Star%ng a Custom An%body Project

Transcription

1 Star%ng a Custom An%body Project

2 The Process Consulta)on Offer & Quote Shipping/Invoice Informa)on Start of Project Shipping/Receiving Product 2

3 Consulta%on Phase I 3

4 Consulta%on To assure sa)sfac)on that the an)body developed will work the way you want we need to know the following (Op)onal) Do we have/need an NDA? Do you have the an)gen? Yes please fill out our an)gen submission form with the following informa)on for us to verify We may have addi)onal recommenda)ons to improve immunogenicity No? We can make protein and pep)de an)gens for you What is the end applica)on? Different An)gen may have different implica)ons for end applica)on We may recommend species, immunogen and method(s) for screening to validate func)on throughout development 4

5 What informa%on is needed for an%gen submission form? An)gen Name An)gen Type Pep)de Na)ve Protein Bacteria Lysate Recombinant Protein + Tag Other (DNA, Protein Fragment etc) Animal Species Quan)ty (mg) Size Purity Already conjugated to a carrier protein? Which? Storage condi)ons Form Solu)on Concentra)on(mg/ml) Buffer ph Incompa)bili)es lyophilized gel strip Safety Toxic? Radioac)ve? Derived from humans? Screening An)gen Others (Adjuvant type? Etc) 5

6 What informa%on is needed to design an%gens? Pep)des Accession number Purity Method of conjuga)on Protein Accession number Expression system Tag 6

7 QUOTE & OFFER Phase II 7

8 Quote AYer consulta)on we will generate an es)mated quote for the project and it to you to verify the services that will be provided We will also provide es)mated schedule Actual schedule may vary greatly as we may need to boost the animal for many more weeks than planned to achieve good immune-response Certain larger dollar projects may result in a mutually agreed Statement of Work We will also discuss different payment methods available at this )me. 8

9 Payment Methods We have flexible payment plans and accept the following methods of payment PO Check Cash Credit Card Typically payment is due within 30 days of invoice unless otherwise agreed upon 9

10 Shipping & Invoice Phase III 10

11 Shipping & Invoice Once the quote and payment method have been verified, an)gens can now be shipped and upon the receiving the an)gen a confirma)on instruc)ons on how to ship your an)gen and how we will ship your an)bodies will be discussed at this )me An invoice will be sent ayer the first shipment is made 11

12 Shipping Instruc%ons Fedex, UPS, USPS, and DHL are approved shipping carriers for customers sending an)gen Prior to shipping your an)gen please provide an an)gen submission form with your package, and label each vial sent Pack the an)gen with ice packs or dry ice to maintain proper temperature storage condi)ons Be sure to secure an)gen )ghtly with packing material to prevent damaged vials 12

13 Start of Project Phase IV 13

14 Start of Project AYer the an)gen has been received and payment informa)on confirmed on invoice we will start the project On the day the project starts, a project overview will be sent to no)fy customers that the project has started and confirm the project details is correct 14

15 What is included in the project overview details? Project schedule Date of immuniza)on and method adjuvant used if requested special protocols (immuniza)on loca)on, etc) Date of bleeds taken and es)mated ship date Date of Addi)onal services ordered ELISA, western blots, flow, IHC, Purifica)on, organ harvest 15

16 Phased Approach For custom monoclonal and single domain services, projects are broken into mul)ple phases Each phase can be ordered and invoiced independently 16

17 Monoclonal & Single Domain Phases Mouse Monoclonal Rabbit Monoclonal Single Domain Phase I Immuniza%on Immuniza%on Immuniza%on Phase II Fusion Plasma Cell Isola%on PBMC Isola%on Phase III Subcloning Cloning & Expression Library Construc%on Phase IV Produc%on(Op%onal) Selec%on & Delivery Library Screening Phase V Produc%on(Op%onal) Produc%on(Op%onal) 17

18 Project Troubleshoo%ng If there are any changes to schedule we will no)fy you as soon as possible We will also make recommenda)ons and confirm the next best course of ac)on to be taken at that )me If an)body is not working for the desired applica)on in your hands, let us know and we will provide recommenda)ons to op)mize the an)bodies func)on 18

19 Shipping & Receiving Product Phase V 19

20 Shipping Products Once a bleed is taken it will be processed into serum within 24 hours and shipped according to scheduled dates We will be ship the products using FedEx overnight An no)fica)on of the product being shipped will be sent to confirm the shipment Any data from addi)onal services will also be sent through during this )me(ex ELISA reports, purifica)on reports) 20

21 Receiving Products Upon receiving products a packing slip will be enclosed with the package Packing slip will include the following informa)on All Items shipped Serum volumes from bleeds Dates the procedure occurred A confirma)on from FedEx will be sent to no)fy that the product has been delivered Once products are received the an)bodies are ready to be used 21