Cell line development platform:

Cell line development

The establishment of high-yield and stable cell lines is crucial for large-scale antibody drug production. With rich project experience and complete equipment and facilities, high-quality series services can be provided according to specific customer needs. We have rich experience in mammalian cell expression platforms and have established multiple host cell libraries for the widely used CHO and HEK293 cells, which can meet the different needs of customers.

Ankang Biotechnology has rich experience in mammalian cell expression platforms and has obtained multiple production authorizations for cell lines such as CHOZN, DG44, HD-BIOP3. It has independently developed vector systems such as pRCA single expression box vector and pRCB double expression box vector. With rich project experience and complete equipment and facilities, it can provide high-quality customized services according to customers' specific needs to meet their different needs.

Only the primary protein sequence is needed

Nucleic acid sequence optimization, vector construction, and transient evaluation;

Stable transfection, cell pool screening, monoclonal screening, stability confirmation, and establishment of cell bank;

Experience in developing stable cell lines using monoclonal antibodies, bispecific antibodies, and fusion proteins;

Development and production experience of multiple cell lines including CHOZN, HD-BIOP3, CHO-K1, CHO-S, DG44, HEK293, etc;

300m ² GMP warehouse building workshop, fully automated cell packaging system to ensure the uniformity of the cell bank;

Gas phase liquid nitrogen storage system, 24-hour full monitoring and remote alarm;

A traceable document system that complies with regulations;

Process development platform:

Small scale process development

Various cell culture systems, advanced central control analysis techniques, and rich experience in CHO cell development can tailor suitable processes for customers.  

Based on years of experience in developing cell culture processes, establish a cell culture platform with flow addition and continuous perfusion culture, which can meet the development of culture processes for different types of protein molecules; Mature process platforms combined with advanced central control analysis technology can tailor suitable processes for customers.

Having a team with over ten years of experience in the development of cell culture processes;

High throughput Amber microreactors and multi specification small-scale bioreactors;

Experience in rapid medium screening;

Fully developed process flow for flow addition and perfusion cultivation in all aspects;

Successful cases of technology transfer and scaling up of multiple projects to a commercial scale of 2500L;

We can provide efficient purification process development services for biomolecules such as monoclonal antibodies, bispecific antibodies, and fusion proteins to ensure stable and reliable processes, effectively remove product related impurities, and achieve high recovery rates. Can provide chromatographic packing life verification and purification process characterization research for PC/PV stage.

Screening of high-efficiency chromatography packing materials;

Development and optimization of chromatographic processes;

Development and optimization of virus removal/inactivation processes;

Verification of the lifespan of chromatographic packing materials;

Characterization study of purification process;

Analysis and Quality Research Platform:

structural characterization

By adopting advanced analytical methods and conducting comprehensive analysis of products from physical, chemical, and other perspectives, whether it is characterizing reference materials at different stages, evaluating products from different batches, or conducting comparative studies on biosimilars or improved biologics, it will meet scientific standards and international regulatory requirements.

Peptide level: amino acid sequence, composition, modification analysis, N/C-terminal sequence analysis, N-sugar site/O-sugar site analysis, disulfide bond, peptide map/peptide spectrum, etc;

Protein level: intact molecular weight, deglycosylated molecular weight;

Subunit level: reducing molecular weight, deglycosylation reducing molecular weight;

Advanced structures: UV spectroscopy, fluorescence spectroscopy, Raman spectroscopy, thermal stability, circular dichroism;

Physical and chemical properties research: protein content (extinction coefficient study), amino acid composition analysis, glycated protein, sialic acid content, sugar type (N-glycosides/O-glycosides), free thiol content, size heterogeneity, charge heterogeneity, etc;

Development of analytical methods

As a dedicated analysis team, we always adhere to the principles of analyzing the lifecycle management of methods, whether it is customer transfer methods or internal requirement method development.

Identification detection: isoelectric point detection, peptide analysis;

Molecular weight detection: Full molecular weight study, molecular weight of deglycosylated heavy chains, molecular weight of heavy chains/deglycosylated heavy chains, molecular weight of light chains;

Residual impurity detection: HCP detection and analysis, Protein A residue, host DNA residue;

Protein safety test: endotoxin test (gel method/dynamic turbidity method), sterility test;

Activity detection: ADCC detection, molecular binding activity detection;

stability study

Starting from scientific basis and platform experience, using pharmacopoeia and self-developed and validated methods for physical and chemical analysis, biochemical analysis, and activity analysis, explore the stability of the formulation.

Provide stability testing and storage solution design services, meet all requirements of ICH guidelines, establish and validate stability testing methods according to ICH standards to meet various domestic and international needs;

A professional team is responsible for managing stability projects, providing unified and standardized management standards and high execution standards for all projects based on stability SOPs and plans;

In addition to conventional stability solutions, customized stability solutions can accurately determine the product's shelf life to meet customer clinical research and product quality monitoring needs;

Cell bank assay

The company has established a complete cell bank management system, which undergoes strict verification procedures to ensure that the cell lines in the cell bank can play their expected roles in various applications and meet the requirements of biological agent development.

According to relevant regulations such as ChP, USP, ICH, etc., relevant tests are conducted on various levels of cell banks, production end cells, and fermentation harvest liquids, including:

Cell identification;

Aseptic testing;

Mycoplasma testing;

Uniformity testing;

Detection of intracellular and exogenous viral factors

According to ICH, design a study plan for the stability of cell bank passage, and investigate the stability during cell passage culture, including:

Stability of growth status;

Expression product stability;

Genetic stability;

Compatibility Study

The quality of drugs is not only related to the drugs themselves, but also to the interaction between the packaging materials used and the drugs, which can lead to changes in the effectiveness and stability of the drugs, thereby endangering the lives and health of patients. The State Food and Drug Administration requires drug manufacturers and pharmaceutical packaging material manufacturers to conduct research on the compatibility of drugs and packaging materials to ensure drug quality.

Packaging containers for listed drugs: glass bottles, rubber stoppers, infusion bags, eye drops bottles, aerosol bottles, etc;

Production process components: silicone tubing, filters, gaskets, packaging needles, etc;

Clinical drug delivery device: syringe, infusion set, spray valve, etc;

Information collection and preliminary risk assessment: Conduct scientific risk assessment based on the drug packaging material information, packaging specifications, physical and chemical properties, administration routes, and daily to high dosage provided by the customer, and customize project specific research plans for the customer;

Covering ion strength pH、 Conduct comprehensive extraction research on polarity and other aspects to obtain sufficient and complete extractable materials, helping customers screen for optimal direct packaging materials;

Based on the actual production and development process of the customer, design simulation experiments under extreme conditions to simulate the extractable situation of actual drugs and packaging systems under extreme conditions, providing scientific basis for the selection of migration research detection projects and methods;

According to relevant regulations such as the Chinese Pharmacopoeia and USP, the testing methods are subject to lifecycle management. Methodological validation items include but are not limited to specificity, accuracy, precision (repeatability, intermediate precision), detection limit, and quantification limit;

Safety assessment: Referring to toxicological data provided by TOXNET, FDA, ICH, EMA, etc., the analysis and evaluation threshold (AET) is calculated based on PDE and SCT to evaluate the safety of extractable and leached content results;

Research basis: "YBB 00142002-2015 Guidelines for Compatibility Testing of Drug Packaging Materials and Drugs", "Technical Guidelines for Compatibility Research of Chemical Drug Injections and Plastic Packaging Materials (Trial)", "Technical Guidelines for Compatibility Research of Chemical Drug Injections and Medicinal Glass Packaging Containers (Trial)", "Technical Guidelines for Compatibility Research of Chemical Drugs and Elastic Sealing Components (Draft for Comments)", USP<1663>, USP<1665>, USP<665>, ICH guidelines, etc;