CDMO Solutions for Antibody & Biologics Development
From Gene to GMP — Accelerating Your Biotherapeutic Journey with Proven Expertise and Flexible Manufacturing Capabilities.
Your End-to-End Partner in Biologics Development & Manufacturing
For over 15 years, Creative Biolabs has been a trusted partner to the global biopharmaceutical industry. We bridge the critical gap between discovery and commercialization with truly end-to-end CDMO solutions tailored for antibody therapeutics, complex biologics, and advanced gene therapy vectors.
Leveraging state-of-the-art facilities, advanced bioprocessing technologies, and expert-driven project management, we specialize in high-quality antibody CDMO services and cGMP plasmid DNA manufacturing. Our integrated platform is designed to support clients from early-stage research and IND filing through to robust, scalable cGMP production and commercial supply. We empower you to accelerate timelines, mitigate risk, and bring life-changing therapies to patients faster.
A Fully Integrated Service Platform
We provide a comprehensive, one-stop-shop solution covering every stage of your product's lifecycle, from the initial vector design to the final aseptic fill.
Cell Line & Vector Development
Building the foundation of your biologic with speed, stability, and high-titer expression. Key services include: Stable Cell Line Generation (CHO, HEK293), Plasmid DNA Construction & Optimization, and cGMP Cell Banking (MCB/WCB).
Process Development (PD)
Designing efficient, reproducible, and scalable processes ready for cGMP transfer. Our expertise covers USP/DSP Development, ICH-compliant Analytical Method Development, and seamless Process Scale-Up.
Non-GMP/GMP Manufacturing
Reliable and scalable manufacturing of your drug substance in our state-of-the-art facilities. We offer flexible-scale (1L-2000L) production for both non-GMP and cGMP modalities with full regulatory-ready CMC documentation.
Fill-Finish & Quality Control
Ensuring the purity, potency, and safety of your final drug product. We provide aseptic filling for liquid/lyophilized forms and comprehensive QC testing for lot release and stability studies.
Regulatory Support
We provide comprehensive guidance on navigating global regulatory requirements, assisting with submissions, strategy, and compliance across FDA, EMA, and ICH standards to minimize delays.
Supply Chain System
Our end-to-end supply chain management services ensure your products are delivered on time, optimizing logistics, tracking, and inventory management for a smooth and reliable product flow.
Deep Expertise Across Diverse Biologic Modalities
We integrate cross-platform expertise to accelerate your biologics pipeline, from standard monoclonal antibodies to advanced gene and cell therapy vectors.
Monoclonal & Bispecific Antibodies
Our platform excels in the rapid development and cGMP manufacturing of diverse antibody formats. We address complex challenges such as stability, aggregation, and productivity, ensuring a robust pipeline from discovery to clinical supply.
- High-titer transient and stable CHO cell line development.
- Expertise in complex formats: Bispecifics (BsAbs), scFv, Fab, and VHH.
- Comprehensive analytical and characterization services (e.g., purity, binding, stability).
Recombinant Proteins & Enzymes
We provide scalable production of high-purity recombinant proteins and enzymes for therapeutic and diagnostic use. Our expertise spans multiple expression systems to optimize for yield, folding, and post-translational modifications.
- Flexible expression systems: CHO, HEK293, E. coli, Pichia pastoris.
- Optimized upstream (USP) and downstream (DSP) process development.
- Purification strategies designed to achieve therapeutic-grade purity and activity.
Plasmid DNA & mRNA Vectors
As a leader in pDNA manufacturing, we supply high-quality plasmid DNA at all scales, from R&D to cGMP grade. Our services are foundational for advanced gene therapies, mRNA vaccines, and viral vector production.
- High-yield fermentation processes (up to 1000L) with optimized E. coli strains.
- Dedicated cGMP suites and purification trains for gene therapy applications.
- Stringent QC for purity, high supercoiled content, and low endotoxin levels.
Viral Vectors
We offer end-to-end CDMO services for key viral vectors, supporting gene therapy programs from process development to cGMP manufacturing. Our platforms are designed for scalability and regulatory compliance.
- Established platforms for AAV (multiple serotypes), Lentivirus, and Adenovirus.
- Scalable suspension culture systems using HEK293 and Sf9 cells.
- Comprehensive analytics: titration (qPCR/ddPCR), empty/full capsid ratio, and purity.
Antibody-Drug Conjugates (ADC)
Our integrated ADC services combine our expertise in cGMP antibody manufacturing with advanced conjugation chemistry. We provide a seamless "one-stop-shop" solution from antibody production to the final fill/finish of the ADC drug product.
- Expertise in both site-specific and stochastic conjugation technologies.
- Full CMC support for linker, payload, and the conjugation process.
- Advanced analytical development for Drug-to-Antibody Ratio (DAR), drug load, and purity.
B Cell/T Cell Receptors (BCR/TCR)
We specialize in the complex development of engineered cell-based immunotherapies and receptor therapeutics. Our expertise covers soluble TCRs for oncology and engineered B cell therapeutics, navigating the unique challenges of these novel modalities.
- Soluble T Cell Receptor (sTCR) and B Cell Receptor (BCR) expression.
- Mastery of complex protein folding and refolding challenges.
- Support for both autologous and allogeneic cell therapy workflows.
Specialized Platform Solutions
Targeted CDMO services for your specific modality, from plasmid DNA manufacturing to complex antibody engineering.
Plasmid CDMO Solutions
We provide high-quality, scalable plasmid DNA manufacturing for gene therapy, mRNA vaccines, and viral vector production, from R&D to cGMP grade.
-
Strains & Strain Bank Establishment
Development and validation of high-yield microbial strains, followed by comprehensive MCB/WCB cGMP cell banking. -
Plasmid Production Process Development
Optimized high-cell-density fermentation (up to 1000L) and robust purification processes to ensure high supercoiled content. -
Plasmid Quality Studies
Comprehensive analysis including purity, supercoil content, endotoxin levels, and residual host-cell DNA/RNA.
Antibody CDMO Solutions
Our end-to-end antibody services accelerate your therapeutic from discovery to IND, handling even the most complex formats with precision and speed.
-
Recombinant Antibody Production & Engineering
Expertise in humanization, affinity maturation, and engineering complex formats like bispecifics and scFv. -
Cell Line Development
Generation of high-titer, stable CHO/HEK293 cell lines with full traceability and regulatory-ready documentation. -
Antibody Production Process Development
Scalable upstream and downstream process development to optimize yield, purity, and manufacturability. -
Antibody Quality Studies
Comprehensive analytical characterization, including stability, purity (HPLC, CE-SDS), and binding (SPR, ELISA) assays.
Powered by Proprietary Technology
Our services are enhanced by a suite of battle-tested technology platforms designed to maximize efficiency, titer, and purity.
Hi-Affi™ Antibody Engineering Platform
Our advanced platform for antibody humanization, affinity maturation, and complex engineering (e.g., bispecifics), ensuring optimal binding and reduced immunogenicity. We utilize in silico modeling and high-throughput screening to deliver antibodies with superior therapeutic profiles.
Hi-Titer™ Expression Optimization System
A proprietary, robust system combining vector optimization, media screening, and cell line development to achieve industry-leading titers in both CHO and HEK293 expression systems. This accelerates timelines and reduces the cost of goods for cGMP manufacturing.
Hi-Pure™ Downstream Purification Suite
A comprehensive suite of scalable, multi-step purification protocols designed to achieve the highest levels of purity, homogeneity, and endotoxin removal for your drug substance. Our platform is optimized for various modalities, ensuring product safety and quality.
Hi-Form™ Formulation Optimization
Expert-driven formulation development services that assess multiple excipients, buffers, and conditions to identify the optimal stable, high-concentration formulation for your biologic. We provide robust data packages to support long-term stability and shelf-life.
State-of-the-Art Equipment & Facilities
Our world-class infrastructure integrates advanced upstream and downstream technologies to deliver scalability, consistency, and global regulatory compliance across every CDMO program.
Single-Use Bioreactor Systems (1–2000 L)
Flexible stirred-tank & wave bioreactors for CHO/HEK293 and microbial processes, enabling seamless scale-up from R&D to GMP.
Chromatography Platforms
ÄKTA™ systems and continuous chromatography for high-purity capture/polish steps (Protein A, IEX, HIC, SEC) with validated methods.
Filtration & Tangential Flow (TFF)
Scalable UF/DF and depth filtration trains for efficient concentration and buffer exchange with robust process analytics.
Aseptic Fill-Finish Suites
ISO Class 5/7 core areas with automated vial/syringe filling, lyophilization, in-line check-weighing and visual inspection systems.
Analytical Instrumentation
HPLC/UPLC, LC-MS, CE-SDS, icIEF, DLS, ELISA and platform bioassays supporting in-process control, release, and stability testing.
GMP Cleanrooms & EBR
Validated ISO Class 7/8 suites with environmental monitoring, data integrity controls, and electronic batch records (EBR).
The Creative Biolabs Advantage
We are more than a service provider; we are an extension of your team, dedicated to your project's success.
Proven Scientific Expertise
Leverage over 15 years of deep scientific knowledge. We are scientists first, helping you solve complex technical challenges.
Flexible & Scalable Manufacturing
Our facilities offer scales from R&D to 2000L GMP, providing the flexibility you need as your project advances.
Uncompromising Regulatory Compliance
Navigate the regulatory landscape with confidence. We provide robust, FDA/EMA-aligned documentation for seamless IND/BLA filings.
Integrated CRO + CDMO Workflow
Benefit from a single, continuous workflow. Our seamless transition from discovery to manufacturing saves time and reduces tech transfer risk.
Absolute IP Security & Confidentiality
We operate under strict confidentiality agreements and secure data management policies to ensure the protection of your IP.
Global Client Success & Reliability
Join over 200+ global pharma and biotech partners who trust us to deliver their projects on time and to specification.
Certified Quality: ISO 9001:2015 Registered
Demonstrating our robust commitment to quality, customer satisfaction, and continual improvement through internationally recognized standards.
Creative Biolabs is proud to be an ISO 9001:2015 certified organization. This certification is a testament to our rigorous Quality Management System (QMS), which underpins every aspect of our CDMO services.
What This Means for You:
- Consistent Quality: Our processes are standardized and audited to ensure reliable, high-quality outcomes for every project.
- Customer Focus: We are committed to meeting and exceeding your expectations, with clear communication and feedback loops.
- Risk Management: Proactive identification and mitigation of risks throughout the project lifecycle.
- Continuous Improvement: Our commitment to the ISO 9001 standard drives us to continually refine our processes, technologies, and services.
Trusted By Leading Innovators
.svg)
Frequently Asked Questions
What can you produce under cGMP conditions?
Our cGMP-compliant facilities are equipped for a wide range of biologics. This includes, but is not limited to, cGMP manufacturing of monoclonal antibodies (mAbs), complex bispecific and multispecific antibodies, recombinant proteins, and therapeutic enzymes. We have a particular specialization in producing high-quality, high-supercoil plasmid DNA for gene therapy and mRNA vaccine applications, and also provide end-to-end support for viral vector (AAV, Lentivirus) and Antibody-Drug Conjugate (ADC) programs.
How do you ensure quality and compliance?
Quality is the foundation of our operations. We maintain a robust, cGMP-compliant Quality Management System (QMS) that is fully aligned with FDA, EMA, and ICH guidelines and certified by ISO 9001:2015. This system governs every process, from raw material sourcing and facility monitoring to data integrity and final batch release. Our independent Quality Assurance (QA) team is integrated into every project, conducting rigorous audits, process oversight, and documentation review to ensure your product meets all specifications and regulatory requirements.
Can you handle technology transfer?
Yes, we excel at technology transfer, whether it's an early-stage process from your lab or a mature process from another CDMO. Our dedicated tech transfer team, composed of project managers and technical experts, creates a detailed, phase-gated plan. We work collaboratively to identify potential risks, adapt processes to our equipment, and conduct comparability studies to ensure your product's critical quality attributes are maintained. Our goal is a seamless, efficient, and transparent transfer, minimizing downtime and ensuring your project stays on schedule.
How do you manage project communication and confidentiality?
We provide a 'single-point-of-contact' model. A dedicated, technically-proficient Project Manager (PM) serves as your primary liaison, ensuring clear and consistent communication. You will receive regular progress reports, have scheduled teleconferences, and can reach your PM directly. All project-related information is handled with absolute confidentiality, governed by a strict Confidentiality Disclosure Agreement (CDA). Our IT infrastructure and data management systems are secured to protect your sensitive intellectual property at all times.
Our project is still in early R&D. Can you support non-GMP, research-grade material production?
Yes, absolutely. We are a full-service CRO and CDMO, meaning we support the entire lifecycle. We frequently produce high-quality, research-grade materials (e.g., antibodies, plasmids, proteins) for discovery, proof-of-concept, and preclinical studies. This allows you to leverage our expertise and platform technologies early, and when you are ready to advance towards an IND, we can-seamlessly transition your project from research-grade to a fully cGMP-compliant manufacturing process, saving significant time and reducing tech transfer risks.
What is your approach to intellectual property (IP)?
Our business model is strictly fee-for-service, which means our clients retain 100% ownership of the intellectual property they bring to us and any new IP generated during the project. We do not claim any rights, royalties, or downstream milestones on your molecule or technology. All discoveries, cell lines, process know-how, and data developed specifically for your project are your exclusive property, clearly defined and protected by our service agreement.
Send Inquiry
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
