Are You Prepared for the Future of Biomanufacturing?
Jeffery N. Odum, CPIP
The future landscape of biomanufacturing is changing at the most rapid pace in decades, so the biopharmaceutical professional of today must be prepared for what's new on the horizon in facilities and equipment, production, and process technology in order to meet the demand of the quickly evolving science of biologics manufacturing. Manufacturing of medicines and patient treatment tools is a competitive and diverse industry with increasingly complex technologies and operations.
The movement towards the future of biopharma manufacturing is Biotech 4.0 or BioPharm 4.0, and includes approaches such as continuous manufacturing, single-use optimization, and digital revolution. As novel therapies emerge from the clinic, and process technology drives production innovation, biopharmaceutical professionals must be prepared to design, build, and support the advanced and different facilities required to meet both industry and worldwide demand.
Innovation in manufacturing technology and the implementation of advanced automation and data-driven control is allowing companies to decrease risk while driving down cost-of-goods. The advancement of new product modalities is bringing new challenges to facility asset design and operational optimization. Biopharma leaders are faced with the major challenged of discovering these innovative approaches while remaining competitive with the release of previously unconventional and different patient therapies. At the same time, long standing manufacturing platforms such as MAbs are continuing to bring significant impact to the Industry through new approaches to manufacturing.
The 2019 ISPE Biopharmaceutical Manufacturing Conference will have a wide selection of topics and presenters to help you prepare for the new horizon of biopharma. FDA regulators will discuss the impacts of new regulatory guidance, the impacts of ATMPs on manufacturing and supply chain challenges, and case studies on how companies have implemented Biotech 4.0 solutions in their current operations.
Explore the education agenda today to learn more about featured topics like cell and gene therapies, new modalities, and continuous bioprocessing, then secure your seat to the foremost biopharmaceutical event of the year!
A committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) is conducting a study with the aim of producing a consensus report that identifies emerging and upcoming technologies that have the potential to...
In response to the COVID-19 pandemic, several governments are considering legislation or regulatory actions that would require some or all parts of a drug product’s supply chain, e.g., Active Pharmaceutical Ingredients (APIs) and biotherapeutic drug...
As we sat down to write the this blog for iSPEAK to promote the 2020 ISPE Annual Meeting & Expo we wanted to look back over what has happened in the world in the first half of 2020 and to say it has been one for the history books is an understatement, it...