The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The small (but mighty) Nicotiana benthamiana plants, busy expressing protein for some of the world’s biggest problems, were described in our last post, where we also touched upon the iBio CMO facility features. Here, they will expand on the true capabilities of the 139,000 square-foot (Texas Big!) manufacturing giant located in Bryan-College Station, Texas.
The iBio CMO facility, a cGMP compliant pharmaceutical manufacturing facility, uses hydroponics to grow well vetted bioreactors (Nicotiana benthamiana plants) in huge grow rooms (featured in last month’s “Pink Room” blog). The iBio structure is called a “hardened facility” meaning that damage by natural forces such as storms and tornados, which could seriously impair traditional greenhouse structures, is less likely. The facility has capability to manufacture up to 300 kg of pure monoclonal antibodies per year using hydroponics and is able to reduce the foot print and increase quality control over plant growth. Because iBio CMO is a multi-use facility, scientists are capable of making multiple products simultaneously or sequentially to respond to changing demand. Not only is the facility capable of producing multiple products, but iBio CMO has the direct ability to commercially manufacture every phase of product, from clinical materials through commercial quantity plant-made pharmaceutical material.
iBio CMO shares its hometown with Texas A&M University System (TAMUS), the fourth-largest university in the United States and the largest university in Texas. The duo has been working together over the past six years and earlier in 2016 they signed a formal joint research development agreement to establish a center of excellence in PMP research and commercialization. The collaboration plans to leverage the research and development resources of TAMUS with the commercial therapeutics and vaccine development and manufacturing capabilities of iBio CMO. The overarching goal of the collaboration is to serve the citizens of Texas, the U.S. and eventually the world, through the rapid development and testing of cost-effective, commercial, therapeutic, and vaccine solutions against diseases that threaten humans and animals.
The flexibility and scalability of facilities such as iBio CMO are critical when producing therapeutics and vaccines to respond to emerging natural or man-made threats. Built-in expansion space allows a 100% increase in bioreactor capacity with the infrastructure challenges of developing new stainless, stirred-tank, bioreactors. With a large-scale facilities and PMP manufacturing platform, the opportunity to develop medical countermeasures to rapidly and effectively respond to global threats and outbreaks is possible. Together with one of the largest universities in the U.S., iBio CMO is finding big solutions for big problems in a big state...well y’all get the idea. Author: Dr. Barry Holtz President, iBio CMO LLC
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...