Manufacturing
Bioneer A/S offers comprehensive CDMO services to support your protein development needs from initial concept through to production.
Building on 30+ years of R&D experience in developing robust manufacturing processes for proteins, we continue to expand our services. We offer end-2-end services on both microbial and mammalian platforms including upstream processing (USP), downstream processing (DSP), and characterization. Furthermore, we offer formulation developments for proteins from storage buffers to clinical formulations.
- Our microbial platform is well-renowned for commercial supply of high-quality process enzymes/ ancillary proteins used in the manufacturing of vaccines, APIs, and cell- and gene therapies. With our expertise in expression, re-folding, and purification, we have furthermore produced a number of ‘difficult’ proteins (API’s) for pre-clinical studies. Recently we have more than doubled our capacity by adding new dedicated manufacturing suites for more efficacious operations.
- Our offering on the mammalian platform is expanding. Our efficient CHO-based expression platform can quickly produce a number of modalities including mAb’s, ADC’s, Bispecifics, and more. Currently we are implementing parallel screening capabilities to speed up developments of your drug candidates even further.
We strive to make your priorities our priorities in order to deliver high-quality materials and flexible solutions that are tailored to your needs and timelines.
We offer high quality project management where flexibility, quality, and reliability towards our customers are our key priorities.
Our capabilities encompass Process Development, GMP Manufacturing and non-GMP manufacturing accommodating scales up to 50 liters.
Process Development
Bioneer offers a complete suite of development services, guiding your project from gene through to recombinant protein manufacturing. We have vast experience in developing a wide range of protein modalities including, cytokines, hormones, antibodies (mAbs/Fabs) and antibody drug conjugates (ADCs), growth factors, fusion proteins, enzymes, serpins and more.
We support all steps involved in efficient process development and offer flexible entry and exit points to optimize the progress of your project and to enable critical manufacturing decision-making.
Our expertise and capabilities span both microbial and mammalian platforms ensuring delivery of high-quality proteins.
GMP Manufacturing – Microbial
With over 25 years of experience as supplier of marketed process enzymes, Bioneer’s Microbial manufacturing services include commercial manufacturing of GMP-grade process proteins (ancillary proteins) and manufacturing of drug substances for non-clinical use.
We operate with dedicated up- and downstream suites. Our upstream suites are equipped with 50 L stainless steel fermentors and we can currently handle refolding volumes up to 100 L. Our downstream suites are equipped with a number of Âkta and TFF systems.
Our high quality is safeguarded by Bioneer’s well established Quality Management System (QMS). We develop robust, scalable, and fully documented processes and associated control strategies that ensure the production of high-quality, consistent materials. Additionally, we can integrate established processes through tech transfer, ensuring a seamless transition and reliable supply.
We are equipped to transfer your cell bank, your process, and associated documentation to CMO’s of your preference for larger scale cGMP manufacturing.
Please contact Business Development Manager, Ryan Jeffrey Polito by phone or email to discuss how we can support your GMP manufacturing needs.
Non-GMP Manufacturing – Microbial/Mammalian
Bioneer’s non-GMP manufacturing services deliver high-quality materials for drug discovery and non-clinical studies as well as for diagnostic applications. Offering flexible and scalable solutions, we provide production scales up to 50 liters in microbial systems and up to 30 liters in mammalian systems. We work closely with biotech companies from their early beginnings and with industry to support their CMC needs.
We can customize your production to meet your specific requirements with various purity and characterization options. We deliver high-quality materials, ensure rapid turnaround and cost-effective solutions, with the flexibility to provide different levels of documentation. Whether you require material for early-stage research, non-clinical studies, or diagnostics, Bioneer’s non-GMP services are designed to support your project efficiently and reliably.
We are equipped to transfer your cell bank, your process and associated documentation to CMO’s of your preference for larger scale cGMP manufacturing.
Please contact Business Development Manager, Ryan Jeffrey Polito by phone or email if you want to know more about how our non-GMP services can meet your specific requirements.
