Cell Line Engineering Platform
CMC Development Platform
Media Manufacturing Platform
Clinical Sample Production Platform
Research Material Preparation
We prepare antibodies, Fc fusion proteins, and other recombinant proteins for research use with various hosts inflexible culture volumes. High-purity and low-endotoxin proteins with titer > 1g/L can be delivered within 6-12 weeks for in vitro, in vivo and developability research.
- Transient transfection vector construction
- High-throughput transient expression selection
- Large-scale transient expression and purification
- Stably transfected cell pool expression and purification
Expression System E.coli, HEK293, HEK293F, CHO-S, CHO-K1 Transfection Method PEI, Lipofectin Transfection, Electrotransfection Culture Volume 125mL Erlenmeyer Flask~15L Bioreactor Purification System Affinity Chromatography, Ion-exchange Chromatography, Hydrophobic Interaction Chromatography, Molecular Sieve Chromatography Assays SDS-PAGE, HPLC-SEC, IEC, WB, Ortebio, UV Spectrophotometry, Biochemical, and Endotoxin Analysis
Test Cell Construction
We construct standard parental cell lines from different sources for development test or candidate drug assessment. Expression vectors with different tags can be used for expression verification. We can also develop monoclones and further optimization following the process of developing stable cell line for production, and therefore acquiring stable and sustained expression of target protein. Along with our QuaCell® media and corresponding reagents, this system turns into a high-efficiency tool of drug screening and in vitro drug effect evaluation.
Host Cell HEK293, HEK293T, CHO-K1 or Customer Designated Cells Plasmid Vector pKS001, pcDNA3.3, pLEX or Customer Designated Plasmids Tag V5, c-myc, Flag, His Transfection Method PEI, Lipofectin Transfection, Eelectrotransfection
Cell line Suspension Adaptation
Based on our in-depth understanding of medium component, we build a traceable cell suspension adaptation platform. We can adapt common industry adherent cells to suspension culture system, facilitating scale-up production for antibody drug expression, vaccine production, virus packaging, etc.
Serum-free suspension adaptation
Low-serum suspension adaptation
Suspension medium switching
Stable Cell Line Development
Stable cell line is used in recombinant protein and monoclonal antibody production, assay analysis, gene editing, functionality research, etc. QuaCell® stable cell line construction service constructs high-expression and stable cell lines with our cell platform technology, improving your experiment outputs efficiently. Our one-stop service integrates all experimental steps and provides complete experiment records and document for regulatory authorities.
Gene engineering and vector construction
Transient or stable expression assessment
Stable expression cell line construction
Monoclone selection on quality and titer
Cell line passage stability assessment
Original recording documents and application materials preparation
Host Cell CHO-K1Q or Customer Designated CHO Cells Plasmid Vector Exclusive Plasmid (pKS001) or Customer Designated Plasmids Delivery Cycle 90~120 Workdays (from DNA to 3~5 Optimal Monoclones) Titer 2.5~3.5 g/L (Monoclone) Maximum Titer ＞8 g/L Auxiliary Device Monoclone Printer、Monoclone Imager、High-throughput Bioanalyzer、HPLC、UPLC-MS、Fortebio、CE
QuaCell® R&D team, with over 15 years of medium formula developing experience, provides multiple cell culture medium development services as per customer requests. Patented High-throughput screening (HTS) technology identifies the best fitting medium formula at a fast pace. Considerations of powderization and ease of use are incorporated in the early stage of development, ensuring large-scale production delivery in future.
- CHO base medium development
- CHO supplemental feed development
- Other suspension cell medium developments
Host Cell K1、K1-SV、CHOZN、CHO-S、DG44、DUXB11 or Any stable transfected cells / host cells that customer designated Delivery Cycle 18~38 Weeks Resident Personnel Flexible Formulation Delivery Flexible Medium Delivery Flexible，with GMP Seamless Supply Solution Auxiliary device Quality Cell Screening System、2L High-through parallel reactor system
Product Quality Characterization
In order to cooperate with the development and optimization of culture technology, we also carried out a series of detection and analysis of monoclonal antibody and protein drug quality. This kind of project can assist the development and optimization of culture medium, and can also be split to provide a single independent service.
Protein Quantification：UV Spectrophotometry, HPLC(Protein A), Fortebio
Activity Assessment：Cell Assessment, ELISA, Fc Function Analysis
Physico-chemical Analysis：Aggregate(SEC), Particle(CE-SDS), Charge Variant(IEX)
Molecular Characterization：Molecular Weight(LC-MS), Peptide mapping(HPLC), Glycan analysis(UPLC)
Product Titer Enhancement
Optimization service aiming to enhance titer is available for projects with preliminary process development. Based on DoE data, we explore cell line potential and improve protein titer by replacing/adjusting medium and/or supplement feed, increasing/decreasing specific medium component, adjusting process parameters, etc.
- Base medium optimization
- Supplement feed optimization
- Supplementation strategy and process optimization
Product Quality Optimization
Product quality attributes can be optimized from the aspects of medium and process parameter. By crossing the culture data with the QuaCell® project database to identify potential critical factor, and validating with PB or RS model of DoE, we can reach the goal of optimizing product quality.
- Aggregate regulation
- Charge variant regulation
- Glycosylation optimization (G0F or other type of glycosylation)
- Sialic acid quantity optimization
- ADCC/CDC activity optimization
Pilot Scale Study (follow QbD)
QuaCell® team can help you build qualified scale-down models from scratch with extensive medium and supplemental feed development and 1000L+ bioreactor culture experiences. We provide services in specific cell line culturing, growth condition optimizing, supplementation strategy constructing, stability verifying, and cell titer improving.
- Scale-up process optimization and validation
- Critical material attribute design space determination in production
- Critical process parameter design space determination in production
- Critical quality attribute risk assessment
- Scale-down model qualification
- Other scale-up process optimizable projects
Medium Powder Custom Manufacturing (GMP/ non-GMP)
Manufacture deviceQuaCell® manufacturing department processes and produces customers’ formulations by GMP raw material quality management standards, ensuring the effective components of the formulations and their concentrations are within acceptable ranges, which are verified by production validation processes.
- Customized formulation contract manufacturing
- QuaCell® formulation customized manufacturing
- Standard formulation special customized manufacturing
Single-batch Capacity Flexible within 2~300 kg Manufacture Device Imported Pin Mill, Closed Nitrogen Protecting System, Online Critical Attribute Control Auxiliary Service Free Formula Assessing Service, Complete Raw Material Selection Solution, Stable Parameter Control System, Robust Scale-down Model Quality Assurance Component Integrity Assurance, Product Uniformity Assessment, Trace Element Variability Control Delivery Cycle As fast as 10 workdays within China and 4 weeks outside
Liquid Medium Custom Manufacturing (non-GMP)
We also produce custom liquid medium and do sterilizing filtering and bottling according to customers’ formulations by the standards of GMP’s raw material quality management.
Powder Manufacture Scale-up Validation
We design and evaluate powder formulation and liquid formulation powderization, utilizing as small as 2 kg scale-down model to test production solutions with controllable production cost. Along with your scale-up powder production and fermentation/culture, we provide a full set of validation supports to ensure future production delivery.
- Liquid formulation powderization design
- Powder/liquid uniformity evaluation
- Powder formulation stability evaluation
- Powder production stability evaluation
- Satellite bioreactor delivery validation
GMP Seamless Supply Solution
As per pharmaceutical companies’ specific requests, we provide custom GMP compatible packaging and supply solutions for large scale GMP medium delivery, to improve convenience, reduce safety risk and enhance production efficiency.
- Customized material code
- Customized packaging service
- Medium liquification module facilities support
- DMF Access
Preparation of Clinical Raw Materials
QuaCell®clinical sample production facilities and plants are designed and constructed based on cGMP requirements of the United States, the European Union and China. The production facilities and workshops can provide production services for the project. At present, we have a complete production line, including independent cell expansion, cell culture and purification areas (including the downstream process areas before and after virus treatment). In the whole upstream and downstream process, disposable / disposable technology is adopted.
- Fed batch culture 50 ~ 200L
- Special HVAC system
- GMP warehouse
- Standby diesel generator
- UPS power supply for key equipment and instruments