Sartorius BIA Separations d.o.o.

Core Business and Technology

The company specializes in biomolecule separation and purification processes, focusing on large and complex biological materials that are often difficult to separate using traditional bead-based chromatography resins. BIA Separations??? proprietary technology, CIM (Convective Interaction Media) Monoliths, is the foundation of its product line.

Convective Interaction Media (CIM) Technology

CIM monoliths are distinct from traditional porous particle chromatography columns. They are composed of rigid, porous methacrylate polymers featuring a network of interconnected, large channels, typically ranging in size from 1 to 6 micrometers. This structural difference enables separation via convective mass transfer, which involves the bulk flow of the mobile phase carrying the components directly to the active groups located on the channel surfaces, rather than relying on slow diffusion into porous beads.

This mechanism provides several critical advantages in biomanufacturing: * Flow-Rate Independence: The separation performance remains consistent across a wide range of flow rates, allowing for extremely fast processing without sacrificing resolution or dynamic binding capacity, a crucial factor for industrial-scale production. * High-Speed Purification: The ability to operate at high volumetric flow rates significantly reduces processing time, thereby improving overall manufacturing efficiency. * Purification of Large Biomolecules: The large channels minimize steric hindrance, making them ideally suited for the efficient purification of very large, shear-sensitive biomolecules while maintaining their integrity and biological activity. Target molecules include: * Viral Vectors: Adeno-Associated Virus (AAV), Lentivirus, and other vaccine vectors. * Nucleic Acids: Plasmid DNA (pDNA) and Messenger RNA (mRNA). * Nanoparticles: Lipid Nanoparticles (LNP) and Extracellular Vesicles (EVs). * Proteins: Large proteins and Immunoglobulins (IgG, IgM).

Products and Services

The company offers a comprehensive portfolio of products and services spanning the entire biomanufacturing pipeline, from research-scale screening to industrial production.

Products: Monolithic Chromatography Columns and Systems

1. Preparative Chromatography Columns

The CIMmultus Line consists of pre-packed monolithic columns designed for process-scale and large-scale purification. These products are manufactured to eliminate the time-consuming and labor-intensive need for column packing, unpacking, and repacking in downstream purification processes. They serve as robust, single-use, or multi-use tools for the concentration, purification, and removal of contaminants from biological materials.

2. Analytical Chromatography Columns

The CIMac Line of columns are high-performance liquid chromatography (HPLC) tools designed for fast, accurate, and reproducible monitoring of bioprocesses. They are essential for quality control (QC) and process analytical technology (PAT) applications, enabling rapid quantification and analysis of biomolecules to ensure quality and compliance throughout the manufacturing stages.

3. Analytical Systems and Standards

The PATfix System is a dedicated analytical HPLC platform offered for routine gradient separations. It is engineered to fully utilize the speed and resolution of CIMac analytical columns, providing an ideal solution for comprehensive in-process analysis and control. The company also supplies PATfix® Analytical Standards for calibration and validation purposes.

4. Screening Solutions

BIA Separations provides tools for high-throughput screening and method development, such as CIM® Monolithic Well Plates, CIM® Octa, and CIMmic Immobilization Screening solutions. These products accelerate the early stages of process development by allowing for rapid optimization of chromatographic conditions and immobilization chemistry.

Services: Cornerstone Biomanufacturing Development Services

The services division provides specialized expertise in process development, moving customer projects from pre-clinical stages to market supply. These services are branded under the Cornerstone umbrella.

• Process Development Services: The company offers custom-tailored development of purification and separation processes for its key application areas, including:
  • Viruses, Viral-Like Particles (VLPs), and Nanoparticles.
  • Nucleic Acids (pDNA and mRNA).
  • Human Plasma Proteins Fractionation.
• Analytics Development Services: Custom method development for challenging analytical tasks using the CIMac and PATfix platforms, ensuring accurate and compliant analytical methods for quality assurance.
• Technical Support and Training: Comprehensive technical guidance on the use of monoliths, application support, and training for laboratory and production staff.
• Cornerstone® Customized Monolith: A service to develop and supply custom monolithic columns with specialized chemistries to meet unique separation challenges.

The integration of BIA Separations monolithic technology with Sartorius broader portfolio of bioprocessing tools strengthens its position as a key enabler for the production of advanced therapies, including gene and cell therapies, and next-generation vaccines.