We specialize in delivering end-to-end mammalian protein process development services, enabling the seamless transition of biologics from discovery to commercialization. We optimize expression systems, upstream/downstream processes, and analytical strategies to meet global regulatory standards. Our solutions are tailored for scalability, reproducibility, and cost-efficiency, ensuring clients achieve robust clinical and commercial outcomes. Explore our comprehensive CDMO Solutions and dedicated Mammalian Protein CDMO Services.
Overview of Mammalian Protein Process Development
Mammalian protein production is pivotal for complex biologics like monoclonal antibodies, enzymes, and fusion proteins due to their requirement for post-translational modifications. Process development involves designing and refining workflows to maximize yield, purity, and functionality while adhering to stringent quality guidelines. Critical stages include cell line development, upstream process development, downstream process development,formulation development, etc. We provide end-to-end mammalian protein process development servicesby integrating cutting-edge technologies and risk-based approache.
Our Services
Cell Line Development and Engineering
We employ high-throughput screening and genome editing to generate stable, high-producing CHO or HEK293 cell lines. Our platforms prioritize clones with optimal growth kinetics, product titers, and post-translational modification fidelity. Proprietary vector systems and selection markers enhance the efficiency of transfection.
- Cell Lines: CHO-S, CHO-DG44, HEK293, HEK293T, SP2/0.
- Methods: Stable transfection (lipofection, electroporation), gene editing, transposon systems, promoter optimization, selection markers (glutamine synthetase, DHFR).
Upstream Process Optimization
Our upstream services focus on maximizing protein yield through advanced fed-batch and perfusion bioreactor systems. Media and feed formulations are customized using design-of-experiments (DoE) methodologies to balance nutrient availability and metabolic waste. Real-time monitoring via process analytical technology (PAT) ensures consistent cell viability and productivity across scales.
- Culture Systems: Fed-batch, perfusion, continuous manufacturing.
- Bioreactors: Stirred-tank reactors (STR), wave bioreactors, single-use bioreactors (SUB).
- Media & Feed: Chemically defined media, protein-free formulations, metabolic flux analysis, DoE-based optimization.
- Monitoring Tools: pH/DO probes, online biomass sensors, metabolite analyzers.
Downstream Purification
We design purification trains integrating affinity chromatography, ion exchange, and hydrophobic interaction chromatography (HIC) to achieve >98% purity. Viral clearance validation, including nanofiltration and low-pH inactivation, aligns with ICH Q5A guidelines. Continuous processing and single-use technologies minimize cross-contamination risks while improving cost-effectiveness.
- Chromatography: Protein affinity, ion exchange, mixed-mode chromatography, hydrophobic interaction (HIC), multimodal resins.
- Filtration: Tangential flow filtration (TFF), depth filtration, virus-retentive nanofiltration.
- Viral Clearance: Low-pH hold, solvent/detergent treatment, UV-C inactivation.
Formulation and Stability Studies
Our team develops lyophilized or liquid formulations optimized for pH, excipients, and osmolality. Accelerated stability studies under ICH conditions (e.g., 25°C/60% RH or 2–8°C) predict shelf-life and degradation pathways, supporting robust regulatory filings.
- Formulation Types: Lyophilized powders, liquid formulations (buffers: phosphate, citrate, histidine).
- Analyses: Forced degradation studies, subvisible particle counting, DSC (differential scanning calorimetry).
Frequently Asked Questions
Q1: How do you handle proteins prone to aggregation or low solubility?
We employ formulation screening (e.g., excipient compatibility studies) and adjust purification conditions (e.g., buffer pH/additives) to stabilize proteins. HIC or TFF steps may also be incorporated to remove aggregates.
Q2: How do you balance cost efficiency with product quality during process development?
We employ quality by design (QbD) principles and design of experiments (DoE) to identify critical process parameters that impact both cost and quality. By optimizing media utilization, reducing purification steps through integrated chromatography strategies, and implementing single-use technologies.
Q3: Can you accommodate custom requirements for niche or novel protein therapeutics?
Yes. Our platforms are adaptable to unique molecular characteristics, such as fusion proteins, bispecific antibodies, or proteins requiring non-standard glycosylation. We tailor cell line engineering, culture conditions, and purification steps to align with specific stability, activity, or scalability needs.
Our products and services are for research use only.
