Recombinant Protein & Enzyme CDMO Solutions
From Gene to GMP: Your End-to-End CDMO Partner for Accelerated Biologics Development.
Empowering Your Protein & Enzyme Programs
Recombinant proteins and enzymes are the cornerstones of modern therapeutics, diagnostics, and research. However, navigating the path from a promising gene sequence to a stable, scalable, and compliant commercial product is fraught with challenges. Low expression yields, complex purification, difficult scale-up, and stringent regulatory demands can stall even the most promising projects.
At Creative Biolabs, we provide comprehensive, end-to-end CDMO solutions designed to overcome these hurdles. We partner with you at every stage, from process development and optimization to cGMP manufacturing, ensuring your project milestones are met with speed, quality, and scientific excellence.
Core Capabilities & Applications
Serving diverse applications in therapeutics, diagnostics, and industrial biotechnology with specialized expertise in complex protein and enzyme production.
Recombinant Proteins
- Cytokines, growth factors, and fusion proteins
- Affinity-tagged research proteins
- Therapeutic candidates with developability assessments
- GMP manufacturing for clinical supply
Enzymes
- Industrial enzymes (lipase, amylase, protease)
- Diagnostic enzymes (polymerases, kinases)
- Biocatalysts for green chemistry & immobilization
- Thermostability & kinetics optimization
Key Application Areas
Our One-Stop CDMO Service Scope
We provide a fully integrated service portfolio covering the entire product lifecycle, from initial gene synthesis and process development to full-scale cGMP manufacturing and fill/finish.
Upstream Development & Process
- Gene Synthesis & Codon Optimization
- Expression Vector Construction
- Stable Cell Line / Strain Development
- Media & Feed Optimization (Fed-batch & Perfusion)
- Scalable Bioreactor Production (e.g., 50L, 200L, 2000L)
- High-Density Cell Banking (MCB/WCB)
- Process Parameter Screening & Optimization (DoE)
Downstream Purification & Analytics
- Harvesting, Lysis & Refolding
- Multi-step Chromatography Purification (Affinity, IEC, HIC)
- Tangential Flow Filtration (TFF) & Virus Clearance
- Analytical Method Development & Validation
- Full QC Panel (Purity, Identity, Potency, Safety)
- Impurity Profiling (HCP, HCDNA, Endotoxin)
- Characterization Studies (e.g., LC-MS, CD)
GMP Manufacturing & Fill/Finish
- Clinical (Phase I-III) & Commercial Supply
- Comprehensive QA/QC Oversight & Batch Records
- Formulation Development (Liquid/Lyophilized)
- Aseptic Filling, Finishing & Labeling
- Full cGMP Documentation Support for Regulatory Filings
- Process Validation (PPQ) & Scale-Down Models
- Long-Term Stability Storage & Testing
Key Expression Systems
Matching the right host system to your molecule's specific requirements, from high-yield microbial systems to complex mammalian expression for human-like PTMs.
Microbial (E. coli, Bacillus)
High yield & cost‑effective for non‑glycosylated proteins and many enzymes.
- Inclusion body refolding strategies
- Periplasmic & secretory expression
- Endotoxin control & clearance
Yeast (Pichia, S. cerevisiae)
Soluble expression with eukaryotic folding and optional glycosylation.
- AOX1/constitutive promoters
- Secretion signal engineering
- Glyco‑pattern management
Insect (Sf9, High Five)
Complex enzymes and multimeric proteins with correct folding.
- Baculovirus expression vectors (BEVS)
- Glycoforms distinct from mammalian
- Rapid scale-up for screening
Mammalian (CHO, HEK293)
Therapeutic‑grade proteins/enzymes with human‑like PTMs.
- Stable clone selection (GS/CHO, DHFR/CHO)
- Quality attributes: glycan, charge variants
- Perfusion for fragile products
End‑to‑End CDMO Workflow
A transparent, phase‑gated process to accelerate timelines and ensure tech transferability, guiding your project from concept to clinic seamlessly.
| Stage | Services | Key Technologies & Readouts |
|---|---|---|
| Gene & Vector Design | Codon Optimization, Gene Synthesis, Cloning | Promoter selection, signal peptides, secretion tags, sequence liabilities review |
| Cell Line / Strain Development | Stable/Transient Expression; E. coli, Pichia, Insect (Sf9/Hi5), CHO/HEK | Clone screening, productivity assays, glyco‑profiling (for mammalian) |
| Upstream Process Dev | Media optimization, fed‑batch/perfusion, scale‑down models | DoE, oxygen transfer, CPP/CQA mapping, PAT implementation |
| Downstream Purification | Capture/Intermediate/Polishing; tangential flow filtration | Affinity/IEC/HIC/SEC, impurity clearance, yield & purity balance |
| Analytical Development | Identity, Purity, Potency, Safety | HPLC/UPLC, LC‑MS/MS, CE‑SDS, endotoxin/bioburden, residual DNA/HCPI |
| Formulation & Stability | Buffer optimization, lyophilization feasibility, real‑time/accelerated stability | Tm, aggregation, viscosity, stress testing, container closure |
| GMP Manufacturing | Batch records, validation, release testing, QA oversight | Bioreactors up to 2,000 L, compliant documentation, lot consistency |
Committed to the Highest Quality Standards
Quality is not just a department; it's the foundation of our entire operation. Our robust Quality Management System (QMS) is woven into every stage of the project lifecycle. This system ensures that every project, from initial research-grade material to full-scale cGMP production, adheres to the strictest, phase-appropriate industry standards and regulatory expectations.
We operate state-of-the-art cGMP facilities designed to be fully compliant with global regulatory guidelines, including those from the FDA, EMA, and NMPA. Our dedicated Quality Assurance (QA) and Quality Control (QC) teams provide continuous, independent oversight throughout the entire manufacturing process. This vigilance guarantees the purity, safety, efficacy, and consistency of your product batch after batch. Furthermore, we provide comprehensive documentation support, preparing audit-ready data packages essential for your regulatory (IND, BLA, NDA) submissions.
cGMP COMPLIANT
ISO 9001 CERTIFIED
FDA / EMA / NMPA READY
IND/BLA/NDA SUPPORT
The Creative Biolabs Advantage
Discover why industry leaders and innovative startups consistently choose us as their trusted CDMO partner for their most critical programs.
Integrated End-to-End Solution
We manage your entire project lifecycle, from gene synthesis and vector construction to cGMP manufacturing and final fill/finish, providing a single, accountable partner.
Decades of Proven Expertise
With a track record of over 1,000 successful protein and enzyme projects, our scientific team possesses the deep expertise needed to overcome complex expression and purification challenges.
Speed and Project Flexibility
Our adaptable capacity planning and parallel processing workflows are designed to meet aggressive project timelines, accelerating your path to the clinic or market.
Transparent Project Management
You will be assigned a dedicated PhD-level Project Manager who provides clear, proactive communication, regular progress reports, and ensures your project stays on track.
Robust, Phase-Appropriate Quality
Our philosophy is "right-first-time." We maintain a stringent, cGMP-compliant Quality Management System that scales with your project from R&D to commercial production.
Seamless Scalability
We ensure seamless technology transfer from bench-scale process development to 2,000L+ cGMP production, utilizing scale-down models to ensure consistency and success.
What Our Partners Say
Read real-world feedback from biotech and diagnostic leaders who trust us with their projects.
★★★★★
"Creative Biolabs successfully scaled our complex enzyme from 10L to 500L cGMP. Their process development team solved a critical solubility issue, and the documentation package for our IND filing was flawless."
★★★★★
"We needed high-purity recombinant protein for our diagnostic assay. The team delivered 500mg ahead of schedule with >99% purity by HPLC. Their analytical team is truly top-notch."
★★★★★
"Switching to Creative Biolabs was the best decision we made. Their project management is transparent, and they provided weekly updates. They optimized our E. coli expression and increased our yield 5-fold."
Frequently Asked Questions
Find quick answers to common inquiries about our CDMO services, processes, and technical capabilities.
What CDMO services do you offer for recombinant proteins and enzymes?
We provide a comprehensive, one-stop solution. This begins with gene synthesis and codon optimization, moving to expression vector construction and stable cell line or strain development. We then cover full upstream (media/feed optimization, bioreactor scale-up) and downstream (purification, TFF, analytics) process development. Finally, we manage cGMP manufacturing for clinical or commercial supply, including formulation, aseptic fill/finish, and full regulatory documentation support.
Which expression system is right for my molecule?
The best system depends on your molecule's characteristics and goals. For simpler, non-glycosylated proteins where speed and cost are key, *E. coli* is excellent. For proteins requiring basic eukaryotic folding or secretion, *Pichia* yeast is a powerful, high-yield choice. For complex enzymes or proteins needing post-translational modifications (PTMs) closer to, but not identical to, human, our insect (BEVS) platform is ideal. For therapeutic proteins requiring human-like PTMs (e.g., glycosylation), our mammalian (CHO, HEK293) systems are the cGMP standard.
How do you ensure regulatory compliance?
Compliance is central to our operation. Our Quality Management System (QMS) is built to be cGMP compliant and aligns with global regulatory guidelines (ICH, FDA, EMA). We ensure this through rigorous, independent QA oversight, comprehensive validation of processes and analytical methods, strict data integrity controls, and meticulous documentation (e.g., Master Batch Records, CoAs, full traceability). Our facilities are audit-ready for both clients and regulatory agencies.
How do you handle tech transfer if I have an existing process?
We have a dedicated, phased tech transfer process. It begins with a gap analysis of your existing data package (cell line, process descriptions, analytical methods). Our team then works with yours to transfer materials and methods, performing initial verification runs. We optimize as needed (e.g., for new raw materials or scale) and perform engineering runs before proceeding to full cGMP validation. Clear communication and a joint project team are key to ensuring the transfer is seamless and successful.
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