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:

Protein Therapies:

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

Cell Therapies:

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

Gene Therapies:

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

Vaccines:

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.

WEBINARS

This webinar focuses on the role osmolality plays in developing formulations as new drug classes and compositions are being investigated, as well as helping to maintain specifications during the fill and finish process.

Dive into good pipetting techniques, proper maintenance, and calibration routines to ensure reliable performance of your instrument, as well as explore some of the hidden features contained on the osmometer.

Discuss a high-efficiency solution which ensures plates are populated with high numbers of healthy single cells that grow into resultant colonies for screening, expansion and ultimately selection for master cell banks.

Explore the range of cell growth supplements from SAL and their efficiency and speed advantages at key stages of the cell line development workflow.

In this webinar we review the speed for cell line development to process, maintaining the quality of the cell line process, and the efficiency of cell line development for current and future molecules.

We demonstrate that numerous hiPSC cell lines can be successfully subcloned in a robust and automated fashion, thereby reducing time and cost while most importantly maintaining the integrity of clonal biology.

In this webinar, we explore a platform combination for the high-efficiency, high-viability single-cell cloning of iPSCs to form the Master Cell Bank. This includes an industry-leading clonality documentation package to support future INDs.

Learn about the practicalities of integrating data-centric decision making into the cell therapy development process and how new levels of assurance, data integrity and process management can build into a more confident investigational new drug (IND) submission.

Evaluate the impact of monitoring osmolality during an ultrafiltration/diafiltration step prior to cation exchange capture of monoclonal antibodies from mammalian cell cultures.

A discussion on the use of osmolality in bio-production and in earlier process development, and the case for more frequent, earlier monitoring in cell line development and cell therapy.

VIDEOS

In this video we present data for optimising choices of which combinations of GMP-compatible matrix, dissociation reagents and media can best be employed for single cell cloning of iPSCs in process development.

In this presentation learn more about Solentim ICON™, the world’s first benchtop system for characterizing high productivity clones and STUDIUS™ software, the new standard for cell line development.

Watch Advanced Instrument’s presentation at 5th Bioprocessing of Biotherapeutics and explore four Solentim technologies, that are designed for single cell cloning and assurance of monoclonality.

We demonstrate a platform combination of Solentim instrumentation (the VIPS™) and soluble matrix (MatriClone™, based on laminin) for the high-efficiency, high-viability single-cell cloning of iPSCs to form the Master Cell Bank.

Learn how these two new products work to provide a new data-driven workflow for the development of modern cell-based therapies.

The automation-friendly OsmoTECH HT, the only plate-based micro-osmometer, is designed in a 96 well format that ensures efficiency and acceleration of osmolality testing in early upstream process development, formulation development and stability testing.

This virtual demonstration and overview of the OsmoTECH XT demonstrates how easy the instrument is to use and explains more about its key features. Increase your productivity and reliability with powerful freezing point depression technology for osmolality measurement with the OsmoTECH XT.

Increase your productivity and reliability with powerful freezing point depression technology for osmolality measurement with the all-new OsmoTECH XT single-sample osmometer.  The OsmoTECH XT measures the widest variety of sample types (high concentration, high viscosity) accurately across bioprocessing and cell & gene therapy workflows.

Combining ease-of-use with features that streamline compliance with regulatory standards, the OsmoTECH Single-Sample Micro-Osmometer gives biotech and food and beverage labs the insight into their materials and processes to ensure quality while maximizing productivity.

Designed to meet the high sample throughput, regulatory compliance (including 21 CFR part 11), and data management needs of busy bioprocessing and biomanufacturing labs, the OsmoTECH PRO Multi-Sample Micro-Osmometer combines ease-of-use with accurate and precise osmolality measurements for reliable and reproducible results.

CONTACT INFORMATION

Advanced Instruments, Inc.

2 Technology Way

Norwood, MA 02062

UNITED STATES

Phone: (781) 320-9000

Contact: Shweta Nair

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