LAMPIRE Hybridoma Project Initiation Form

Transcription

1 1. General Information Company / Institution: Investigator Name: Contact Name: Phone: Fax: 2. Billing / Shipping Information Accounts Payable contact: Company: Dept./Bldg./Room#: Address: Project Name / Number: PO# Credit Card# (Name on Card & Exp Date): Ship to contact: Company: Dept./Bldg./Room#: Address: City, State, Zip City, State, Zip Phone: Carrier (FedEx, UPS, etc.) Fax: Your carrier #: 3. Scope of Project What is the proposed end use of the antibody? (ie. ELISA, Western Blot, IHC, etc.) If the end use is a cell based assay or has an endotoxin requirement, please state the endotoxin limits. Are there any special project requirements? (ie. Cross Reactivity, Ab Performance, etc.) Eu/mg 4. Immunogen Information Peptide Recombinant Cysteine Carboxyl Amino 5. Primary Screening Antigen Information Peptide 5a. Secondary Screening Antigen Information Recombinant 4 C -20 C -70 C Yes No If additional immunogens or screening antigens are required please check here: Please see page 5 or 6 (Addendum A) for additional Immunogen & screening antigen information sections. 6. Additional Antigen Information Peptide Recombinant 4 C -20 C -70 C Page 1 of 6 Yes No 4 C -20 C -70 C Yes No

2 7. Additional Antigen Information Has the antigen sequence been checked to determine whether it is conserved in mice? Yes No NOTE: If the antigen is conserved in mice, an animal of a different species may be recommended for generation of the monoclonal antibody. If this information is not known, LAMPIRE will examine the antigen structure and determine whether or not the antigen is conserved and among which species it is conserved. Has the antigen been used previously to generate an immune response in an animal? Yes If so, what species was used to generate the antibody? Antigen Structure (Peptide Sequence/Hapten with Spacer): No 8. Immunization Protocol Strain of Rodent for Immunization: (LAMPIRE does not use SCID or Nude mice for hybridoma development projects.) Balb/C Female Mice (9-12 weeks) Sprague Dawley Rats (200g) Other Number of Rodents to Immunize: (Projects typically begin with 5 or 10 mice or 3 rats) Mice: 5 10 Other Rats: 3 Other Recommended Injection Concentration and Volume: Please choose from one of the Immunization Protocols below. If a modified protocol is to be used, please describe. Standard Immunization Protocol: Modified Immunization Protocol (describe below): Day 0 - Pre-Bleed and 1st Injection (Complete Freunds) Day nd Injection (Incomplete Freunds) 1 Day Test Bleed Day ELISA Screen Additional injections and bleeds can be performed as needed. Additional injections will be given 18 days after the last bleed and will be followed by a test bleed 10 days after the injection unless otherwise directed. Screening of Bleeds is performed by ELISA. If you would like ELISA performed, please describe the screening strategy: Do you wish to screen the test bleeds by the Final Assay Format? If Yes, test bleeds will be shipped to client (Mice ~10µL & Rats ~50µL). 2 Yes No NOTE: Mice will be maintained at LAMPIRE for a period of 3 months. After that time and with no continuing activity other than husbandry, a charge of $1/box of mice per day will be charged for husbandry of the animals. 1 LAMPIRE performs all screening by ELISA. The assay verifies whether or not the animal has developed an immune response against the injected material. 2 If possible, LAMPIRE recommends that Test Bleeds (and/or supernatant) be evaluated in the Final Assay Format. If the Test Bleeds do not perform in the Final Assay Format, the antigen may need to be modified or additional injections may need to be performed. Page 2 of 6

3 9. Specifications for Fusion and Screening How will the fusion candidate be selected: Lampire data Client data Both Rodents are boosted IP 3 consecutive days prior to fusion with the same injection concentration recommended in Section 8. Other immunization strategies are available upon request. If the following selections are dependent upon fusion data, LAMPIRE will contact you to discuss after release of the data. Number of Growth Wells to select for subcloning: 3 Other Screening of Growth Wells is performed by ELISA. Should samples (1mL supernatant) be shipped to you for another screening format? Yes No Do you want to screen the Growth Wells by the Final Assay Format? If yes, how many at a time? (LAMPIRE suggests this be done after 1X cloning or within 1 week of shipment.) Yes No Criteria for selection of Growth Wells for subcloning: After subcloning, 3mL of supernatant will be provided. LAMPIRE will be in contact with you to discuss future needs such as larger scale production, cell banking and purification. 10. Octet Antibody Characterization The Octet instrument allows real-time analysis of biomolecular interactions in a microplate format. Tests are predominantly performed using a biotinylated sample, which may be provided by the client or by Lampire. Antibody Quantification Antibody Kinetics Antibody Isotyping Epitope Binning Antibody Pair Testing Antibody Pairs Screen Small Molecule Kinetics Determine the amount of IgG present in your sample. Study quantitative dissociation data and relative on-rates for one antibody-antigen pair or multiples. Identify the isotype (IgG1, IgG2a, IgG2b, etc.) of your antibody. A test is screening 1 antibody vs. 1 other antibody with 1 antigen. To screen 6 antibodies and bin them vs. 1 antigen would be 6 tests. Assumes a pre-established known antibody is available, which is tested against candidate antibodies in a sandwich format. A test is 1 known antibody vs. 1 unknown antibody. Will be performed on in-house screened candidate antibodies. Requires binning to be performed first to establish potential pairs, followed by biotinylation, then sandwich assay screening of potential pairs. Evaluate the binding of small molecules to a test protein. Note: This involves a minimum $300 plate charge. Yes No Yes No Yes No Yes No Yes No Yes No Yes No 11. Immunochemistry Services ELISA: Yes No Purification: Yes No A G Affinity Conjugation: Yes No KLH BSA Peptide Synthesis: Yes No Sequence: Page 3 of 6

4 12. IACUC (Institutional Animal Care and Use Committee ) Requirements Lampire Biological Laboratories, Inc., in compliance with federal regulations, presents each animal-use project to IACUC (Institutional Animal Care and Use Committee) for approval prior to project initiation. Criteria for acceptance of a project are established in 9CFR, Chapter 1: Animal and Plant Health Inspection Service, USDA, Subchapter A Animal Welfare. To expedite initiation of your project, please complete the following questions and assurances as thoroughly as possible. If your company or institution is a USDA-registered facility with an IACUC of its own, Lampire may accept an approved Animal- Use Proposal from that committee. If any questions arise during our IACUC review of your project, a committee member will contact you for clarification. Please briefly state your rationale for the appropriateness of the species of animals used for this activity: (i.e., "Goats are appropriate host animals due to the volume of serum required in our project." or "Sheep are appropriate host animals due to their immunologic response to the antigen refinements. " or "Donkeys are appropriate host animals for this project as the characteristics of their antisera are consistent with established requirements for further manufacturing." Your signature below indicates that this project does not unnecessarily duplicate previous experiments or projects, the number of animals has been minimized and alternatives to animal use have been considered. Client Signature Print Name Date 13. Pricing Information Quotation No.: Standard Catalog Price 14. Labeling and Shipping Instructions Please label your antigen(s) accordingly as depicted below. Improperly labeled antigen(s) may delay the start of your project. IMMUNOGEN Project: Client Antigen: Conjugate: Lot #: Conc: mg/ml Vol: ml Storage: C SCREENING ANTIGEN Project: Client Antigen: Conjugate: Lot #: Conc: mg/ml Vol: ml Storage: C Unless otherwise instructed by LAMPIRE project management, ship antigen and a copy of this completed form to: LAMPIRE Biological Laboratories, Inc. Attn: Antigen Receiving Dept Applebutter Rd. Pipersville, PA Print a copy of the completed form for your records. Submit completed form via or fax completed form to If you need assistance in completing any portion of this form, please call Project Approval (LAMPIRE use only) Lampire Project Management Approval Date Lampire Technical Support Approval Date Page 4 of 6

5 ADDENDUM A - Additional Immunogen 4a. Additional Immunogen Information Peptide Recombinant Cysteine Carboxyl Amino 4 C -20 C -70 C Yes No 4b. Additional Immunogen Information Peptide Recombinant Cysteine Carboxyl Amino 4 C -20 C -70 C Yes No 4c. Additional Immunogen Information Peptide Recombinant Cysteine Carboxyl Amino 4 C -20 C -70 C Yes No 4d. Additional Immunogen Information Peptide Recombinant Cysteine Carboxyl Amino 4 C -20 C -70 C Yes No Page 5 of 6

6 ADDENDUM B - Additional Screening Antigen 5b. Additional Screening Antigen Information Peptide Recombinant 4 C -20 C -70 C Yes No 5c. Additional Screening Antigen Information Peptide Recombinant 4 C -20 C -70 C Yes No 5d. Additional Screening Antigen Information Peptide Recombinant 4 C -20 C -70 C Yes No 5e. Additional Screening Antigen Information Peptide Recombinant 4 C -20 C -70 C Yes No 5f. Additional Screening Antigen Information Peptide Recombinant 4 C -20 C -70 C Yes No Page 6 of 6