Thinking Ahead: Advanced Biotech Solutions
Optimizing biotechnology processes through customer-centric innovation and comprehensive support.
For many in biologics process development and manufacturing, knowing that your work saves lives, improves health, and alleviates suffering fuels a commitment to quality. But there are times when ensuring quality can feel like it conflicts with the need for speed and efficiency.
Not all osmometers can deliver the same accuracy, precision and speed as those from 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 advanced osmometer that will keep your processes productive and on track, saving time and reducing costly re-work.
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.
- Are all of your buffers and media formulated correctly?
- Does your solution have unexpected components?
- Are all of the steps involving solutions–i.e. cell growth, dialysis, chromatography–proceeding consistently and as expected?
With the innovative osmometers from Advanced Instruments, you can gain valuable data for managing process and product quality through a simple 90-second test. Osmolality, the measurement of total solute concentration, is a reliable control specification and in-process parameter that can deliver information across the protein therapeutic process development and manufacturing workflow.
Optimize cell culture conditions to maximize cell density and yield.
Cell Line Development
Cell Culture Monitoring
Monitor buffer composition and processes, such as chromatography and filtration, to ensure protein purity and yield.
Fill & Finish
Monitor and verify the concentration of API and excipients to meet internal quality and regulatory requirements
Filtration and Fill
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.
- Are your stem cells at highest viability and product quality levels throughout culture and passaging?
- Are you ensuring a high rate of cell recovery post-thaw?
- Are the methods and processes used for transduction optimized for your system?
Using osmolality can help your group answer these questions early in the process, ultimately helping you save time, money, and limited or costly reagents. Adding a simple 90-second osmolality measurement to the in-process parameters you measure is a quick and easy way to ensure optimal cell growth, during process development and manufacturing as well as during buffer and media preparation.
With the innovative osmometers from Advanced Instruments, you can keep delicate cells at optimal growth and gain valuable data for managing process and product quality across the cell therapy process development and manufacturing workflow.
Characterize media and optimize transduction of cells with lentivirus to optimize cell viability and size.
Cell Line Development
Cell Culture Monitoring
Optimize downstream processing by confirming buffer concentrations and minimizing shock to cells.
Fill & Finish
Monitor and ensure final composition and manage cryopreservation and storage.
Formulation and Fill
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.
- Are you looking for ways to increase vector stability?
- Is your gene therapy group looking for higher transfection efficiency and higher viral vector production?
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
With the innovative osmometers from Advanced Instruments, you can gain valuable data for managing process and product quality through a simple 90-second test. When done right, osmolality, the measurement of total solute concentration, is a reliable control specification and in-process parameter that can deliver information across the gene therapy process development and manufacturing workflow.
Optimize cell culture conditions and media selection to maximize cell density, size and, ultimately, virus yield.
Cell Line Development
Cell Culture Monitoring
Check raw material concentration and perform in-process monitoring of purification and filtration steps to maximize purity, cell/virus stability, and yield.
Fill & Finish
Monitor and ensure final composition, dosage, and stability
Filtration and Fill
Osmolality testing has unlimited applications in areas of personal care and hygiene. Products that come into contact with or penetrate the skin must have an osmolality within a physiological range to avoid damaging cells and tissues. In some instances, slightly hypo- or hyper-osmotic solutions are generated to promote wetting or drying effects. The manufacturing of skincare products, personal lubricants and optical products
One key to a youthful look is healthy and moisturized skin. Proper hydration of skin depends on a balance of water flow into and out of skin cells and, thus, depends on osmolality. Osmolality testing of skincare products provides assurance that the product will have moisturizing effects and serves as a control during the production process.
The osmolality of personal lubricant formulations impacts their effect and safety. The World Health Organization (WHO) stated that the osmolality of these solutions should not exceed 1200 mOsm/kg, with this limit decreasing to a more iso-osmotic level in the future.
Similar value for osmolality testing can be clearly seen in optical applications. Eye drops and other optical products are designed to lubricate or protect the eye. The goal of these solutions (e.g. adding moisture, removing moisture, etc.) dictates an ideal osmolality range.
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.
Vaccines are derived from a variety of sources, both living and synthetic, meaning a variety of bioproduction workflows are required. These workflows include some common use cases for osmolality testing, including the following:
- 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.
Differentiation in use cases for osmolality testing are outlined below:
Monoclonal Antibody Vaccines
Osmolality testing should be performed on hybridoma cell media to ensure optimal antibody production rates.
- The rate of antibody production in hybridoma cells depends on the osmolality of the medium in which the cells are grown.
- The osmotic agent used to affect the osmolality levels also impacts Ab production.
Osmolality testing should be performed on media solutions to optimize cell size and viral vector stability.
- Osmotic pressure affects the size of the morphology of insect cells and viruses.
- The osmolality of the media affects the composition of the lipid bilayer membrane of enveloped viruses. This directly impacts the vector stability.
mRNA and DNA Vaccines
Delivery systems and mechanisms should be tested for osmolality.
- mRNA can be complexed with different agents (e.g. PEI) for delivery within the body. Osmolality impacts the stability of the complex of viral models.
- Osmolality impacts the ability to penetrate the target cell membrane.
COVID-19 vaccine development often falls into these development categories. To better understand how osmolality testing benefits the production of therapies, visit the respective tabs: Protein Therapies, Cell Therapies, Gene Therapies, Oligonucleotides.
An example of an accelerated mRNA vaccine production workflow is below:
(as little as 1 year)
This novel field involves the use of antisense oligonucleotides (ASOs), aptamers, siRNAs, miRNAs and synthetic mRNAs to control the expression of genes that have been associated with diseases. Multiple Advanced Instruments customers within this field use osmometers to verify the concentration of the solutions carrying their precious products. Ultimately, the quality of the drug is dependent on the process controls implemented throughout the workflow. Below are some of the current uses for osmolality testing in this field:
Osmolality specifications for buffers to preserve and protect the critical quality attributes of the product as it is being developed.
Compendial release test needed to confirm the identity and concentration of the oligo product for safe use.
Because this is an emerging field, it comes with a number of development and application challenges:
- Delivery of RNAs across the lipid bilayer and into cells
- Immunogenicity once in the body
- High rates of degradation of oligos by plasma and tissues
Drug delivery into the target cells requires the proper osmotic pressure, similar to the parameters around viral transfection in vector development. The optimal osmolality of the delivery complex (e.g. mRNA:PEI) should be determined and monitored during this process. This specification will provide repeatable successful delivery of the drug.
Advanced Instruments osmometers are simple to use, require very small volumes, and provide results in 90 seconds...Of all the analytical tools used in our lab, Advanced Instruments osmometers were the most reliable.
Gerry Drouillard, Biopharmaceutical Process Engineer
Popular Educational Resources
Not all osmometers can deliver the same accuracy, precision, and speed as the ones from Advanced Instruments. In the resources below you can learn more about the power of measuring osmolality and why the freezing point depression method used in all of Advanced Instruments’ osmometers is considered the industry’s gold standard.
Lack of data integrity is a key reason for breaching compliance. Learn how becoming FDA 21 CFR part 11 compliant can benefit your organization.
Advantages of Freezing Point Depression
Fast and accurate, freezing point depression technology has all of the advantages versus other of osmometry.
Alongside UV absorbance, osmolality is a predictor for model-based real-time monitoring of concentration in protein chromatography.
Osmometers For Biotech
All models support
Pharmacopeia testing guidelines
Being discontinued Dec. 31, 2020
|Best for labs with daily sample processing needs of:||>20/day||>10/day||1-10/day||1-10/day||1-10/day|
|Sample volume||50 µL||30 µL||20 µL||20 µL||250 µL|
|Sample introduction||96 well plate||Sample cup||One-step direct||One-step direct||Sample cup|
|Operating range (mOsm/kg H2O)||0 – 2,000 mOsm/kg H2O||0 – 2,000 mOsm/kg H2O||0 – 4,000 mOsm/kg H2O||0 – 2,000 mOsm/kg H2O||0 – 4,000|
|Test time (seconds)||140||90||Less than 150 in low range, Less than 190 in high range||90||120|
|Compliance Support Features|
|Supports 21 CFR Part 11 & EU Annex 11 compliance|
|Electronic Signature (Review & approve)|
|Supports Pharmacopeia testing guidelines compliance|
|Multi-language touchscreen display|
|User name & password compatibility|
|Automated cleaning between samples|
|Integrated barcode scanner|
|Data Management Features|
|Control device remotely via OPC-UA|
|Webserver for remote data viewing|
|Levels of users access||3 Levels||3 Levels||3 Levels||3 Levles|
|Data Format||.csv & pdf||.csv & pdf||.csv & pdf||.csv & pdf|
|Download Chart as a PDF
Great compliant instrument. Configuration and user setup was a breeze!
Troy Franz, Quality Control Manager, Paragon Bioservices
Get the best performance from your osmometer from the people who designed and built it. We provide a range of services and service plans to meet the different needs of our customers. Our certified Field Service Engineers provide on-site professional support for the installation, training, validation, and maintenance of your osmometers.
Anaerobic Jar Systems
The Anoxomat III anaerobic jar system is an efficient method of bacterial cultivation, creating repeatable environmental conditions for the biotechnology microbiology laboratory. Using the evacuation and replacement method of McIntosh & Fildes, the Anoxomat can create anaerobic, microaerophilic, or custom environments, such as capnophilic. Anoxomat’s easy operation and its built-in quality assurance program guarantees reliable results.
Our ergonomic anaerobic jars provide flexibility and ease-of-use for laboratory technicians while maximizing incubator and laboratory space. All Anoxomat jars are built to meet the highest microbiological and mechanical standards and minimize the risk of oxygen leaks.
The new single use Palladox disposable sachet is designed specifically to work with the Anoxomat System, improving workflow efficiency and simplifying anaerobic culturing. The easy-to-use, single-use catalyst will simplify your anaerobic sample testing by minimizing catalyst handling time. The Palladox sachet reduces the oxygen in the jar in minutes and maintains an anaerobic environment for the duration of incubation.