New Paper From WuXi AppTec On Shortening Timelines For Bioprocessing Of Protein-Based Therapeutics
Cambridge, UK – 1 March, 2016: Sartorius Stedim Biotech (SSB) today announced a new paper entitled, ‘Shortening Timelines for Upstream Bioprocessing of Protein-based Therapeutics’ has been published in the journal, BioPharma Asia. The paper details how scientists at leading Asian pharmaceutical company, WuXi AppTec are using the ambr® 15 automated micro bioreactor system to mimic bench-top and production scale bioreactors, producing comparable results with cell growth, cell metabolism and protein production, including similar protein titre to BIOSTAT® STR single-use bioreactors.
In the article, one case study describes how WuXi AppTec scientists have applied the ambr 15 system to prove similar cell growth and productivity as 1L and 3L bioreactors, with similar pH and pCO2 profiles using three different monoclonal antibody (mAb) expressing Chinese Hamster Ovary (CHO) cell lines.
The paper also details another WuXi AppTec case study using a mAb-expressing CHO cell line in a fed-batch process in ambr 15 micro scale bioreactors, a 7L glass bioreactor, a 10L single-use bioreactor and a 200L single-use BIOSTAT® STR bioreactor (SSB). The results showed that the growth profiles from the ambr 15, bench-top and production scale single-use bioreactors also had good comparability.
The success of the ambr 15 as a bioreactor mimic in these studies is due to a combination of pH & DO control, culture stirring by an impeller and gas supply by sparging, just as in bench-top and manufacturing scale bioreactors. It is these features which allow scientists at WuXi AppTec to move towards replacing their traditional shake flasks and bench top bioreactors with ambr 15, to increase scalability of early stage results and accelerating their bioprocessing workflow.
To request free access to this paper, scientists should click the link: http://www.tapbiosystems.com/tap/cell_culture/ambr15articlereqpr.php
Dr Barney Zoro, ambr 15 Product Manager, at SSB commented: “The large dose volume needed to achieve clinical efficacy and extensive production and purification steps involved, means that manufacturing costs of biologics can be high. These factors are driving the search for methods and systems to reduce the cost of goods (COGs) of producing biologics.”
Dr Zoro added: “This new paper shows how a forward thinking pharma company can reduce the COGs of biologics through an increase in upstream cell culture productivity. By using an automated micro bioreactor system WuXi AppTec’s scientists have demonstrated that bioprocess optimisation no longer needs to be limited by availability of bench-top bioreactors, operator time or facility infrastructure and this could in future contribute to reducing their development timelines and the manufacturing costs of their protein-based therapies.”
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.”
Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,700 people, and in 2014 earned sales revenue of 683.5 million euros.
ambr® systems are designed and manufactured by TAP Biosystems (now part of the Sartorius Stedim Biotech Group) a leading global provider of automated cell culture and fermentation systems for life science research, development and production. ambr systems are widely used for cell line development and process optimisation at pharmaceutical, biotechnology and academic laboratories. They are proven to provide a reliable model and consistent scalability to a range of upstream processes.
In the article, one case study describes how WuXi AppTec scientists have applied the ambr 15 system to prove similar cell growth and productivity as 1L and 3L bioreactors, with similar pH and pCO2 profiles using three different monoclonal antibody (mAb) expressing Chinese Hamster Ovary (CHO) cell lines.
The paper also details another WuXi AppTec case study using a mAb-expressing CHO cell line in a fed-batch process in ambr 15 micro scale bioreactors, a 7L glass bioreactor, a 10L single-use bioreactor and a 200L single-use BIOSTAT® STR bioreactor (SSB). The results showed that the growth profiles from the ambr 15, bench-top and production scale single-use bioreactors also had good comparability.
The success of the ambr 15 as a bioreactor mimic in these studies is due to a combination of pH & DO control, culture stirring by an impeller and gas supply by sparging, just as in bench-top and manufacturing scale bioreactors. It is these features which allow scientists at WuXi AppTec to move towards replacing their traditional shake flasks and bench top bioreactors with ambr 15, to increase scalability of early stage results and accelerating their bioprocessing workflow.
To request free access to this paper, scientists should click the link: http://www.tapbiosystems.com/tap/cell_culture/ambr15articlereqpr.php
Dr Barney Zoro, ambr 15 Product Manager, at SSB commented: “The large dose volume needed to achieve clinical efficacy and extensive production and purification steps involved, means that manufacturing costs of biologics can be high. These factors are driving the search for methods and systems to reduce the cost of goods (COGs) of producing biologics.”
Dr Zoro added: “This new paper shows how a forward thinking pharma company can reduce the COGs of biologics through an increase in upstream cell culture productivity. By using an automated micro bioreactor system WuXi AppTec’s scientists have demonstrated that bioprocess optimisation no longer needs to be limited by availability of bench-top bioreactors, operator time or facility infrastructure and this could in future contribute to reducing their development timelines and the manufacturing costs of their protein-based therapies.”
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.”
Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,700 people, and in 2014 earned sales revenue of 683.5 million euros.
ambr® systems are designed and manufactured by TAP Biosystems (now part of the Sartorius Stedim Biotech Group) a leading global provider of automated cell culture and fermentation systems for life science research, development and production. ambr systems are widely used for cell line development and process optimisation at pharmaceutical, biotechnology and academic laboratories. They are proven to provide a reliable model and consistent scalability to a range of upstream processes.