These are the key steps in developing a close working partnership with you, our customer:
Mutual Confidentiality Agreement - This agreement will cover the exchange of confidential information regarding your documents, materials and processes used by Avid Bioservices.
Questionnaire - We pride ourselves in operating and maintaining a high level of compliance required of a multi-product facility. Completion of the questionnaire together with access to the customers Material Safety Data Sheet will help us determine the most appropriate procedures for the safe handling and processing of the material.
Technical Discussion - The results of any pilot or feasibility trials are reviewed to ensure agreement is reached on the final specification.
Project Proposal - Upon receiving a request for proposal (RFP) a price quotation will be proposed upon evaluation of your process requirements.
The Proposal Process - may contain all or part of the following steps:
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Summary and evaluation of the customer current process
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Media screening program and cell adaptation
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Development of master and working cell banks
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Cell culture development and scale-up processes
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Purification method development
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Shakedown manufacturing runs
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cGMP Manufacturing
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Viral clearance studies
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Quality Systems review
QA Qualification Audit by Customer - The customer is encouraged to visit Avid Bioservices to perform an audit of procedures and the facility.
Quotation - A price quotation is based upon evaluation of your process requirements.
Contract Agreement & Reservation - Upon agreement of the quotation, a contract is developed and manufacturing time reserved.
Technical Transfer - Full process transfer reports with bioreactor conditions and purification methodology are available for submission to regulatory authorities.
Pilot Studies - This can be the bioprocessing of small quantities of material in order to determine or verify productivity and growth characteristics and whether the desired specifications can be achieved. If it is a new clone without a previous history of growth and productivity in bioreactors, pilot studies are generally required to verify or optimize conditions.
Manufacturing - Product is manufactured in one of four bioreactors and is purified to the degree specified in the Contract Agreement. The choice of bioreactor size is determined by the quantity of material required.
Shakedown Runs - Used to verify all parameters prior to cGMP manufacturing. It is also an important step to ensure personnel are trained in all related SOP's prior to initiating any cGMP runs.
Testing & Delivery - Product meets final specifications and is released. Product is shipped via previously approved schedule and method.
Communication At Each Step Provides Assurance Of Project Status
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