Contract services

Contract services

We provide sample preparation, process development, CMC supports, and performance evaluation of bioprocess product by supporting both microbial and mammalian expression systems.

Sample preparation

Outsourcing sample preparation to YBIRD will be the best choice for facilitating your R&D by eliminating a delay risk of your experiments or evaluation.

We can prepare recombinant protein samples with either microbial cells or mammalian cells in a wide fermentation volume range from bench-scale (150mL flask) to manufacturing-scale (200L for microbial cells and 500L for mammalian cells).

Target recombinant protein-expressing cells that are established and used in laboratories often show low level production of the proteins even though enough amount of high quality samples are needed for further experiments in the pre-clinical proof-of-concept study including safety tests of the proteins, development of analyzing methods of the proteins, etc. The situation may develop a risk of delay of such experiments and of your study.

You can commit your valuable resources to other necessary experiments in your study while we in YBIRD prepare enough amount of high quality samples with consulting the appropriate choice of reagents and materials in the preparation.

Features of our services

  • Microbial cells and mammalian cells
  • Sample preparation with various scale
  • Support for agents and materials in order to achieve an appropriate sample preparation

Process development

We develop appropriate process for commercial production of recombinant proteins based on our experience on many cell lines and recombinant proteins. We support smooth transfer from small lab-scale preparation to large scale for commercial production.

Essential points to develop the process are low cost of the production and robustness of the process that is unsusceptible to the materials and fluctuation factors in the process of the protein. Moreover the product developing schedule and the GMP regulation should be considered in establishing the manufacturing process.

Please contact us even in an early stage of your planning of process development. We will propose a suitable plan to develop a process for manufacturing your product candidate.

Features of our services

  • Proposal of a process in consideration of commercial production
  • Proposal of a process development to reduce the production cost(raw materials, simplification of process)
  • Proposal of a robust process which can be easily managed

CMC supports

We provide CMC (Chemistry, Manufacturing and Controls) data for an optimal manufacturing process. It is essential for such process to assure the consistency of physicochemical data (purity, impurity, structure, stability, etc.).

CMC data are necessary in most of the CTD (Common Technical Document) for the marketing authorization of biopharmaceuticals. The high quality data have to be produced promptly to apply for approval of your product. However, you may sometimes have difficulties to get CMC data only in your company or organization because of your outsourcing in many steps of the process.

We support you by proposing an appropriate experiment plan and protocol to acquire CMC data from our accumulated information and technique.

Features of our services

  • Providing physicochemical data (purity, impurity, potency, stability)
  • Providing high quality data to guarantee product
  • Proposal of the experiment plan to obtain high quality data

Performance evaluation of bioprocess products

We can evaluate the performance of apparatus and materials for bioprocess under development because we have used many bioprocess products in daily works and are able to prepare biopharmaceutical candidate samples in a large scale in YBIRD.

Evaluation of apparatus or material prototypes at a mostly actual scale is essential for developing such products either in the planning of the product development strategy or in the basic data acquisition. Then you may need to use a large-scale production facility, certain protein-producing cells, etc. for the evaluation of the prototypes.

We propose appropriate plan of the evaluation of your prototypes in a bioprocess, and provide assured evaluation data.

Features of our services

  • Performance evaluation at the almost actual scale
  • Performance evaluation of the materials related to bioprocess products
  • Proposal of the experiment plan to evaluate the performance

GMP production

under construction

Service flow

  • Customer

    Customer

  • YBIRD

    YBIRD

Inquiry

Non-Disclosure Agreement

Meeting

Estimate

Conclusion of contract

Fermentation, Purification

Delivery

Inspection

Technical Transfer (if necessary)

We will propose suitable solutions to customer's requests.
Please contact us first.

Consultant: Daisuke Arinobu, Ph. D

Daisuke Arinobu, Ph. D

Production either by microbial cells or by mammalian cells and production in a wide range of fermentation of either type of cells are available in YBIRD for evaluating your developing products.
Please feel free to contact us about any concern you have.