Bridging the Gap from Laboratory Bench to Commercial Biologics
Specialized technology transfer, upstream & downstream process development, and scale-up engineering for recombinant proteins, peptides, and monoclonal antibodies.
Integrated Bioprocess Capabilities
End-to-end development services engineered to accelerate therapeutic molecules from early construct stage into regulatory compliance and commercial manufacture.
High-Recovery Downstream Purification Trains
Multi-modal chromatography skids, ultrafiltration/diafiltration (UF/DF) systems, and validated viral clearance filtration.
Technology Transfer
Seamless handoff from R&D to GMP manufacturing — including full documentation and regulatory support.
- — End-to-end R&D to GMP transfer
- — Process standardization & reproducibility
- — Regulatory filing documentation
Process Development
Upstream and downstream optimization to maximize yield, purity, and consistency at every scale.
- — Fermentation & cell culture development
- — Purification and yield enhancement
- — Upstream & downstream optimization
Scale-Up & Commercialization
Pilot-to-commercial transitions that protect process integrity and accelerate market entry.
- — Pilot to commercial scale transition
- — Techno-commercial feasibility studies
- — Manufacturing readiness assessment
Featured Molecules & Therapeutics
High-growth recombinant proteins, peptides, and monoclonal antibodies with ready-to-transfer CMC packages.
High-Affinity Peptides & Recombinant Antibodies
Comprehensive physicochemical profiling, intact mass spectrometry (LC-MS), and conformational stability validation under ICH Q2(R1) guidelines.
Semaglutide
A long-acting GLP-1 receptor agonist used in Type 2 Diabetes and obesity management — one of the fastest-growing therapeutic segments globally.
- Clone development & high-density fermentation
- Upstream & downstream purification process
- Chemical synthesis conjugation & fatty acid chain attachment
- Analytical method validation & ICH characterization package
Human Growth Hormone (Somatropin)
A recombinant human growth hormone used widely in endocrinology and pediatric/adult metabolic disorders, with strong and sustained global demand.
- Clone development & high-titer fermentation
- Inclusion body isolation, solubilization & refolding optimization
- Multi-step chromatography & final bulk preparation
- Formulation stability & commercial scale-up support
Pembrolizumab
A humanized IgG4 monoclonal antibody targeting PD-1 (Programmed Cell Death Protein 1), with landmark approvals across immuno-oncology for multiple solid tumors.
- High-producing CHO cell line development & feed optimization
- Protein A affinity capture, viral inactivation & polishing chromatography
- Full biosimilarity physicochemical & functional characterization
- Regulatory CMC dossier preparation & single-use bioreactor scale-up
Brazzein
A naturally occurring 54-amino-acid sweet protein isolated from the West African plant Pentadiplandra brazzeana. Up to 2,000× sweeter than sucrose with zero calories, exceptional heat and pH stability, and no glycemic effect.
- E. coli recombinant expression (soluble, disulfide-intact structure)
- Proof-of-Concept completed at 8L fermentation scale
- Single-step chromatography purification with high recovery
- ENK enzyme digestion & HPLC analytical method validated
- LC-MS intact mass characterization; target yield >1.8 g/L
- GRAS regulatory safety strategy & scale-up roadmap
Key Value Differentiators
Designed from the ground up to solve complex bioprocess bottlenecks with uncompromising quality standards.
Specialized in Biologics Technology Transfer
Our entire practice is built around the challenges of complex biologics — not a side offering within a larger organization.
Expertise Across Microbial & Mammalian Platforms
We operate across both fermentation-based and mammalian cell culture systems, giving clients broader molecule coverage.
Focus on Scalability & GMP Readiness
Every process we develop is designed with commercial-scale and regulatory compliance in mind from day one.
Integrated Support: Clone → Process → Scale → Commercial
A single partner for the full development journey — reducing handoff risk and keeping timelines on track.
Ideal Partner for Biosimilars, CDMOs & Biotech Startups
Whether you're developing a biosimilar or building a new biologics program, we adapt to your stage and scale.
Partner with Kovi for Seamless Tech Transfer
Connect with our technical leadership team to discuss process optimization, yield projection dossiers, and facility fit assessments.