The primary focus is on chromatography, specifically using monolithic columns. Within Cornerstone Biomanufacturing Development Services, technologies such as tangential flow filtration (TFF), filtration, and clarification are also addressed. In Cornerstone Biomanufacturing Development Services, the focus is on the in-house developed liquid chromatography (LC) system, complemented by a variety of different and orthogonal analytical and biochemical methods.

Yes, purification processes are highly scalable for commercial production due to the use of advanced monolithic chromatography columns. These columns are available in a variety of sizes, ranging from 1 mL to 40 L, and feature channel sizes of 1.3μm, 2μm, or 6μm. Offered in both cGMP and non-GMP compliant formats, they support a broad spectrum of chemistries, including ion exchange (IEX), hydrophobic interaction (HIC), and affinity chromatography. For screening applications, a small CIMmic disk with a 0.1 mL bed volume and 2μm channel size is available. The scalability from 1 mL to 40 L makes these processes ideal for research, screening, process development, pilot projects, and full-scale manufacturing.

Cornerstone Biomanufacturing Development Services offers Process Development, Analytical Development, and Custom Monolith Development and Manufacture.

Purifying large biomolecules, especially those used in cell and gene therapy (CGT) and vaccines, presents unique challenges due to their delicate nature and distinct behaviour compared to traditional monoclonal antibodies (mAbs). These innovative biomolecule modalities, such as viral vectors, nucleic acids, and viruses, often require specialized purification techniques, as conventional methods may not be sufficient. Additionally, the lack of established purification platforms and comprehensive process monitoring, and analytics further complicate the purification process. Cornerstone Biomanufacturing Development Services excel in overcoming these challenges by providing state-of-the-art solutions for the production, purification, and analysis of large biomolecules. The services facilitate the swift and efficient integration of these solutions into customer processes, ensuring effective, robust, and scalable purification outcomes.

Support and expertise during the development and implementation of purification processes are provided through a combination of resources, knowledge, and technical solutions, ensuring timely delivery of high-quality final products. Leveraging extensive experience in cell and gene therapy, vaccines, and other therapeutic areas, the focus is on large biomolecules like viral vectors, viruses, nucleic acids, exosomes, and bacteriophages. With unmatched expertise in CIM monoliths, the services accelerate customers’ path to clinical trials, quickly deliver scalable and robust processes, and improve yield and purity.  Our Cornerstone Services also help reduce process costs (COGs) and provide rapid, accurate analytics for product and process monitoring and control. This approach optimizes outcomes for monolith-based processes and can lead to the development of new monoliths to better serve unmet needs and emerging molecules.

To initiate discussions with a customer, a Non-Disclosure Agreement (NDA) is typically required. This NDA is often on the side of the customer to protect their material, knowledge, and intellectual property (IP). If an NDA is not already in place, Sartorius has templates available to expedite the process. Additionally, before any material is shipped, a Material Transfer Agreement (MTA) must be signed. For more comprehensive projects, a Master Service Agreement (MSA) or a work order may also be necessary, especially if the project is technically challenging and could generate new IP.

Over 50 full-time employees at Sartorius BIA Separations are dedicated to Cornerstone Biomanufacturing Development Services. The team is organized into three main organizational units. Team members not only work on customer projects but also engage in internal research for new product, process, and method development. Additionally, they are involved in technology exploration, training, education, and patent work.

Cornerstone Biomanufacturing Development Services focus on surpassing the minimum standards set by regulations. They prioritize meeting and exceeding the specific purity criteria established by customers, which has proven advantageous in the past. This approach involves implementing advanced purification techniques, rigorous quality control measures, and continuous process optimization to achieve purity levels higher than those mandated by regulatory bodies.

Our facilities are located in Ajdovscina, Slovenia. We can support you with process development in our modern, fully-equipped BSL 1 and 2 facilities. Take a virtual tour of our laboratories.

We have successfully collaborated with several companies. You can read what our partners say about us here. We have collected highlights from their feedback: