One-stop Solutions for Biosimilars Development

Biosimilar is a biologic that is almost identical to a previously approved biological product that demonstrates the same clinical safety and efficacy. Their development and evaluation procedures are different from those of chemical generics. Its development involves multiple degrees of intricate, highly controlled manufacturing processes, combined with preclinical structural, biological, and functional assessments, as well as clinical safety and efficacy. Furthermore, to ensure a high level of similarity, a biosimilar undergoes a comparability exercise at every step of the development. At CD Formulation, we focus on the challenges and opportunities of biosimilars and are committed to assisting clients with one-stop solutions for biosimilars development such as drug discovery, screening, optimization and characterization analysis, et.

Our One-stop Solutions for Biosimilars Development Include But Not Limited To:

• Analytical characterization services
  Our expert technical team analyzes and characterizes reference biological through highly sophisticated and innovative analytical tools, which can quickly analyze the key parameters of reference biological and provide important basis for the process development of biosimilars.
• Structural and function confirmation services
  After obtaining the characterization of the reference formulation, our expert technical team develops a manufacturing process that delivers a highly similar therapy, using state-of-the-art biodevelopment technologies and high-sensitivity analytical tools for systematically designing biosimilar molecules to match those identified during the characterization stage quality attributes of the drug, and through continuous optimization processes, a molecular structure that is highly similar to the reference drug is obtained.
• Stability studies services
  Forced degradation, accelerated degradation and other experiments are an indispensable part of the biosimilar process. We have a GMP-compliant stability laboratory to provide customers with stability studies services during the development of biosimilars.
• Biosafety evaluations services
  In vivo activity: measuring therapeutic effect in animals;
  In vitro activity: measuring therapeutic effect in cells: cell proliferation, inhibition of proliferation, cell senescence, measurable changes in cell size or content;
  Enzyme assays;
  Receptor-binding assays;
  Promotion or inhibition of coagulation: chromogenic or turbidimetric techniques.
• Comprehensive PK/PD studies services
  We provide professional PK/PD experimental services, assess the similarities between the biosimilars and reference product profiles by PK/PD.

Advantages of Our Services

• We have professional biosimilars research teams, which can provide one-stop research and full project management services.
• Our one-stop service reduced human resources and operating costs.
• Our one-stop service is convenience and speed, and including all the raw data for subsequent testing and optimization.
• We can achieve competitive pricing, performance advantages and continuous self-improvement in yield.

CD Formulation's business covers all aspects of biosimilars reference analysis, formulation development, ingredients testing, formulation optimization, registration, cooperative production etc. We provide one-stop integrated services from pre-clinical to commercial manufacturing for our global pharmaceutical and biotech partners. In the future, we will continue to strengthen our technological barriers and enhance our R&D production and service capabilities to provide quality and diversified services to more biosimilars development start-ups, medium and large companies as well as pharmaceutical companies around the world. If you have relevant needs, please feel free to contact us!