TheraMabs have Thermo Q-Exactive Mass spectrometer, Shimadzu LC20A liquid chromatograph, SpectraMax M4 multiscan spectrum, Bio-Rad SYSTEM GelDoc XR+, TY10165-4000 PROTEAN IEF System ZX21, Quant Studio 6 Flex Real-Time PCR System and other advanced equipment and has rich experience of research ecialist staff engaged in the development of analytical methods, We can provide all-round testing services from product development to commercialization.
Our services include:
Assay Development
Stability Studies
Assay Development
TheraMabs has successfully developed hundreds of assays for various types of analytical bioassay or biosafety testing purposes throughout the establish-ment of the cell lines, cell suspension culture, purification, preparation, production and testing of reference standard,which are developed and validated for the semi-finished products，bulk，final product.
Our services include:
(1) protein quantification (protein concentration by UV280).
(2) biological activity (Cell-based or ELISA binding activity).
(3) physical properties (purity, polymer, charge isomer, isoelectric point, appearance, pH value, osmotic pressure).
(4) impurities (host cell protein residue, protein A, DNA residue, endotoxin and sterility).
(5) biochemical and physical characterization (molecular weight under reducing and non-reducing, peptide mapping analysis, primary sequence analysis, Glycan profiling).
(6) cell bank detection (sterility, mycoplasma, cell line identification, cell morphology and growth characteristics, exogenous factor detection).
Stability Studies
TheraMabs can design and implement comprehensive stability storage solutions to meet regulatory and client requirements. All temperature and humidity conditions that meet the ICH guidelines can be provided.
Storage Conditions
（1）2-8℃
（2）25±2°C/60±5%RH
（3）30±2°C/65±5%RH
（4）30±2°C/70±5%RH
（5）40±2°C/75±5%RH
（6）-20±5°C
（7）-40±10°C
（8）-80±10°C
（9）Liquid Nitrogen
Development Stability Assays
The design of stability programs includes the process of selecting the most appropriate stability-indicating assays and the rationale for those choices. Test articles can be subjected to various conditions to induce product breakdown, such as high temperature, high humidity, oxidation, reduction, The following methods are commonly used as stability indicating methods including SE-HPLC, IEX-HPLC or CIEF, CE-SDS (or SDS-PAGE). In addition, TheraMabs can also provide sterility, endotoxin, pH value, appearance, insoluble particle, osmotic pressure and other methods.
Lot Release Testing
TheraMabs’ lot release program offers a high-quality comprehensive selection of assays and methodologies for determination of product potency, purity, identity, concentration/titer and biosafety(GLP or GMP). TheraMabs s in-house QC lot release program covers all stages of product manufacturing including:
(1) cell harvest solution.
(2) Bulk Product.
(3) finished product.
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