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Recombinant Proteins

The field of recombinant proteins – including monoclonal antibodies – production has been largely developed in the past decades. Applications of these proteins are various and address different pathologies. Among the therapeutics, recombinant antibodies produced using engineered CHO (Chinese Hamster Ovary cells) are definitely key tools to fight against tumor cells in humans in addition to chemotherapy or radiotherapy.

Clean Cells, with its extensive regulatory knowledge and GMP certifications, has a long history of working with the recombinant protein and monoclonal antibody industries. Our Company offers a wide range of relevant services for protein manufacturers, including cell bank production and storage, characterization and testing of products all along protein manufacturing et purification process.

Cell banking

Clean Cells has a wealth of expertise in cell culture for biomanufacturing and quality control purposes, both in R&D and in GMP-compliant settings. The company offers advanced recombinant protein related services which include mammalian cell bank manufacturing to support research and development (R&D) and GMP processes together with complete characterization of banks.

Cloning selection

According to authorities’ expectations, Clean Cells has implemented a state-of-the art platform for cloning. This service allows the selection of the most potent clone – for both a good growth and a high expression of the protein of interest – and ensures a suitable stability of the production yields.

Biologics testing

As market leader, the company has a proven cGMP expertise and its team has developed and validated a multitude of assays to ensure the safety and characterization of the whole range of recombinant products and monoclonal antibodies.

With its extensive experience in the quality control of recombinant proteins, Clean Cells is a trusted authority in biologics biosafety testing: detection of bacteria, yeast, fungi, mycoplasma, virus and retrovirus detections according to international regulatory requirements (European and US pharmacopoeias, FDA….) in every step of the production of a drug product.

	Raw materials	MCB	WCB	PPCB*	UnpB*	DS	DP
Genetic Identity		•	•	•
Genetic Stability (i.e Gene Copy Number)		•	•	•
Sterility/Bioburden	•	•	•	•	•	•	•
Mycoplasma detection	•	•	•	•	•
Endotoxins detection	•						•
Adventitious agent detection (in vivo & in vitro testing)	•	•	•	•	•
Bovine & procine in vitro virus testing (depending of raw materials)	• 9CFR	•		•
Retrovirus detection		•		•	•
Virus detection by Transmission Electron Microscopy		•		•	•
Species-specific virus detection		•		•	•
MAP (Mouse Antibody Production) HAP (Hamster Antibody Production)		• •		• •	• •
Impurities: host-cell proteins & host-cell and vecto DNA						•	•

(*) PPCB = Post Production Cell Banks
(*) UnpB = Unprocessed Bulk lots

Besides biosafety testing, expectations raised from authorities for accurate potency assays allowing inter lots comparison and suitable release specification of final products before use in patients. In line with this growing requirement, Clean Cells also developed specific bioassays for the screening, evaluation and GMP testing of mAbs potency through innovative ADCC methods, with a proprietary effector cell model and a patented cold read-out.

Custom analytical development

Thanks to its different experts in the field of molecular assays (PCR, NGS), bioassays, immunoassays and cell culture, our company is able to design and develop tailored services necessary for a full characterization of certain recombinant products and antibodies.

In addition, Clean Cells offers support for the qualification and validation of analytical methods, which may involve transferring methods in-house, conducting initial qualification, or fully validating methods in accordance with cGMP and ICH Q2R2.

Storage

Cell banks are a critical component in the production process of recombinant proteins and monoclonal antibodies. Our integrated services include cell bank storage solutions to ensure the security and stability of R&D and GMP materials.

Our dedicated and secure areas feature 24/7 surveillance of storage spaces to provide the highest level of protection for your valuable materials.

Leaflets

Leaflet

CHO-Derived Products Leaflet

Leaflet

ADCC Effector Cells Leaflet

Download via media library

For more information on the full range of protein dedicated services applicable to your product, please do not hesitate to contact us.

For any need of process development and batches for phase 1 and 2 of clinical trials, feel free to contact our partner Biodextris: https://www.biodextris.com/

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