Process and Analytical Methods Development
Process and Analytical Methods Development
Cell Culture Process Development

Based on the concept of Quality by Design (QbD), the cell culture process development platform provides optimization of clonal screening, media screening, inoculation density, feeding strategy, and reactor control strategy, to maximize yield and precise control of quality, while ensuring process stability and scalability. In addition to being proficient in fed-batch process development, the upstream process development team is also experienced in intensive process and continuous flow process development.

  • Typical yield of monoclonal antibody by fed-batch process 6-10 g/L (12-15 days)
  • Yield of continuous flow process Up to 120 g/L (24 days)

Clone & Media Screening
  • Start synchronously with CLD to shorten development timeline
  • Screening of imported/local medium
Clone & Media Confirmation
  • Top 2 clone, basal medium, feed medium
  • 3L bioreactor
Process Development & Confirmation
  • 3L bioreactor process development
  • Key parameters: PH, glycan, CEX, SEC, etc.
Scale Up
  • Scale up from 3L to 10/200/500/2000 L
  • Technical transfer

Purification Process Development

The downstream purification team of Aton has rich experience in project development and can customize the purification process according to the product characteristics of customers, to ensure that the purity requirements of the project are met under the premise of high recovery rate and achieve fast process delivery.

  • Robust purification process for monoclonal antibodies and other biologics can be provided within 2~3 months
  • Extensive experience in multi-species global declared virus clearance validation programs
  • Purification process development average recovery rate is 70%

Formulation and Process Development

Aton has an experienced formulation development team with rich experience in liquid and lyophilized formulation products, including monoclonal antibodies, bispecific antibodies, fusion proteins, ADC, etc., can provide comprehensive and rapid formulation development for biologics with robust properties and process scale-up capabilities.

  • Perfect and competitive capability of developability research— based on amino acid sequence and structure modeling, candidate molecules can be evaluated and optimized for development using tools such as CADD and AIDD; meanwhile, verification and screening can be carried out on the established high-throughput experimental platform to improve the success rate of CMC development
  • Comprehensive formulation development platform—supports the development of monoclonal antibodies, bispecific antibodies, antibody fragments, fusion proteins and ADC molecules
  • Can develop high concentration formulations and comprehensive particle identification capability





Analytical Method Development

Aton analytical science team has extensive experience in the analysis and characterization of monoclonal antibodies, bispecific antibodies, fusion proteins, ADC, and other products. Members of the team have participated in the application of more than 20 IND projects and 5 NDA/BLA projects, accumulating a wealth of rich experience in product structure characterization, similarity, and comparability studies, so that comprehensive analysis and testing services can be provided throughout the development, production, and application cycle of biological pharmaceutical products.

  • Support CMC analysis
  • Analytical method development, qualification/validation, and transfer
  • Reference materials characterization
  • In-process control and Batch release
  • Stability study
  • Structure characterization

  • Comparability study
  • Similarity study
  • Support PC/PV analysis
  • E/L

  • Outstanding ability to support process comparability studies at different stages, including early clinical stage, NDA/BLA submission and post-marketing stage
  • Comprehensive similarity research capability, which can meet the requirements of IND and NDA/BLA declaration for different agency including China, US and EU
  • Comprehensive analysis and characterization capability, which can provide analysis and characterization services from CLD to NDA/BLA
  • Comprehensive analytical platform for the analysis and characterization of monoclonal antibodies, bispecific antibodies, antibody fragments, fusion proteins, ADC etc.
  • Strong ability to identify product-related and process-related impurities, with advanced free flow electrophoresis (FFE) equipment, can meet the requirements of complex charge heterogeneity composition study