Better Together—Collaborative Design Drives Advances in Biopharmaceutical Testing
Major technological improvements to osmolality testing workflows are rooted in customer collaborations
Quality control testing and other applications throughout the biopharmaceutical industry use osmolality as a key indicator, which measures the amount of solute in a solvent consistently regardless of temperature or pH.
A global leader in osmolality testing, Advanced Instruments is uniquely tuned to customer needs—developing targeted solutions in biopharma from drug discovery to process development to manufacturing based on customer pain points. Their OsmoTECH® portfolio of osmometers, which have been designed in response to and in close collaboration with customers, demonstrate the value and innovation achievable with this approach. They provide advanced solutions for analysis of challenging sample types and increased throughput while meeting the demands inherent to regulated environments.
Improving analysis of viscous and high-concentration samples
In bioproduction, solution concentrations are trending upward from raw materials to final products. This trend is particularly prominent in formulation, where, for example, demand for more subcutaneous injectable options have led to a push for higher concentration protein and drug products.
High concentration and/or viscous samples are problematic for older analytical technologies, resulting in poor performance and reliability of testing equipment.
Advanced Instruments developed the OsmoTECH XT Single-Sample Micro-osmometer (for extended testing) while working with customers on technological solutions for these sample types and application needs. With it, customers are able to measure high viscosity and high concentration samples within an operating range more than twice that of its counterparts—0-4000 mOsm/kg of H2O—using just 20 µl of sample to minimize waste.
This freezing point depression osmometer achieves its wide testing range through advancements in intelligent freezing technology, including an optimized cooling engine, and a positive displacement sampler. The technology offers consistent, reliable readings across the testing range, and excels at precision analysis of samples with complex characteristics or complex matrices, including cryopreservatives and concentrated solutions of sugars, proteins, large molecules, and oligonucleotides.
In a collaborative comparison study with researchers at the Jefferson Institute for Bioprocessing, the OsmoTECH XT measured osmolality of concentrated multiclonal antibody samples with higher accuracy and precision than a vapor pressure depression osmometer, the previous standby for such samples.
Increasing osmometer throughput
Bioprocess development, including cell line development and early process development, relies on high-throughput and complex workflows. Optimization is particularly important in formulation development workflows that require evaluation of many different solutions quickly.
Advanced Instruments found that formulation labs were frustrated by limitations of time-consuming manual work and by repeatability issues in automation attempts. The biggest unmet need was accurate and precise osmolality measurements with high inter- and intra-run repeatability across large sample numbers. Sample volume was also a particular testing constraint in downstream buffer and formulation development, due to the need to run multiple analyses on formulations.
Based on their discussions with customers, Advanced Instruments developed the OsmoTECH HT Automated Micro-osmometer, which supports automation and accepts 96-well plates to drastically increase throughput to accelerate scale-up. Features like the ability to load two plates at a time and the capacity to run 1,000 samples before changing consumables were designed to reduce hands-on time. To improve automation, the instrument pipettes appropriate sample volumes and is self-cleaning, which combined with a custom evaporation plate cover, improves repeatability, reliability, and confidence in results. Conserving valuable sample material is achieved through 50 µl sample volumes. Effective data management is addressed with customizable templates that can be stored or imported onto the device, automatic, secure data archival, and integration with data management systems, LIMS, and ELN for greater security using OPC-UA communication.
Advanced Instruments works directly with biopharma labs and companies to find solutions for application, process, or workflow optimization while ensuring compliance to the latest regulatory requirements. As a result of work with a global CDMO requiring adherence to data integrity guidance, the full OsmoTECH portfolio incorporates robust digital data integrity and management features for regulated environments, ensuring 21 CFR Part 11, EU Annex 11, and US Pharmacopeia compliant features. These features include sample traceability with integrated barcode scanner, complete, time-stamped audit trails with usage, role, and action records capturing reasoning for setting changes, and integrated and secure data management and integration.
Their work on the OsmoTECH lineup highlights Advanced Instruments continuing tradition of collaboration to identify and troubleshoot new applications and uses that will ultimately improve their customers’ workflows.
Contact Advanced Instruments to collaborate and learn more at https://www.aicompanies.com/intelligent-osmometers
