ABOUT ADVANCED INSTRUMENTS
At Advanced Instruments, we believe that quality and productivity go hand-in-hand and have built a family of products and services to help biologics manufacturers and process developers ensure the yield, purity, and consistency of biopharmaceutical products through osmolality testing.
Whether you need to maintain optimal cell growth, ensure active pharmaceutical ingredient (API) purity and yield, or confirm quality during fill and finishing, we offer an osmometer that will keep your processes productive and on track, saving time and reducing costly re-work.
Osmolality can be applied across several applications:
When it comes to process development and manufacturing of protein therapeutics, whether you’re making an antibody-based or other protein therapeutic, what you don’t know can slow you down. Osmolality can help you determine if
- Your buffers and media are formulated correctly
- If your solution has unexpected components
- The steps involving solutions–i.e. cell growth, dialysis, chromatography – are proceeding consistently and as expected
When the therapeutic you’re developing is cell-based, constant monitoring to optimize growth and ensure consistent culture conditions throughout multiple stages is critical for success. Osmolality testing can help you determine if:
- Your stem cells at highest viability and product quality levels throughout culture and passaging
- You are ensuring a high rate of cell recovery post-thaw
- If your transduction mechanics are being optimized
Consistency is critical when producing genetic therapies, including viral vector delivery and gene editing. Small deviations in the composition of cell growth media can have unwanted effects on cell density, cell composition, and virus yield. Using osmolality can help your group work towards those goals, as well as answer:
- how to optimize the physiological range for transfection complexes
- identifying media needs
- determining effects of osmotic pressure on the stability of a complex
Osmolality testing is required to ensure that the final vaccine product is safe for administration. The osmolality must be within a physiological range to be introduced in human tissues. There is also evidence that injectable formulations with high osmolality may cause pain at the site of injection.
These are some common use cases for osmolality testing within vaccine development:
- Upstream cell culture and/or cell expansion requires maintaining an environment at the appropriate osmolality for the specific cell type. For those modalities that are cell-based, regular osmolality testing will ensure that the media and environment are optimized.
- Buffers used during any downstream processing should be tested for osmolality to verify the concentrations of the solutions that are meant to protect the drug substance throughout the chromatography and/or filtration operations.
- Final product testing must include osmolality to verify identify and safety of any injectable.
Visit our website, www.aicompanies.com, to learn more about our OsmoTECH ® portfolio of bioprocessing osmometers.
Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.
Explore how implementing a platform that helped a biopharmaceutical company save 6-8 weeks of work whilst still meeting the regulatory requirements.
A biotech company's cell line development team decided to optimize their processes and look for new equipment that could isolate single cells and speed up development.
Dr. Andy Tsun, co-founder and VP of Discovery Biology at Biotheus Inc, shares his company's experience using an accelerated workflow for single-cell cloning including how it helped them obtain an IND.
We explore how the Cell Line Development group at Janssen R&D was able to reduce one of their development processes to a single step thanks to new technology.
FACS Bulk Enrichment In Combination With Cell Cloning Systems Delivers Significant Savings For A CDMO
Learn how the Cell Line Development (CLD) department at Celonic Ag was able to optimize their workflow with new technology geared towards shortening time lines and lightening workload.
Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations.
This study provides preliminary evidence for impact on overall yield, and quality of the AAV due to a timed osmolality shift with and without a feeding step.
Improving Cell Line Development Processes Through Accurate, Low Volume And Rapid Automated Cell Counting And Viability
We will outline the importance of accuracy and efficiency when cell counting and outline how the Viability assay on the ICON can enhance your current processes.
We outline how the range of technologies support single-cell seeding, image based clonality assurance and allow for informed analysis of critical, cell quality attributes.
Methodologies, utilized in CLD, include viable cell counting, confluency, single cell seeding, plate transfer and consolidation, titer assays and microscopy. It is central to this narrative that data from all these aspects are joined together in a single story of a cell’s journey through this process.
Emergent cell therapy companies have an eye on the future production of clinical treatments. Whatever the timescale, the question of when and how to implement practices that will be scalable to cGMP (current Good Manufacturing Practice) often arise.
Development Of A Highly Efficient, Documented Workflow For Making Clonal Cell Banks Of Gene-Edited iPSCs
Cell therapy companies need to adopt robust workflows that are designed to best manage consistency, quality of product and meet with appropriate regulatory requirements and manufacturing best practices. We explore the effectiveness of the VIPS + MatriClone workflow for gene-edited hiPSC cells.
Reduce time and cost while most importantly maintaining the cell phenotype and genomic integrity as well as providing documented evidence of cell line clonality with viable, high efficiency single cell cloning of hiPSCs.
Review an effective turnkey solution for generating significantly more viable iPSC clones per plate along with image documentation for their clonal derivation.
Review clonality and improved outgrowth for HEK 293 cells when developing stable producer cell lines for viral vector production in gene therapy.
Cloning efficiency is often overlooked in the cell line development workflow relative to the single cell isolation step. However, recovery and growth of the single cells is a challenging step in the process.
When it comes to expanding your lab’s capacity, updating existing methods or even starting from scratch you need new technology integration to be simple, quick and professional.
Scientists are constantly striving to develop the highest producing clones and to do it faster. We now demonstrate how this can be achieved by using only a handful of cloning plates.
Here we detail the osmolality testing of various formulations containing sodium hyaluronate, with a range of viscosities, including semi-solid gels.