New Sartorius QbD tool supports faster Raman model building
Unlocking the potential of Raman spectroscopy as a high throughput analytical technique for monitoring cell culture in mini bioreactors.
Sartorius has introduced BioPAT Spectro, a Quality by Design (QbD) tool for use with its ambr automated micro and mini bioreactor systems and with the single-use production bioreactors BIOSTAT STR. The new tool offers access to Raman spectroscopy analysis in high throughput process development, supporting faster Raman model building and accelerating scale-up into commercial manufacturing.
Raman spectroscopy is non-invasive and can measure multiple analytes, making it suitable as a Process Analytical Technologies (PAT) method for process control and monitoring of cell cultures. Off-line approaches to obtain and consolidate enough data to produce a robust Raman model can be time‐consuming and costly. The new BioPAT Spectro Tool, can be retrofitted into ambr 15 cell culture and ambr 250 high throughput systems, and enables quick and simple sampling for integrated at-line analysis of a large number of analytes by Raman spectroscopy in a Design of Experiments (DoE) approach.
Consisting of a multi-use flow cell integrated into the ambr analysis module, BioPAT Spectro in ambr has been successfully demonstrated by major pharmaceutical companies and is compatible with Raman spectrometers from Kaiser Optical Systems and Tornado Spectral Systems. The online Raman spectroscopy data alongside data from the ambr process and selected integrated analysers, is automatically collated by the ambr software and can be easily transferred to SIMCA Multivariate Data Analysis (MVDA) software to build robust Raman models.
One benefit of using BioPAT Spectro with ambr system is that all integrated sampling, sample analysis, data collection, and consolidation is automated, making walk-away Raman spectroscopy analysis in high throughput process development a reality. In addition, one ambr run in 24 mini bioreactors can cover a wide design space, rapidly providing all the data required to build robust Raman models to support QbD, in less than half the time of the conventional benchtop approach.
Developed with scalability in mind, BioPAT Spectro’s flow cell’s Raman probe interface and optical path design is identical across scales so it enables time-saving, automated in-line Raman spectroscopy with Sartorius’ BIOSTAT STR single-use bioreactors. The integrated qualified and ready-to-use single-use spectroscopy port in Flexsafe STR bags for BIOSTAT STR bioreactors will be launched in the near future.
"Unlocking the potential of Raman spectroscopy as a high throughput analytical technique for monitoring cell culture in mini bioreactors has been a key goal of process development scientists for a number of years,” commented Dr Svea Cheeseman, Product Manager Process Analytical Technology at Sartorius. “We are showcasing the BioPAT Spectro at IFPAC and BPI West this year and look forward to discussing with scientists how they can use this new analytical technique with ambr systems to build and utilize robust Raman models, in a workflow which will support their QbD programs, while minimizing resource costs and biologics’ manufacturing timelines,” adds Dr Cheeseman.
Related News
-
News AstraZeneca invests in AI collaboration for cancer drug trials
The British-Swedish pharmaceutical giant is partnering with biotechnology firm Immunai Inc to increase the efficiency of some cancer drug trials. -
News Ozempic and Wegovy prices questioned as Novo Nordisk faces US Senate hearing
The CEO of Novo Nordisk was grilled during a US Senate committee hearing on September 24, 2024, in which the exorbitant prices of the Danish company’s blockbuster drugs Ozempic and Wegovy were called into question. -
News The BIOSECURE Act: implications for the pharma supply chain
On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin... -
News On Track at CPHI Milan: Thermo Fisher Scientific Track Sponsor interview
With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma. -
News CPHI Milan Speaker Spotlight: Pharma Manufacturing and Localisation in Africa
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Eli Lilly licenses rheumatoid arthritis manufacturing in Africa
American pharmaceutical company Eli Lilly has signed a partnership with Egyptian organisation Eva Pharma to localise manufacturing of rheumatoid arthritis treatments in Africa. -
Sponsored Content CPHI Online Trend Report: How can flow chemistry help businesses achieve their sustainability goals?
In our latest CPHI Online Trend Report, we partner with Asymchem to understand the innovative potential of flow chemistry for API manufacturing, especially in regards to meeting sustainability goals.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance