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About Us
Pioneering Biopharma With Purpose.
At Glogene, we are redefining biopharmaceutical development through cutting-edge science, deep domain expertise, and agile execution. As a trusted partner to biotech pioneers and global pharmaceutical companies, we deliver customized, end-to-end solutions that accelerate the journey from Discovery to Commercial launch
Our Promise
• Innovation-driven solutions tailored to your molecule.
• Seamless integration across development and manufacturing
• Commitment to quality, compliance, and operational excellence
Our Focus Areas
• Cell Line Development & Engineering.
• Analytical & Characterization Services
• Process Development ( Upstream and Downstream)
• GMP Manufacturing
What Sets Us Apart
- End-to-end CDMO capabilities
- Strong foundation in Quality by Design (QbD) and regulatory compliance.
- Expertise in complex biologics including mAbs, fusion proteins, and bispecifics.
Bioanalytical Services
Anti-drug antibody (ADA) testing and neutralizing antibody (NAb) assays
From early-stage cell line engineering to GMP manufacturing, our platform is built for speed,
flexibility, cost-effectiveness, and scientific excellence, allowing our partners to accelerate
programs without compromising on quality or compliance.
PK/PD & Immunogenicity Assays
• Fit-for-purpose and GLP-compliant method development
• Ligand binding assays (ELISA, MSD, Gyrolab)
• Cell-based functional assays for bioactivity
• Anti-drug antibody (ADA) testing and neutralizing antibody (NAb) assays
Support Across Preclinical to Late-Phase Trials
• Nonclinical and clinical sample analysis
• Data packages tailored for regulatory submission
• High-throughput capabilities and rapid turnaround
our Services
Accelerating Discovery Through
Expert Services
Our upstream process development is designed to support all stages of the product lifecycle—from early-stage cell line evaluation to GMP manufacturing readiness. With deep expertise in Fed-Batch, Intensified process, Perfusion process.
From initial clarification to final formulation, our scientists develop scalable, phase-appropriate purification processes tailored to your molecule — monoclonal antibodies, recombinant proteins, vaccines, or novel modalities
Accelerate your timeline and improve yield with our continuous processing platform. Whether you're adopting perfusion upstream strategies or transitioning from batch to continuous mode
Risk-based and data-driven approaches, such as Design of Experiments (DoE) and multivariate data analysis (MVDA), are employed to elucidate the relationship between process parameters and product quality.
Processes are developed with scalability and regulatory readiness in mind, ensuring a smooth path from early development to GMP manufacturing.Scalable platforms from benchtop to pilot and GMP scale.
Analytical Services
End-to-end analytical support for biologics development and manufacturing
We provide comprehensive method development, qualification, and routine testing services to ensure product quality, safety, and regulatory compliance. Our expertise spans a wide range of critical assays, including:
Glycan Profiling
Detailed characterization of glycosylation patterns to support comparability, stability, and release testing.
Charge Variant Analysis
High-resolution techniques such as icIEF and cation exchange to assess product heterogeneity
Aggregation Analysis
Size-exclusion chromatography (SEC) and light scattering methods to monitor product purity and stability.
Potency Assays
Custom-designed cell-based and binding assays to evaluate product functionality and bioactivity
GMP Manufacturing
Processes are developed with scalability and regulatory readiness in mind, ensuring a smooth path from early development to GMP manufacturing.
• Scalable platforms from benchtop to pilot and GMP scale
• Tech transfer documentation and QbD-based development
• Regulatory support and comparability assessments
Our work flow
How we work
Share Molecule & Objectives
Our experts design a tailored, end-to-end proposal covering development, manufacturing, and compliance requirements.
Propose Custom Development Plan
Our experts design a tailored, end-to-end proposal covering development, manufacturing, and compliance requirements.
R&D and process execution
We initiate lab work—cell line development, process optimization, and analytical testing—ensuring robust, reproducible results.
Comprehensive data & tech reports
You receive a full data package, regulatory-ready documentation, and expert guidance to move seamlessly to the next phase.
Transforming Research Into Real-World Impact
Leverage our proprietary CHO platforms and state-of-the-art automation to achieve high-yield, stable clones optimized for manufacturability and regulatory acceptance.
