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CD Biosynsis engineers microbial platforms for pharmaceutical development. From API synthesis to therapeutic protein expression, we deliver production systems validated for regulatory submission and clinical trial material production.
Serving the Pharmaceuticals & Therapeutics Ecosystem
Pharma Companies
API and drug substance manufacturers
Biotech Companies
Novel therapeutic developers
Vaccine Manufacturers
Biological vaccine producers
Generic Drug Makers
Cost-optimized production platforms
End-to-end infrastructure for pharmaceutical biotechnology development
Active pharmaceutical ingredient production
Antibodies, enzymes, and cytokines
Antigen and VLP production platforms
Novel chemical entity biosynthesis
Pharmaceutical development demands cost-effective, scalable production of complex molecules. Our platform addresses these challenges through precision-engineered microbial cell factories.
Many pharmaceutical APIs have intricate structures impractical via chemical synthesis. Microbial fermentation enables complex natural product production that chemical routes cannot match.
Biologic therapeutics remain expensive due to production costs. Engineered cell factories reduce COGS through yield optimization and process intensification for broader patient access.
Active pharmaceutical ingredients increasingly sourced from limited regions. Domestic microbial production ensures supply reliability and reduces geopolitical risk for critical medicines.
Platform Approach
40% faster development
We provide specialized microbial engineering for pharmaceutical production. From chassis strain development to GMP process validation, our team delivers systems ready for regulatory submission and clinical trial material supply.
Design and optimize microbial pathways for pharmaceutical compounds including natural products, antibiotic intermediates, and novel therapeutics.
Develop optimized expression systems for antibodies, enzymes, and cytokines achieving high titer and quality for clinical development.
Engineer antibodies for enhanced affinity, stability, and manufacturing. Create bispecific constructs and ADCs with optimized linker chemistry.
Establish in vitro transcription systems for mRNA therapeutics with optimized UTR design, nucleoside modifications, and LNP formulation compatibility.
Discover and engineer novel antibiotics and anticancer agents through genome mining and heterologous expression of microbial secondary metabolites.
Produce vaccine antigens including viral proteins, bacterial subunits, and VLPs with stable cell lines or optimized fermentation processes.
Why the pharmaceutical industry is transitioning to biological solutions
| Parameter | Chemical Inputs | Synthetic Biology |
|---|---|---|
| Synthesis Complexity | Often requires 10-30+ chemical steps | Biological synthesis in single cell |
| Stereochemistry Control | Expensive chiral catalysts often required | Inherent stereoselectivity of enzymes |
| Production Scale | Batch chemical processing | Scalable fermentation technology |
| Environmental Impact | Hazardous solvents and reagents | Aqueous, mild conditions |
| Supply Chain | Complex global sourcing | Domestic fermentation capability |
GMP-compliant capabilities for pharmaceutical biotechnology from discovery through clinical trials.
CRISPR, gene synthesis, and pathway engineering for pharmaceutical compounds
ICH-compliant methods for pharmaceutical characterization
GMP process development and validation
FDA, EMA, and international pharmaceutical regulatory submissions
We function as your external strain engineering and metabolic pathway team. Whether you need a single engineered chassis or a complete pathway optimization pipeline, we deliver publication-quality data and transfer-ready strains.
Each project is assigned a dedicated PhD-level scientist as primary contact, ensuring technical continuity and rapid decision-making throughout development.
Engage us for full end-to-end development or specific phases (strain engineering only, fermentation optimization only, etc.). Scale investment according to your validation needs.
All proprietary strains and sequences remain your exclusive property. We offer clean IP transfer with no residual license claims or downstream revenue sharing requirements.
In-house regulatory affairs team experienced with FDA IND/NDA, EMA, and ICH Q7 guidelines. We prepare submission-ready dossiers for your target markets.
Concept to pilot validation. Includes strain engineering, fermentation optimization, and greenhouse testing.
Genetic modification and characterization. Deliverables include sequence-confirmed strains and technical reports.
Process development and optimization. From lab-scale proof to pilot-scale production parameters.
Characterization, stability testing, and regulatory dossier preparation for submission.
Get answers to common questions about our pharmaceutical solutions. our team for project-specific inquiries.
We offer GMP-compliant process development and pilot-scale production (up to 1000L). For commercial GMP manufacturing, we facilitate technology transfer to qualified CDMOs or support client facility qualification per ICH Q7 guidelines.
Our regulatory team has experience with FDA (IND, BLA, NDA), EMA (MAA), and international submissions. We prepare comprehensive CMC documentation including cell line characterization and analytical method qualification.
Yes, we maintain DEA-licensed facilities for Schedule I-V controlled substances research with appropriate compliance documentation for pharmaceutical development.
We have successfully heterologously expressed over 50 complex natural product biosynthetic gene clusters including polyketides, nonribosomal peptides, terpenoids, and hybrid pathways with rapid expression and optimization.
Regulatory classification depends on your final product and modification approach. We can engineer strains using methods that may qualify for streamlined review (e.g., self-cloning, site-directed mutagenesis). Our regulatory team provides guidance on FDA IND/NDA/BLA Pathways, EMA Marketing Authorization, and ICH Q7 (GMP for APIs) requirements. We support CMC (Chemistry, Manufacturing, and Controls) documentation and pharmacopoeia compliance (USP/EP) for quality control data and preclinical CMC filings. during the project design phase to ensure your strain aligns with your intended regulatory pathway.
Get a customized quote for your Pharmaceuticals and Therapeutics project. Our experts will respond within 24 hours.
CD Biosynsis is a leading customer-focused biotechnology company dedicated to providing high-quality products, comprehensive service packages, and tailored solutions to support and facilitate the applications of synthetic biology in a wide range of areas.