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Upstream & Downstream Process Development

Bioprocess Optimization

Scalable, reproducible bioprocess development that converts biological variability into a controlled manufacturing process with predefined critical quality attributes.

End-to-end process development from clone to purified drug substance
Integrated upstream and downstream optimization to improve yield and product quality
Design-of-experiment and process analytical technology to establish control strategy

Start Your Project

Why integrated bioprocess optimization?

Process scientists and CMC teams need a development partner that understands the interdependencies between upstream and downstream operations to ensure consistent drug substance quality.

Process characterization linking CPPs to CQAs
Harvest quality-driven optimization reduces downstream burden
Defined control strategy suitable for GMP manufacturing

Reproducible

Scalable

Controlled

Our Approach

Integrated Bioprocess Development

We connect clone selection, cell culture optimization, harvest, purification, viral safety, and formulation into a coherent development logic.

Upstream Optimization

Systematic evaluation of seed train, medium, feeding strategy, and bioreactor parameters to maximize viable productivity while maintaining desirable product quality attributes.

Seed train and inoculum density optimization
Medium composition and feeding profile development
pH, temperature, DO, and agitation parameter testing

Downstream Optimization

Development of a robust purification train that maximizes recovery and clearance of process- and product-related impurities across capture, polishing, and formulation steps.

Harvest clarification and primary capture methods
Polishing chromatography (IEX, HIC, mixed-mode)
Viral inactivation and filtration strategy

Quality by Design

Define critical process parameters and establish design space through multivariate studies to ensure drug substance quality is built into the process.

Process Analytics

Apply real-time monitoring and offline characterization (HPLC, CE, LC-MS) to measure product quality, impurity clearance, and process consistency.

Scale-Up Readiness

Deliver a process that is transferable to clinical and commercial manufacturing with defined operating ranges and a demonstrated control strategy.

Deliverables

What You Receive

Comprehensive process development reports and materials to support regulatory submission and tech transfer.

Data Deliverables

Process development report with DOE results and process parameter ranges
Product quality attribute data (aggregates, charge variants, glycosylation)
Impurity clearance profiles and yield summary

Reporting & Support

Control strategy document for regulatory filing
Scale-up recommendations and technology transfer package
Ongoing consultation during process validation and commercial launch

Service Scope

Customizable Project Parameters

Each project is scoped case-by-case to match your molecule, host system, and development stage.

Parameter	Typical Project Scope
Host Cell Line	CHO, HEK293, E. coli, Pichia pastoris, or other systems scoped per project
Culture Mode	Batch, fed-batch, perfusion; bioreactor scale from shake flask to pilot
Medium Optimization	Base medium, supplementation, feed strategy, and carbon/nitrogen balancing
Harvest Method	Depth filtration, centrifugation, or microfiltration; conditioned scoped per project
Capture Step	Protein A, ion exchange, or affinity chromatography as dictated by molecule class
Polishing Steps	IEX, HIC, mixed-mode, or membrane chromatography to meet purity targets
Viral Inactivation	Low pH hold or solvent/detergent; conditions determined by process risk assessment
UF/DF Formulation	Ultrafiltration/diafiltration for concentration and buffer exchange into final formulation

How It Works

Process Development Workflow

A structured, iterative approach from feasibility to scale-up.

Process Baseline & Scoping

Review existing process data, define target product profile, and establish project objectives and timelines in a detailed scoping document.

Upstream Parameter Optimization

Perform DOE runs to evaluate culture conditions such as medium composition, feeding profile, pH, and temperature, identifying critical parameters that affect titer and product quality.

Downstream Purification Development

Screen and optimize capture and polishing steps, including resin selection, gradient conditions, and load challenges, to maximize yield and impurity clearance.

Process Integration & Verification

Combine the optimized upstream and downstream sequences into a complete process run at bench scale to confirm product quality, robustness, and scalability.

Scale-Up & Transfer Support

Develop scale-down models, define operating ranges, and provide technology transfer documentation including process description and control strategy.

Applications

Suitable Therapeutic Modalities

Our optimization services apply to a wide range of biologic modalities.

High-yield mAb processes with defined quality profiles

Platform-based optimization for IgG subclasses, including Protein A capture, low-pH viral inactivation, and polishing chromatography to meet CQAs for charge variants and aggregates.

Fed-batch or perfusion culture optimization
Protein A resin screening and lifetime studies
Polishing step design for aggregate and HCP clearance

Custom bioprocesses for enzymes, growth factors, and cytokines

Host-specific development (E. coli, yeast, mammalian) focusing on expression kinetics, solubility, and post-translational modification control.

Induction strategy and temperature optimization
Refolding or inclusion body processing where applicable
Chromatography selection for high purity and recovery

Scalable production and purification for AAV, lentivirus, and VLP-based products

Upstream cell culture (HEK293, Sf9) and downstream (TFF, chromatography, sterile filtration) optimized for infectious titer and empty/full particle ratios.

Transfection or infection condition optimization
Tangential flow filtration and capture chromatography
AEX polishing to reduce host cell DNA and empty capsids

FAQ

Common Questions

Addressing key concerns before you start.

We apply scale-down models and CFD-guided scale-up principles to translate bench conditions to pilot and commercial scales. Critical process parameters are defined through DOE, and we verify comparability through product quality and yield measurements at multiple scales.
Analytical support includes HPLC (SEC, IEX, RP), CE-SDS, LC-MS for intact mass and peptide mapping, host cell protein ELISA, and residual DNA quantification. Assays are selected based on product-specific CQAs and impurity risks.
Yes, we routinely work with bacterial (E. coli, Bacillus), yeast (Pichia, Saccharomyces), and mammalian (CHO, HEK293) hosts. The optimization approach is tailored to the metabolic and post-translational capabilities of the chosen system.
We start with a detailed technical discussion to understand your molecule, target profile, and development stage. A project-specific SOW is then prepared outlining deliverables, milestones, and analytical requirements. Contact our scientific team to begin scoping.
We can support process improvement for commercial or late-stage programs, provided changes are evaluated for comparability and regulatory impact. Our team will work with you to design a risk-based optimization plan.

Scientific Literature

References

Moreno-Sibaja F, Zou D, Liu S, et al. Microfluidics in biomanufacturing process development. Biotechnology advances. 2025;85:108715. View on PubMed
Gupta R, Arora K, Roy SS, et al. Platforms, advances, and technical challenges in virus-like particles-based vaccines. Frontiers in immunology. 2023;14:1123805. View on PubMed
Perry C, Rayat ACME. Lentiviral Vector Bioprocessing. Viruses. 2021;13(2). View on PubMed
Ozdalgic B, Ustun M, Dabbagh SR, et al. Microfluidics for microalgal biotechnology. Biotechnology and bioengineering. 2021;118(4):1545-1563. View on PubMed
Zampini M, Riva E, Lanino L, et al. Characterization and Clinical Implications of p53 Dysfunction in Patients With Myelodysplastic Syndromes. Journal of clinical oncology: official journal of the American Society of Clinical Oncology. 2025;43(18):2069-2083. View on PubMed
Kim JY, Lee M, Oh S, et al. Acetogen and acetogenesis for biological syngas valorization. Bioresource technology. 2023;384:129368. View on PubMed

Please kindly note that our products and services are for research use only.