公司信息

TheraMabs is a leading manufacturing and exporting biopharmaceutical company in therapeutic Mabs and fusion protein products in China. As an innovation-driven and customer-focused company, TheraMabs provides a broad and integrated portfolio of services throughout the therapeutic Mabs and fusion proteins R&D process. Our services are designed to help our customers shorten the discovery and development time and lower the cost of drug and medical device through cost-effective and efficient outsourcing solutions. TheraMabs has successfully established a fully integrated services and technology platform. The company built its initial capabilities around bio-process research, process development services, formulation, and biologics manufacturing services, antibody and biological research reagent manufacturing and sales and regulatory services.

We have provided many excellent products and services to lots of biopharmaceutical companies not only across China but also in many European, American and south-east Asia countries. We are striving to offer all our customers excellent products, considerate services and competitive price. 

TheraMabs offers comprehensive, integrated and open-access discovery, development, manufacturing and testing programs for recombinant proteins and monoclonal antibodies derived  from mammalian cell culture production systems. Our unique single-source  IND-enabling services encompass the entire spectrum of product development–from high throughput monoclonal antibody discovery services to clinical trials.TheraMabs’s integrated expertise and experience can streamline development efforts to achieve a faster time to clinical trials.  Our comprehensive services for mammalian-derived therapeutics – from discovery tocommercialization – including these critical areas: 

MAb Discovery 

Cell Line Development 

Bioanalytical Testing 

Assay Development & Validation 

Cell Line Characterization & GMP Cell Banking 

Process Development & Optimization 

Preclinical Sample Manufacturing 

Viral Clearance / Inactivation Studies 

GMP Manufacturing 

Product Stability Studies 

Benefits 

Established, open-access technology platforms to expedite global regulatory submissions. 

Economical production options for protein therapeutics and biosimilars. 

Comprehensive, integrated, single-source provider for all product development activities. 

Global access to the world’s largest and growing healthcare markets. 

Intimate knowledge of U.S., China and other worldwide regulatory environments,including product
development and approval pathways. 

Program Features 

Strong track record of supporting IND, BLA and market approvals by regulatory agencies
worldwide. 

Experienced and highly trained operational and quality staff with extensive industry experience
in China. 

Dedicated project management. 

Comprehensive quality systems to conduct GLP and GMP programs that meet global regulatory
acceptance. 

Extensive in-life facilities in both the U.S. and China. 

Thousands of commercial product lots and raw material lots released under GMP guidelines or
undergoing stability assessment. 

70-80 cell banks manufactured or characterized each year.