SERVICES
Process Development
01
Upstream Process Development
02
Downstream Process Development
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Optimization of cell culture conditions, media, and bioreactor parameters.
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Development of high-yield, scalable, and reproducible processes for producing biologics, mRNA, and gene therapy products.
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Cell line development, media optimization, and scale-up from bench to pilot scale.
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Purification and recovery of the target product from the cell culture.
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Optimizing chromatography, filtration, and other purification steps to ensure high purity and yield of the final product.
03
Scale-Up and Tech Transfer
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Scaling up manufacturing processes from laboratory or pilot scale to full commercial scale.
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Technology transfer from the development site to manufacturing facilities, ensuring that the process remains consistent and reliable at larger scale
04
Process Characterization and Optimization
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Detailed process characterization and optimization studies to identify and control critical process parameters (CPPs) and critical quality attributes (CQAs).
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Using design of experiments (DOE) approaches to systematically assess and refine the manufacturing process, ensuring robustness, scalability, and reproducibility.
CMC Development
01
Process Development and Optimization
02
Analytical Method Development and Validation
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Optimization services, focusing on both upstream (e.g., cell culture, fermentation) and downstream (e.g., purification, formulation) processes.
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Yield improvement and cost reduction strategies.
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Development and validation of analytical methods for characterizing biologics, mRNA, and gene therapy products.
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Establishing methods for potency, purity, identity, and safety testing
03
Formulation Development
04
GMP Manufacturing of Clinical and Commercial Batches
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Identification and optimization of the most suitable formulations for biologics, mRNA, and gene therapy products.
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Development of stable, safe, and effective formulations that maintain product integrity
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Production of drug substance and drug product under strict GMP conditions
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Scaling up manufacturing processes for commercial production
Scale-Up & Process Validation
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Pilot-scale manufacturing services to bridge the gap between small-scale laboratory production and full-scale commercial manufacturing.
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Scaling up the production process to a pilot scale, allowing companies to produce larger batches for testing, stability studies, and early-stage clinical trials.
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Identification of any potential scale-up challenges before moving to commercial production.
Bio-Analytical Services
01
Mass Spectrometry and Chromatography-based Analysis
02
Impurity Identification and Biosimilarity Studies
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Peptide Mapping and Protein Identification
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Protein Quantification and Characterization
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Glycan Analysis
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Impurity Profiling and Trace Analysis
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Method Development and Validation
03
Biophysical Characterization
04
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Impurity Profiling
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Host Cell Protein (HCP) Analysis
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Biosimilarity Assessment
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Product-Related Variants Analysis
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Method Development and Validation
Stability Studies
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Assessment of structural and biophysical properties of biologic products and their aggregates.
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This includes techniques such as circular dichroism (CD), FTIR, and nuclear magnetic resonance (NMR) spectroscopy to elucidate protein folding, stability, and interactions.
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Protein aggregation studies, degradation studies, to observe the structural changes over time, to ensure product stability and integrity.
Regulatory Compliance & Quality Assurance
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FDA Query Response Management
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Regulatory Strategy Development
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Regulatory Submission Support
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Quality System Audits and Remediation
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Regulatory Training and Education
Preclinical and Clinical Services
01
DS/DP for Safety/Tox Studies
02
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GMP and Non-GMP Manufacturing of Drug Substance (DS)
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Analytical Method Development and Validation
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Supply Chain Management and Logistics for Preclinical Studies
03
Stability Studies for Preclinical Batches
04
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Stability studies on clinical-stage products to assess their shelf life, potency, and safety under various storage conditions.
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Long-term, accelerated, and stress testing, along with providing GMP-compliant storage solutions for clinical materials.
Clinical Stage Manufacturing
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GMP Manufacturing of Clinical Batches
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Scale-Up and Technology Transfer
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Aseptic Fill-Finish Services
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Stability Studies and Storage
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Regulatory Documentation and Support
Formulation Development for Preclinical Studies
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Formulation development services tailored to the needs of safety and toxicology studies.
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Creation of stable, bioavailable formulations that can be used in animal studies to assess the safety profile of the drug candidate.
Lead Optimization
01
Structure-Activity Relationship (SAR) Analysis
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in-depth Structure-Activity Relationship (SAR) analysis to refine and optimize lead compounds.
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systematically modification of chemical structures to enhance potency, selectivity, and overall therapeutic index while reducing potential off-target effects.
03
High-Throughput Screening (HTS)
02
In Silico Modeling and Predictive Analytics
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Computational modeling and predictive analytics services to simulate and predict the behavior of lead compounds in biological systems.
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Molecular docking studies, pharmacophore modeling, and predictive ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) analysis to identify and optimize the most promising candidates for further development.
04
PK and PD Optimization
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High-throughput screening (HTS) capabilities to rapidly test large libraries of lead compounds against specific biological targets.
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Development and validation of custom assays, allowing for the efficient identification of lead candidates with the desired biological activity.
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Optimization of pharmacokinetic (PK) and pharmacodynamic (PD) profiles of lead compounds to ensure they have suitable absorption, distribution, metabolism, and excretion properties.
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Optimizing dosing regimens, bioavailability, and half-life, as well as enhancing the therapeutic efficacy and safety profile of the candidates.
Cell and Gene Therapy Services
01
GMP Grade Viral Vectors Development
02
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Custom Viral Vector Design
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Viral Vector Production
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Process Development and Optimization
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Analytical Characterization
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Regulatory Support and Documentation
03
mRNA Production and Scale-Up
04
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GMP-grade mRNA for vaccines and therapeutics.
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Efficient, scalable synthesis processes.
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Purification and stability for clinical applications.
Gene Editing and Cell Line Engineering
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Custom Clone Generation
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Cell Line Stability Studies
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Cell Line Characterization
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Expression Optimization
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Regulatory Support and Documentation
pDNA Manufacturing
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GMP-grade plasmid DNA for gene therapy and vaccines.
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Scalable production processes.
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Purification and quality control for clinical use.
