Cell line development (CLD) is a crucial process in the CMC (Chemistry, Manufacturing, and Controls) development of biologics, directly influencing both productivity and product quality. Special attention must be given to creating robust, clonally-derived manufacturing cell lines, as this step is critical for a smooth CMC process and cost-effective commercial manufacturing. Aton Biotech offers mammalian CLD services for biotherapeutics as a standalone offering or as part of our integrated CMC biologics development, empowering clients' projects with high efficiency and strict quality compliance.

Aton upstream process development platform is based on the Quality by Design (QbD) concept. The main team members come from well-known domestical and international pharmaceutical companies. With years of experience accumulated in biopharmaceutical field, we focus on developing robust and scalable processes, and providing a range of services including process development, quality related process optimization and process characterization. We commit to provide professional services and effective solutions for our clients.

 

• Mature Platform based on CHO-K1

  The cell line developed by Aton could be used to identify keystones and major challenges of process development in early stage of projects.

• Database of Mainstream Chemically Defined Media

  With the established medium database, suitable medium can be selected in early stage of process development, and process can be further developed and confirmed at 2 L and 10 L. The whole duration of development is 8 ~ 12 weeks. 

• High Quality Technology Transfer Platform

  The tech transfer platform established by Aton experts closely integrates the R&D and production teams. In tech transfer, we always commit to the principle of beginning with the end in mind. 

  Production and process development stages are effectively integrated by guiding design of process development with the needs of production, eliminating the need of additional process transfer and saving time cost for customers.

The downstream process development team at Aton comprises technical experts with extensive experience in manufacturing, specializing in early process development, process optimization, process characterization, technology transfer, and process validation. Our downstream process platform has handled various products, including monoclonal antibodies, bispecific antibodies, fused proteins, and antibody fragments, providing clients with integrated purification solutions and customized development services for specific products.

 

• Monoclonal Antibody

  Relying on the mature process platform established by Aton and extensive experience of technical experts, a robust and scalable purification process development can be completed within 1 to 3 months for typical purification procedures, including clarification filtration, affinity capture, virus inactivation, chromatographic polishing, viral filtration, and ultrafiltration/diafiltration unit operations, along with the completion of process tech-transfer.

• Non-monoclonal Antibody

  The downstream process team at Aton also has extensive experience with non-monoclonal antibody products. We have developed a dedicated purification process for non-monoclonal antibody using high throughput screening methods for resin and filtration membrane.

The formulation development team at Aton has extensive experience in liquid and lyophilized monoclonal antibodies, bispecific antibodies, fused proteins, ADCs, and more. We offer comprehensive and rapid formulation development for various biologics, providing robust prescriptions and scalable formulation processes.

 

• Comprehensive Drugability Research Capability

  Based on amino acid sequence and structure modeling, we will assess and optimize candidate molecules with tools such as CADD and AIDD. Further validation and screening will be conducted on an established high-throughput platform to ensure the success of CMC development.

• Comprehensive Formulation Research Platform

  With capabilities for high concentration formulation development and comprehensive particle identification, our platform supports the formulation development of various biologics, including monoclonal antibodies, bispecific antibodies, antibody fragments, fused proteins, and ADCs.

Aton Biotech analytical science team has extensive experience in the analysis and characterization of monoclonal antibodies, bispecific antibodies, fusion protein, ADC and other products. The team have participated in more than 70 IND projects and 10 NDA/BLA projects, and accumulated rich experience in product structure characterization, similarity and comparability studies, so that comprehensive analysis and testing services can be provided throughout the biologics product development life cycle.

 

• Outstanding Ability to Support Process Comparability Studies at Different Stages

  Including early clinical stage, NDA/BLA submission and post-marketing stage.

• Comprehensive Analysis and Characterization Capability

  Phase-appropriate analysis and characterization services from CLD to NDA/BLA.

• Comprehensive Impurity Profiling Capability

  Identify product and process-related impurities.

• Comprehensive Capability of Similarity Study 

  Meet the requirements of IND and NDA/BLA submission at different agency including FDA, EMA and NMPA.

• Comprehensive Analytical Platform

  Analytical strategy for mAb, bsAb, antibody fragment, fusion protein, ADC, etc.