCC number): What is the Risk Group of the organism? A. Is the organism infectious? If NO, proceed to Section 1. B. 179

2 180 GUIDELINES FOR PROCESS SAFETY IN BIOPROCESSING What is the standard mode of transmission? What is the infectious dose, if known? Is there vaccination or prophylaxis available? If YES, what is it? Has the organism been inactivated by a tested procedure during processing? If YES, provide details on the process and the inactivation data below. Section 1. B. - RDNA GLSP Aspects: Has the organism been modified through recombinant DNA technology? If NO, proceed to Section 2. Does the organism meet the criteria for GLSP? What Biosafety Level was assigned to the construct by the institution's RDNA biosafety oversight committee? Section 2. Cell Lines

3 APPENDIX D 181 What types of cells are being used? List cell source species, tissue or cell? Provide ATCC number or other available information if purchased: Is it a primary cell line or continuous cell line? Has the cell line been tested for adventitious agents? Does it have any viral genetic material integrated into its genome? Section 3. Use of animal materials in the process Does your project involve animal Sourced materials in the process? If YES, list the type of material, providing the source animal and country of origin: Section 4. Process related issues What is the maximum volume of material that you will be processing in a single vessel? Describe the general process for culture and purification. Indicate whether the entire process will be contained, (attach pages if necessary) Section 5. Recombinant DNA Does your project involve any recombinant DNA constructs?

4 182 GUIDELINES FOR PROCESS SAFETY IN BIOPROCESSING Do any of the recombinant molecules contain 1/2 or more of the viral genome? If YES, approximately how much? Does the construct contain genetic material from an infectious agent? If Yes, what is the agent and what portion of the genome is included? Does the project involve the use of viral vector systems? If Yes, specify the virus and any helper viruses that may be present below: Does the project involve the transfer of drug resistance to organisms that does not acquire it normally? Does the construct code for any molecules that are toxic? Does the construct code for any materials that are biologically active? Will the construct be used for large scale production purposes? (Note that the volume is generally 10 liters for low-risk work. Work with infectious materials requires review of all cultivation of infectious materials.):

5 APPENDIX D 183 If Yes, please answer the following to determine if the process qualifies as GLSP: Is the organism viable? Is the organism non-pathogenic? Is the organism non-toxigenic? oyes ono Does it involve recombinant strains derived from host organisms that have an extended history of safe large scale use? Does the organism have built-in environmental limitations that permit optimum growth in the large scale setting but limited survival without adverse consequences in the environment? a YES Is the vector insert well characterized? a YES Is the vector insert well characterized? Is the vector insert free from harmful sequences? Is the vector insert limited in size as much as possible to the DNA required to perform the intended function? a YES ono

6 184 GUIDELINES FOR PROCESS SAFETY IN BIOPROCESSING Is the vector insert poorly mobilizable? Does the vector insert increase the stability of the construct in the environment? Does the vector insert transfer any resistance markers to microorganisms not known to acquire them naturally if such acquisition could compromise the use of a drug to control disease agents in human or veterinary medicine or agriculture? Section 6. Biological Toxins Does your project involve biological toxins? List toxin(s) and volumes that will be on site below: Is this a Select Agent Toxin? Additional Comments:

7 APPENDIX D 185 Bioprocess Safety Checklist - Detailed (Project Title and Number) (Product Process or Method Name) PROPERTIES (Y/N) GAP COMPLETION COMMENTSI DATE FOR CRITICAL OUTSTANDING (Y/N) Organism/Cell Line Characteristics List name of organism/cell line. List designated Biosafety Level of wild type. Describe deactivation procedures for organism/cell line. Pathogenic to: (circle as applicable) Humans? Animals? Plants? Mode of Transmission: (circle as applicable) Inhalation? Ingestion? Injection? Mucus Membrane? Is the organism/cell line genetically modified to be a Living Modified Organism (LMO)? List designated Biosafety Level of LMO. List designated Biosafety level for large scale process of LMO. Can LMO cause adverse effects to humans, animals, plants or the environment as a result of establishment or dissemination? Does LMO have potential to [transfer inserted genetic material

8 186 GUIDELINES FOR PROCESS SAFETY IN BIOPROCESSING Bioprocess Safety Checklist - Detailed (Project Title and Number) (Product, Process or Method Name) PROPERTIES to other organism? (Y/N) GAP COMPLETION COMMENTSI DATE FOR CRITICAL OUTSTANDING (Y/N)! Does the LMO have built in biological barriers, which confer limited survivability and replicability, without adverse consequences in the environment? General Physical Characteristics of the Product List the product. Specify physical state of product (for example, protein solution, lyophilized powder, whole broth) Specify water solubility. Specify ph. Toxicological Properties of Product Acute toxicity Repeat dose toxicity (target organs) Skin Irritation Eye Irritation Skin/respiratory sensitization Reproductive effects Genetic toxicity

9 APPENDIX D 187 Bioprocess Safety Checklist - Detailed (Project Title and Number) (Product, Process or Method Name) PROPERTIES (Y/N) GAP COMPLETION COMMENTS DATE FOR CRITICAL OUTSTANDING (Y/N) Carcinogenicity Pharmacological effects Occupational/Industrial Hygiene (IH) Occupational Exposure Limit Occupational Exposure Band Industrial hygiene analytical method Industrial hygiene sampling method Industrial hygiene monitoring data Flammability of Liquids in Process Flash Point Auto-Ignition Temperature LOC (Liquids) Flammability of Solids In Process Train Fire Minimum Ignition Temperature - cioud Minimum Ignition Temperature - Layer ENVIRONMENT

10 188 GUIDELINES FOR PROCESS SAFETY IN BIOPROCESSING Bioprocess Safety Checklist - Detailed (Project Title and Number) (Product, Process or Method Name) PROPERTIES I (Y/N) I GAP CRITICAL (Y/N) COMPLETION COMMENTS DATE FOR OUTSTANDING Water solubility Dissociation Constants (pka) Vapor Pressure Volatility Distribution Coefficient (Log Dow) Activated Sludge Respiration Inhibition Test (ASRIT) Sludge/soil adsorption/desorption Microbial toxicity Acute toxicity to Daphnia (EC50, 48 hrs) Acute toxicity to fish (LC50, 96 hrs) Degradation Mechanisms- 1. Photodegradation 2. Biodegradation 3. Hydrolysis Occupational Health Program Immunization available Anti-serum/Anti-toxin Special requirements/recommendations (for example pregnancy, immunosuppression)