Osmolality testing is essential for ensuring yield, purity and consistency of biopharmaceutical formulations. Therefore, osmometers need to meet the needs of biologics manufacturers at each step of the bioprocessing workflow to ensure both productivity and high quality. During the upstream phase, when biologics are initially produced, the focus is on guaranteeing the correct preparation of media, monitoring cellular health and maximizing product yield. During the downstream, or purification, phase, osmolality monitoring ensures the correct preparation and the highest quality of buffers and minimizes the risk of batch failures. During the formulation and fill phase at the end of the process, stability and safety of biologics need to be confirmed during storage, reconstitution and injection. This step is essential for ensuring patient safety and is also an integral part of the final product release specifications.
Bioprocessing workflow: customers’ needs greatly vary
Considering the complexity of this multifaceted bioprocessing workflow, it is evident that customers’ needs vary greatly depending on the stage they are at. They need instruments that perfectly meet their requirements and can be easily integrated in the process from a data management and ease of use perspective.
Process Development is typically time and labor intensive, with challenges at each step. For example, when scientists are optimizing products and processes, osmometers have to work with low sample volumes. Moreover, in the early development phase, high throughput for osmolality testing is required. Testing and screening many samples is essential to reduce risks during the scaling up process. Hence automation – with minimal hands-on-time – brings great benefits and improves productivity. This is why automation is a key feature of Advanced Instruments’ OsmoTECH® PRO, an osmometer that fully meets these testing and screening requirements. It is an accurate, precise and easy to use instrument which uses freezing point depression technology. This osmometer is designed to support busy bioprocessing and manufacturing labs in optimizing and ensuring the quality and consistency of buffers and media while maximizing biologic yield, quality and purity.
“The OsmoTECH PRO provides fast and accurate results that are critical for decision making during development and scale up, using minimal sample volumes,“ says Shweta Nair, Sr. Product Manager for the Bioprocessing Technology Portfolio at Advanced Instruments. “It also secures and manages data electronically, which is crucial for scientists who need to optimize their time at the bench. They can load the sample on the device, start the testing and then walk away and do other things. And when the test results are done, those are sent to the cloud so they can be accessed remotely and securely when needed. So, it’s the whole process which is optimized.”
As companies scale-up from process development to clinical or commercial GMP manufacturing, their requirements change: While they do not need to test different conditions anymore, they do need to work under highly controlled and fixed conditions. The focus here is on reliable, accurate, and precise at-line and on-line monitoring of strict processes. Moreover, data integrity and data compliance become essential parts of the product release process.
OsmoTECH® XT is Advanced Instruments flagship osmometer, offering a versatile sample testing capability for accurate and precise results across a very large range of osmolality (0- 4000 mOsm/kg). It also allows the freezing of complex sample types across the bioprocessing workflow. Like all the other Advanced Instruments osmometers, the OsmoTECH XT can be easily integrated into manufacturer’s workflows, minimizing disruptions to processes and increasing efficiency. “In the industry, we are seeing many new molecules and biologics, often at high concentrations. The OsmoTECH XT is able to accurately and precisely test these samples while ensuring complete data integrity and compliance,” said Nair.
Optimizing Advanced Instruments products: The voice of customers is fully integrated in the development process
In order to ensure all of the different requirements are fully met during the above mentioned process, customers are at the center of all development efforts. In fact, a keystone of Advanced Instruments’ philosophy is close collaboration with its customers. The continuous collection of feedback becomes an essential part of the development process when requirements for new products are established. For this purpose, structured feedback is obtained during the entire lifecycle of a device through interviews, conversations, questionnaires and customer satisfaction surveys. Advanced Instrument continuously evaluates this same feedback throughout the process during all customer touchpoints.