Integrated cGMP Cell Line Development for Biologics CDMO
Accelerate Your Path to IND and Market: Stable, High-Titer, and Scalable Cell Line Development, Seamlessly Integrated with Process Development and cGMP Manufacturing.
The Foundation of Successful Biomanufacturing Starts Here
Cell line development (CLD) is unequivocally one of the most critical steps in the biopharmaceutical manufacturing journey. The selection of a robust, high-producing, and stable cell line is the bedrock that determines the success of all subsequent process development (PD), directly impacts the cost of goods (COGs), and ultimately dictates the speed to market for a novel biologic.
Navigating the CLD pathway presents significant challenges, from ensuring true monoclonality and genetic stability to achieving commercially viable titers while maintaining critical product quality attributes (CQAs). A suboptimal clone selected early on can lead to costly failures, delays in clinical timelines, and insurmountable manufacturing hurdles down the line.
At Creative Biolabs, we understand this critical link. As a premier CDMO partner, we deliver more than just a cell line; we provide a fully characterized, regulatory-compliant, and production-ready manufacturing solution. Our process is engineered from day one with scalability, stability, and product quality in mind, ensuring a seamless transition from DNA to cGMP Master Cell Bank and into your clinical manufacturing campaign.
Developing Cell Lines for Diverse Biologics
Our cell line development services are pivotal in diverse molecule applications, including:
Monoclonal Antibody Production
Developing stable cell lines for high-yield production of therapeutic mAbs.
- Optimized for industry-standard mAbs, biosimilars, and novel antibody constructs.
- Focus on high productivity (e.g., >5-10 g/L) to reduce future COGs.
- Ensures robust clonal stability and consistent product quality attributes.
Bispecific and Tri-specific Antibodies
Tailoring cell lines for the expression of complex antibody formats that require specific post-translational modifications.
- Expertise in complex vector design and co-transfection strategies.
- Proprietary platforms to ensure correct chain pairing and assembly.
- Screening for high expression, stability, and desired biological function.
Antibody-Drug Conjugates (ADCs)
Generating cell lines capable of producing antibodies conjugated to cytotoxic drugs for targeted cancer therapy.
- Development of mAb cell lines suitable for subsequent conjugation (e.g., site-specific).
- Ensures high antibody purity and minimal aggregation pre-conjugation.
- Seamless integration with our downstream conjugation and purification (DSP) services.
Recombinant Proteins and Enzymes
Facilitating the production of various recombinant proteins and enzymes used in therapeutics and diagnostics.
- Handling diverse protein types, including fusion proteins, enzymes, and cytokines.
- Expertise in managing difficult-to-express or complexly folded proteins.
- Tailored platform selection (CHO, HEK293) to achieve required post-translational modifications.
Biosimilars
Accelerate your biosimilar pipeline by developing highly productive, stable cell lines designed to be analytically indistinguishable from the reference product.
- Rigorous clone selection based on matching Critical Quality Attributes (CQAs) to the reference product.
- Comprehensive stability studies to ensure long-term manufacturing consistency and viability.
- Generation of a full data package to support comparative analytics and regulatory submissions.
Comprehensive Service Scope
From DNA to cGMP Master Cell Bank, we offer a fully integrated service portfolio tailored to your phase of development.
Non-cGMP Development (For Research & Toxicology)
- Ideal for research, proof-of-concept, and non-clinical tox studies.
- Rapid generation of stable pools for early material supply.
- Mini-pool screening to identify high-potential candidates.
- Generation of Research Cell Banks (RCB) for your internal use and process development.
Full cGMP Development (For Clinical & Commercial)
- Our flagship offering designed for IND/BLA submissions.
- Full traceability and cGMP-compliant documentation from start to finish.
- Includes comprehensive clonality, stability, and characterization.
- Culminates in a fully released cGMP Working Cell Bank (WCB) ready for manufacturing.
High-Throughput Screening & Selection
- State-of-the-art single-cell cloning (FACS, Limiting Dilution).
- Screening of thousands of clones for productivity and growth.
- Fed-batch screening in miniaturized bioreactors (e.g., Ambr®) to predict large-scale performance.
- Early-stage product quality (CQA) assessment to select the best candidates.
Our Phased CLD Workflow
A transparent, phase-gated process designed for speed, quality, and regulatory compliance.
| Stage | Key Activities | Key Deliverables & Milestones |
|---|---|---|
| Phase 1: Construct & Transfect | Gene synthesis, codon optimization, cloning into proprietary expression vector, preparation of transfection-grade DNA, high-efficiency transfection of host cells. | Verified high-expression plasmid, high-productivity stable pool generation. |
| Phase 2: Clonal Selection | Single-cell cloning via validated methods (FACS, or Limiting Dilution), high-throughput screening of 96-well plates for productivity. | Identification and expansion of ~20-30 top-producing clones. |
| Phase 3: Clone Characterization | Fed-batch screening of top clones in miniaturized bioreactors (e.g., Ambr®), comprehensive 60+ generation stability study (growth & productivity). | Selection of top 1-3 lead candidates, stability data, preliminary CQA data. |
| Phase 4: Cell Banking | Generation of a Research Cell Bank (RCB) for process development. Manufacturing of the cGMP Master Cell Bank (MCB) and cGMP Working Cell Bank (WCB) in a qualified cGMP suite. | ~20-vial RCB, ~50-vial cGMP MCB, ~200-vial cGMP WCB, full Certificate of Analysis (CoA). |
| Phase 5: Documentation | Authoring of comprehensive CLD report, compilation of all analytical data, generation of full clonality report, and cGMP batch records. | Complete, IND/BLA-ready documentation package. |
Deliverables: Your Complete CLD Package
We provide a comprehensive, fully characterized package ready for process development and regulatory submission.
cGMP Master Cell Bank (MCB)
~50 VialsManufactured under strict cGMP conditions in our qualified suite. Fully characterized for identity, purity, and safety.
cGMP Working Cell Bank (WCB)
~200 VialsDerived from the MCB, this bank is used for all cGMP manufacturing campaigns. Characterized per ICH guidelines.
Comprehensive CLD Report
IND/BLA ReadyA full, submission-ready report detailing the entire development history, including vector construction, clonality, and all characterization data.
Complete Characterization & Documentation
Identity & Clonality
- Proof of Clonality Report (FACS/Imaging)
- Vector Sequence Verification
- Genetic Identity (e.g., STR Analysis)
Purity & Safety
- Sterility (USP/EP)
- Mycoplasma (qPCR & Culture)
- Adventitious Virus Testing (In Vivo / In Vitro)
- Retrovirus Testing
Stability
- Generation Stability (>60 Generations)
- Productivity Stability Over Time
- Post-Thaw Viability and Growth
- Product Quality (CQA) Stability
Full Rights
- Full, Royalty-Free Commercial Rights
- Complete Certificate of Analysis (CoA)
- All Supporting Batch Records
- Full Data Package
Featured Service Package
Tailored services to meet your specific cell line development and characterization needs.
Host Cell Commercial Licensing Service
We provide commercial licensing for high-performance host cell lines, which are optimized for high yield and stability, ensuring efficient production processes.
Mammalian Cell Line Development Service
Our mammalian cell line development service includes gene synthesis, vector construction, transfection, and clone screening. We utilize advanced technologies like automated high-throughput screening to identify top-performing cell lines.
Cell Line Passage Stability Evaluation Service
To ensure the long-term stability of cell lines, we conduct rigorous passage stability evaluations. This includes assessing the genetic stability and consistency of protein expression over multiple generations.
Cell Bank Storage Stability Evaluation Service
We offer comprehensive cell bank storage and stability evaluation services. This includes the establishment of master and working cell banks, as well as long-term storage solutions compliant with regulatory standards.
Antibody Production Cell Line Development Service
Our antibody production cell line development service is designed to generate high-yielding cell lines for monoclonal antibody production. We focus on optimizing both upstream and downstream processes to maximize productivity and product quality.
ADCC Enhanced Cell Line Development Service
Creative Biolabs offers ADCC enhanced cell line development services. This involves engineering cell lines to produce antibodies with improved ADCC activity, which is crucial for the efficacy of certain therapeutic antibodies.
Cell Bank Establishment, Testing, and Characterization Service
We provide full-service cell bank establishment, including thorough testing and characterization. This ensures that the cell banks meet all regulatory requirements and are ready for clinical and commercial use.
Beyond Cell Lines: Your Complete CDMO Partner
Cell Line Development is the first step. Our partnership extends from gene to drug product, all under one Quality Management System.
Upstream Process Development
Seamless tech transfer of your new cell line into our scalable USP platform for media/feed optimization and scale-up.
- Fed-batch and perfusion strategies
- Process characterization (DoE)
- Scale-down model validation
Downstream Process Development
Platform-based or custom purification process development designed for high yield and purity.
- Chromatography & filtration optimization
- Impurity clearance studies
- Viral clearance validation
Analytical & Formulation
Full analytical method development, validation, and stability-indicating formulation development.
- CQA-driven method development
- Full ICH stability programs
- Reference standard characterization
cGMP Mfg. & Fill-Finish
Scale-up and cGMP manufacturing of your drug substance, followed by aseptic fill-finish and release.
- Clinical and commercial supply
- Aseptic vialing and labeling
- Full batch release & Qualified Person (QP) release
Facilities & Quality Systems
Our cell banking activities are performed in dedicated, cGMP-compliant suites with unidirectional flows and rigorous environmental monitoring to ensure the aseptic integrity of your cell banks. Our Quality Management System (QMS) is rigorously aligned with global cGMP standards, including ICH Q5D (Cell Substrates), Q5B (Genetic Stability), and Q5A (Viral Safety). This framework governs all operations, including our robust deviation/CAPA processes, stringent change control, comprehensive data integrity (ALCOA+) policies, and full equipment (IQ/OQ/PQ) and method validation.
We provide complete, audit-ready documentation packages, including all batch records, validation reports, and raw material specifications. Our dedicated QA team actively supports client audits and provides transparent, expert support for all regulatory interactions and submissions related to your cell line.
cGMP COMPLIANT
ICH Q5D COMPLIANT
FDA / EMA READY
IND/IMPD SUPPORT
What Our Partners Say
Real feedback from our cell line development partners.
★★★★★
“Creative Biolabs was remarkable. They took our difficult-to-express fusion protein and delivered a 6 g/L clone in 14 weeks. Their Ambr® screening data was highly predictive of the 200L run, which saved us months of rework. A truly integrated CDMO partner.”
★★★★★
“The speed from transfection to a fully characterized RCB was incredible. But the real value was the documentation package for our IND submission. The clonality report was thorough, data-driven, and sailed through regulatory review without a single question.”
★★★★★
“We transferred in our existing, low-producing cell line. The Creative Biolabs team re-developed it using their vector and host platform, resulting in a 4-fold increase in titer and significantly better CQA profiles. Their expertise is top-tier.”
Frequently Asked Questions
Quick answers to common questions about our CLD services.
What are your typical Cell Line Development (CLD) timelines?
We pride ourselves on efficiency. Our cell line development process typically spans four months from gene synthesis to the creation of a stable Research Cell Bank (RCB), although exact timelines depend on specific project requirements.
How do you ensure and document clonality?
We ensure monoclonality using state-of-the-art, validated methods such as single-cell sorting via FACS or automated colony picking with high-resolution imaging. We provide a comprehensive, submission-ready clonality report that includes imaging data and process details, fully satisfying FDA and EMA requirements.
What titers can you guarantee for my molecule?
While final titers are molecule-specific, our CHO platform is highly optimized and consistently achieves titers in the 5-10 g/L range for standard mAbs. For biosimilars or well-characterized molecules, we often exceed these benchmarks. Our primary focus is on selecting a clone with the best combination of high productivity, genetic stability, and critical product quality attributes (CQAs) to ensure a robust and scalable manufacturing process.
Do I get full rights to the final cell line?
Our CDMO service agreement covers the complete development of the cell line and the delivery of cell banks (e.g., Research Cell Bank) for your research and development purposes. The rights for subsequent clinical and commercial manufacturing are established under a separate licensing agreement. We offer flexible licensing models, ranging from milestone-based options to full buyouts, which are negotiated independently of the service contract to best suit your long-term goals.
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