Tailored GMP Proteins
From development to Manufacturing
We specialize in custom production of GMP-grade proteins, tailored to meet the quality, documentation, and flexibility requirements of teams sourcing critical raw materials for pharma, biotech, and life science applications.
Whether you need a second supplier or are building a new process from scratch, we offer GMP-grade solutions for difficult-to-express proteins — designed to support and expand your product catalogue.
This include enzymes, affinity ligands, and growth factors used in manufacturing of advanced therapies such as cell and gene therapies.
Why Choose Bioneer for your GMP Proteins?
- GMP-grade quality – Our team follows GMP guidelines, with quality safeguarded by our robust Quality Management System (QMS), based on ISO 9001 principles. We are regularly audited by both customers and government authorities, ensuring consistent standards for regulated applications such as cell and gene therapy, food enzymes, and biosolutions.
- Fully customized production – You get tailored protein development from gene to GMP-grade material.
- Expertise in difficult proteins – We specialize in expressing complex and low-yield proteins that require advanced techniques.
- End-to-end service – From early process development to GMP manufacturing, we support you through the full journey.
- Reliable dual sourcing – We act as a dependable second source to help mitigate supply chain risks for critical proteins.
- Europe-based facilities– We operate out of Denmark, ensuring high standards through strong regulatory compliance.
FAQ: Our GMP protein solutions
Service-Specific Questions
Can you work with our internal process or tech transfer an existing one?
Yes, we can develop a new process or tech transfer your existing process.
Which expression systems do you offer?
For GMP-grade protein production, we are specialized in using microbial expression systems, with particular experience with E. coli. We provide access to commercially available expression systems as well as to our proprietary license-free platforms, the Bioneer E-c System™ for E. coli and the Bioneer Lactococcus lactis P170 System™. We can also work with your preferred microbial expression system.
For non-GMP applications we also offer mammalian expression systems at small scale (up to 30L).
Do you offer off-the-shelf GMP proteins?
No, we primarily produce custom recombinant GMP-grade proteins for clients for commercial use.
Do you offer sterile fill/finish services?
Yes. We provide sterile fill/finish services conducted in a monitored LAF bench within a controlled clean environment (up to 900 vials).
What is the typical timeline for development and GMP-grade production?
The standard timeline for developing and producing a GMP-grade, soluble, and purifiable protein is typically 9–12 months from project initiation to GMP release. However, timelines can vary significantly depending on the protein’s complexity and specific project requirements.
How frequently is your QMS audited?
Our QMS undergoes internal and external audits at least annually. We are also open to client-specific audit discussions based on project scope and regulatory requirements.
What batch sizes and production scales can you support?
In a given year, we can support production of up to 2000 L for a given product. Our largest bioreactor size is 50 L (working volume).
Can you handle proteins expressed as inclusion bodies and provide solubilization/refolding support?
Absolutely. This is one of our core areas of expertise. We offer comprehensive services for solubilization, refolding, purification, and characterization of proteins expressed as inclusion bodies.
How do you ensure project transparency and communication throughout development and manufacturing?
Each project is assigned a dedicated project manager, and we maintain regular update meetings to ensure transparency. We pride ourselves on being collaborative, flexible, and aligned with your internal team.
What regulatory support or documentation can you provide (e.g., Certificates of Analysis, Batch Records)?
We provide full batch documentation, including Certificates of Analysis (CoA), batch records, development reports, and other technical documentation. Additional regulatory support can be provided upon request.
Can you perform stability studies?
Yes. We conduct both accelerated and long-term stability studies in accordance with regulatory expectations and your project needs.
Can you accommodate custom QC assay development?
Yes. Our team has extensive experience in in-vitro modeling and the development of customized assays, including potency assays and product-specific quality control methods.
Can you manufacture APIs?
While we cannot currently manufacture for clinical trials, we have previously delivered materials for toxicology and preclinical studies, and can manufacture under a controlled quality system suitable for early-stage regulatory submissions.
Practical Questions
Can I get a consultation to discuss my project?
Yes. By briefly filling out our contact form on this page, we’ll set up a no-obligation consultation to discuss your needs. We’re always happy to explore solutions and help you find the best path forward.
What typical information do you need to start a project?
The gene sequence is the primary requirement to start the project. However, the more information you can provide — such as expression conditions, tested purification methods, etc— the smoother and more efficient the project will be. A more developed starting point often means faster timelines and lower overall costs.
Contact us for a free consultation
Let’s discuss how we can support your projects with tailored, GMP-compliant protein manufacturing solutions.
For further information
please contact:
Brahim Gargouri, Ph.D.
Sr. Business Development
Manager
