News | April 29, 2014

Gallus BioPharmaceuticals Utilises ambr15 Micro Bioreactor To Rapidly Optimise Process Development Of Novel Antibodies And Biosimilars

ambr 24way cut_hires (2)

TAP Biosystems, (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cellculture and fermentation systems for life science applications, is delighted to announce its ambr15 micro bioreactor system is being used at the leading US-based Contract Manufacturing Organisation (CMO), Gallus BioPharmaceuticals, LLC (“Gallus”) to optimise process development and clone selection of novel antibody therapeutics and biosimilars.

Gallus’ scientists are using the ambr15 micro bioreactor in their new, state-of-the-art Process Development facility in St. Louis, Missouri. The system is being used for clone selection programmes to determine which CHO cell lines are stable and produce the highest titre mAbs. They are also using the ambr system to optimise media selection and feed strategies for these mAbs, which are being developed as antibody therapeutics and biosimilars for some of the world’s top pharma and biotech firms.

Matt Caple, Scientific Director of Cell Culture Development at Gallus said:“Our clients want high yielding, pure biotherapeutic antibodies that they can take into clinical trials as quickly as possible. However, they often come to us without any process development history for their mAb clones and we have to ensure we build them a robust process.  We used to do this with multiple shake flask and benchtop scale bioreactor runs - in one media development project we performed 1000 shake flasks runs - however, we knew we couldn’t continue to work at this labour-intensive scale.  So we assessed a number of bioreactor models and concluded that the ambr15 system was the right option for us.”

Caple added:“We have now been working with our ambr15 for six months and, from our comparison studies, have seen the titre results of our mAbs correlate well with those we obtained in 50L bioreactors.  We are currently using ambr15 routinely for our bioprocess characterisation work and are looking at using it for perfusion culture modelling. For us, ambr is ‘game changing’ technology, so much so that we are now running it around the clock and are considering buying a second system.”

Dr Barney Zoro, ambr15 Product Manager at TAP Biosystems stated:"We’re delighted that Gallus has integrated the ambr15 system so seamlessly into their new Process Development facility. Their confidence in the system shows scientists that ambr15 is the proven choice for helping to deliver robust, high-performance cell culture processes, especially where biotech and pharma clients are imposing stringent timelines and product quality targets.”

About TAP Biosystems
TAP Biosystems (now part of the Sartorius Stedim Biotech Group) is a leading global provider of automated cell culture and fermentation systems for life science research, development and production.

TAP's systems are in use worldwide at pharmaceutical, biotechnology and academic laboratories, supporting bioprocess development and GMP manufacture of biologics and cell therapies, as well as discovery and stem cell research programmes.

Founded in 1987, the company has offices in the UK and USA, and an extensive network of distributors in Europe and Asia offering pre- and post-sales support. www.tapbiosystems.com

About Gallus BioPharmaceuticals
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients.  Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Stelara and Remicade for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs, and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint. Both sites maintain exemplary quality and regulatory records.

SOURCE: Gallus BioPharmaceuticals