Non-Antibody Purification

The Precision X Platform

Advantages of Artificial Protein A Scaffolds

Precision X affinity ligands are small (~6.5 kDa), selective and stable proteins based on our proprietary artificial Protein A scaffold. They no longer have to bind to antibodies’ Fc parts, but instead we engineer new, specific binding characteristics. We also offer adjustable affinities and pH elution profiles, while preventing off-target binding. Our Precision X ligands and matrices possess exceptional binding capacities, high caustic and chemical stability to withstand harsh cleaning-in-place procedures in dozens of sequential downstream processing cycles, for low cost of goods.

Finally, our affinity resins are amenable to generic Protein A leaching assays and can be flexibly used in analytical applications as well.

Precision Capturing® Advantages:

•   Selective binding to targets from all biological product classes

•   High binding capacity

•   High chemical and proteolytic stability

•   No internal Cysteines for site-specific matrix-coupling

•   Adjustable mild elution conditions

•   Amenable to generic Protein A leaching assays

•   Ligands also usable for analytical applications

NAVIGO Precision X Ligand 400x600px
Precision X Ligand based on artificial Protein A scaffold
NAVIGO Content Breit 1280x600 02

Ligand Discovery

We have implemented and over years continuously optimized, a powerful scaffold technology platform which yields high-quality Precision X ligands against the target of choice.

Libraries

High quality and diverse libraries of artificial Protein A are generated by randomization of carefully selected surface-exposed residues. Each randomized position can comprise all natural amino acids (except Cysteine) which leads to large combinatorial libraries with complexities of 1010 to 1012 different variants each. These high-quality libraries are constantly expanded and are the crucial starting point for ligand discovery programs.

Selection and Screening

During the subsequent selection process, both phage display and ribosome display technologies are deployed to yield ligand-enriched selection pools. Out of these, our fully automated high-throughput screening (HTS) platform then identifies the desired Precision X ligands by rapid screening of up to 15.000 binders per day. The most promising leads are then selected for further development.

Specifically, the affinity ligands are coupled to a solid chromatography support (e.g. beads) to generate the corresponding custom affinity matrices (resins, membranes, etc.). These are then rigorously tested for their performance in biologics downstream processing. Following Precision X ligand and matrix scale-up and validation, the clients’ custom affinity chromatography solution is ready for clinical and commercial non-Fc biologics manufacturing.

High quality libraries are the key to our success.

NAVIGO High Quality Libraries 450x1280px
Artificial Protein A Scaffolds are used to build different libraries.

Precision Capturing® DSP Characteristics

Selectivity, Purity and Yield

Typically, we obtain greater than 95% purity and yield after a single Precision Capturing® step, as confirmed by a number of clients.

Binding Capacity

Binding capacity varies, dependent on target protein characteristics, bead-matrix, and Precision X ligand features. For most recombinant protein targets, we see competitive double-digit gram per liter DBC10 values.

Cycle Numbers & Caustic Stability

Precision X resins are characterized by an extraordinary stability under repeated, harsh alkaline cleaning in place (CIP) conditions for 50-150 downstream process cycles and cost-effective downstream processing.

Matrix Scale-Up and Commercial Supply

Precision X matrices are scalable for large-scale commercial biologics downstream processing. Navigo Proteins works together with renowned manufacturing partners to develop the affinity matrix manufacturing and to deliver Precision X matrices at large scale and consistent quality for commercial biologics GMP purification.

Timelines

Precision X ligand discovery and development of small-scale test matrices takes three to five months to deliver to the client for in-house testing. After that resin scale-up and validation is taken on by one of our trusted manufacturing partners, which takes up to seven months. Intermittent supply of resin in liter scale is possible. The finished resin for GMP downstream processing is then commercially available for purchase after nine to twelve months.

Generic Leaching Assay

Precision X affinity ligands are compatible with commercial, regulatory accepted Protein A leaching assays. There is no need to develop a custom assay from scratch.

Elution Conditions

Precision X custom affinity matrices enable mild elution conditions. This is achieved by engineering of the respective affinity ligands and buffer optimization.

Solid Chromatography Support

All Precision X ligands can specifically be coupled to any solid chromatography support, such as any type of beads, various membranes, or any other suitable DSP structure.

Partnering

Navigo provides a solid bi-lateral agreement framework for our customers that ranges from ligand discovery, resin development, scale-up and validation to GMP compatible resin media.

Intellectual Property

Navigo Proteins pursues a stringent policy of patenting its proprietary products and technology. The Precision Capturing® technology is proprietary to Navigo Proteins. Precision X ligands resulting from the platform are/will be protected by patents. We grant licenses for the use of Precision X ligands to confer competitive, long term advantages to our custom affinity downstream processing clients.