The Services of Bio Elpida in R&D and Feasibility Study
Logical progression from project definition to early development stage
Bio Elpida offers a
broad spectrum of research and development services using state-of-the-art cell culture technologies including:
- Cell isolation
- Immune therapy
- Cell therapy
Depending on regulatory and partners' requirements, we concentrate on the
feasibility and development of Innovative processes, Immunoassay and Biomarkers. With such requirements defined, Bio Elpida will work under the following R&D and Feasibility steps:
Project Definition
During this preliminary phase, under a CDA, you will present and define your project to Bio Elpida including: your objective, the deliverables, the description of the technology… Bio Elpida will provide you with a specific proposal including a complete presentation of the company and our capability.
Proof of Concept Evaluation
Following the presentation, Bio Elpida will evaluate with your collaboration, the preliminary results you had obtained. Bio Elpida will propose you technical solutions to adapt your project according to your expectations, taking into account the industrialisation requirements and complying with regulatory.
Program Development
Bio Elpida will provide you with a "master services agreement" covering services to be delivered to manage your project including a schedule for the specific R&D and feasibility steps.
Research & Development
This phase is dedicated to test the different solutions imagined during the evaluation and proposed in the development program. After this R&D step, the best solution will be proposed according to the parameters defined in the development program.
Feasibility Study
The aim of this step is to confirm the solution selected during the R&D step according to a defined protocol. The results of this study are registered in a formal report that anticipates the pharmaceutical development procedures.
Pre-validation
Pre-validation consists in repeating the feasibility study according to batches requirements and GMP conditions. Pre-validation is performed in a non-pharmaceutical zone. Batches produced are controlled according to methods defined at earlier steps and allow validation of the analytical methods. These batches can be used for pre-clinical studies as they perfectly reflect future clinical batches.
