Aurigene offers upstream process development services for biologics programs across different stages of development. Our teams support clients with cell line development, process optimization, process intensification, and scale-up planning for a range of recombinant biologics.
We work across mammalian and microbial systems and support molecules such as monoclonal antibodies, bispecific and multispecific antibodies, Fab fragments, ScFv, and proteins. Our aim is to help clients build upstream processes that are robust, scalable, and aligned with later manufacturing needs.
Our Custom Services
- Cell line development
Supports biologics programs through pool generation, clone selection, characterization, and stability analysis using established mammalian expression workflows. - Stable pool development
Includes stable pool generation and evaluation, with the deck indicating a typical timeline of 10–12 weeks for this stage. - Monoclone generation and characterization
Uses CellCelector Flex for monoclone generation, followed by characterization and stability assessment across generations. - Transient expression analysis in CHO cells
Enables early expression assessment in CHO cells to support candidate evaluation and upstream decision-making. - Shake flask fed-batch evaluation
Performed in controlled conditions of temperature, CO2, and humidity to assess productivity and process behavior. - Batch mode process development
Supports upstream development in batch mode for recombinant biologics as part of the broader process development offering. - Fed-batch process development
Includes fed-batch process design and optimization, a key operating mode highlighted in the deck for biologics development. - Perfusion process development
Covers perfusion-based upstream development, including process intensification strategies where suitable for the molecule and program stage. - Process intensification and concentration studies
Includes N-stage and N-1 stage intensification approaches to improve upstream productivity and support transition toward manufacturing. - Cell bank preparation and characterization
Supports preparation and characterization of cell banks as part of development readiness and continuity into later stages. - Developability and manufacturability evaluations
Helps assess how well a molecule and process are suited for scalable development and future manufacturing. - IND-enabling and standalone module support
Supports both integrated IND-enabling programs and standalone upstream modules depending on client requirements.
Expression Systems and Modalities
Our upstream process development services support multiple host systems and biologic formats.
Expression systems
- CHO
- HEK293
- E. coli
Modalities
- Monoclonal antibodies
- Bispecific antibodies
- Multispecific antibodies
- Fab fragments
- ScFv
- Proteins
- Complex biologics
These capabilities allow us to support different molecule classes with development strategies suited to their expression and manufacturing needs.
Cell Line Development Capabilities
Our cell line development workflows are designed to support progression from pool generation to clone selection and characterization. The deck supports capabilities such as pool generation and characterization, monoclone generation using CellCelector Flex, monoclone characterization, and stability analysis.
The platform also includes transient expression analysis in CHO cells, optimized transfection conditions, signal peptide optimization for higher titer expression, and stable pool generation using electroporation-based workflows. In addition, shake flask fed-batch evaluation is performed under controlled environmental conditions.
Upstream Process Development Capabilities
Our upstream process development team supports different operating modes, including batch, fed-batch, perfusion, and process intensification. The focus is on building practical processes that support productivity, consistency, and future scale-up.
The deck also shows infrastructure support through AMBR systems, small bioreactors, single-use 10 L and 50 L systems, and pilot plant 200 L capabilities. This helps programs move from early development studies toward larger-scale process readiness.
Infrastructure and Capacity
Our upstream development infrastructure supports flexible execution across different development needs. Available systems and capacities highlighted in the deck include:
- AMBR systems
- Small bioreactors (5/10 L)
- Single-use 10 L systems
- Single-use 50 L systems
- Pilot plant 200 L systems
- Expandable R&D and manufacturing capacity
This setup supports data generation, reproducibility, and smoother transition into later development and manufacturing stages.
Why Aurigene Upstream Process Development Services?
Support across mammalian and microbial expression systems
Experience across multiple biologic modalities
Capabilities spanning cell line development and upstream process development
Flexibility in batch, fed-batch, perfusion, and intensification approaches
Infrastructure that supports development through scale-up
Integrated biologics environment with links to analytical, formulation, tech transfer, and manufacturing capabilities
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Learning Resources
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