The Cornerstone® methods ensure fast and reliable in-process monitoring for process development and quality control. Chromatographic analytical methods are rigorously tested and validated to ensure robustness and reliability.
To facilitate process analytics, PATfix is provided, an advanced chromatographic analytical platform designed to enhance performance and extend capabilities beyond conventional systems. The PATfix system integrates robust hardware with multiple detectors, intuitive software, and various chromatographic methods to address a wide range of specific user requirements. Continue reading to learn how our services for process analytics solve critical challenges.
Modality-Specific Analytics Services:
Analytical methods are critically important in process development, supporting product manufacturing, process characterization, and optimization, ensuring reliable implementation under GMP conditions. These methods assist in maintaining product quality, safety, and efficacy in the drug development process. Gene therapy and vaccine development encounter numerous analytical challenges that need to be addressed during the process development stages.
Cornerstone® Analytics Services can assist with:
Comprehensive Toolset
Process analytics require a broad set of analytical tools to build the production process understanding and product knowledge necessary to advance gene therapies and vaccines through to the clinical stage.
We provide customized and innovative analytical methods to ensure the quality and safety of gene therapies and vaccines. PATfix analytical system, which consists of expert software and multiple detectors such as UV, fluorescence, light scattering, pH, and conductivity, provides a platform for the implementation of customized analytical methods. In combination with monolithic columns of various chemistries, the PATfix system enables fast development and implementation of analytical chromatography for any drug substance.
Rapid and Robust Analytical Methods
A major hurdle in the development of robust drug manufacturing processes is the lack of rapid and reliable analytical methods. Without quick assays, understanding of process parameters and their impact on product quality is limited without the availability of quick assays. Many assays are adapted from conventional, time-consuming analytical methods.
Our analytical chromatographic methods are specifically developed for the identification and quantification of large biomolecules in complex mixtures. The methods are developed with a focus on speed and reliability and identification of a wide range of species in a single analytical run. Typically, the methods’ analytical runtime is between five to twenty minutes.
For the determination of full capsids, our methods are ten times faster than the conventional ones, e.g., ELISA and PCR.
Our 15-minute AEX method provides analytical information equivalent to that obtained from other more lengthy methods, such as SDS-PAGE, ELISA, capillary electrophoresis, q/ddPCR, and AGE.
For other analytical applications such as pDNA, AAV, and mRNA, analytical run times from five to twenty minutes
Cost-Effective Methods
The high cost of gene therapies is significantly driven by the lack of rapid and reliable analytics for process development and monitoring in drug manufacturing.
Our PATfix system, in combination with CIMac columns, offers cost-effective and time-efficient analytical methods for various biomolecules, such as AAVs, pDNA, mRNA, LNPs, and others. It only takes twenty minutes to determine the ratio of empty/full AAV capsids and only eight minutes to quantify all nucleotides, capping reagents, and mRNA in IVT reactions.
Our AEX method for AAVs significantly reduces cost and turnaround time when compared to conventional methods such as ELISA, PCR, ultracentrifuge, AGE, and PAGE.
Expertise
Effective collaboration among researchers is essential for advancing the understanding of complex gene therapy processes and for developing robust innovative analytical strategies. In large companies, departmental silos often hinder collaboration, making it difficult to integrate diverse analytical methods. Smaller companies, on the other hand, may lack the broad expertise needed.
Our Analytical Development team can bridge collaboration and expertise gaps in gene therapy and vaccine analytics. We have conducted over 100 early-stage feasibility studies and successfully transferred more than 30 pDNA, mRNA, AAV, and other virus processes to customers’ GMP environment.
Our strong pipeline of analytical methods development, including a recent focus on LNPs, keeps us at the forefront of analytical innovation. We collaborate with universities and the biotech industry to develop and refine our PATfix analytical platforms through extensive testing of a diverse range of samples. With over 200 publications and novel application notes published in the last ten years, we are deeply committed to advancing chromatographic biomolecules analytics.
Achieving Regulatory Compliance
Regulatory requirements for viral vectors are becoming increasingly stringent. As analytical capabilities improve, regulators demand more effective monitoring and characterization of drug products.
Our innovative methods are verified through validation protocols following FDA and EMA guidelines, which include assessing specificity, confirming linearity, and determining the Limit of Detection (LOD) and Limit of Quantification (LOQ). We ensure the accuracy, precision, and robustness of columns, buffers, and PATfix systems. Sample and buffer stabilities are rigorously tested to ensure reliable performance for the entire range of process conditions. By adhering to the validation protocols, we provide effective monitoring and characterization of process and product consistency, quality, safety, and meeting regulatory demands.
Hear from Our Customers
Do You Have a Question?
FAQ About Analytics Development Services
We routinely offer method development for various target molecules. Methods are developed using monolithic columns of different chemistry modalities. All analytical methods are validated following FDA and EMA guidelines.
Method development and validation typically take up to 3 months.
We offer routine analytical methods for PATfix AAV, pDNA, mRNA, and LNP platforms. We provide services for the development of customer-tailed analytical methods. We support the chromatographic results with orthogonal analytics such as agarose and gel capillary electrophoresis, NTA, nanodrop, Mass photometry, dPCR, ELISA, and more.
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.
Consult Our Experts
Our experts would be happy to discuss your project. Fill the contact form below or send us an email to cornerstone@biaseparations.com
