Monday, February 29, 2016

Innovative Technologies, People, and Organizations Drive the Future of Bioprocessing

By  S. Anne Montgomery, Editor in Chief, BioProcess International 

In the 14 years that BioProcess International (BPI) magazine has been around, the biopharmaceutical industry has experienced a dramatic confluence of technologies, analytics, and regulatory initiatives aimed toward accelerating development and commercialization of life-saving biotherapeutics. Although a number of these topics were “on the radar” before the turn of the century, by the time of BPI’s first issue in January of 2003, they were beginning to be discussed in earnest, and references to “disruptive technologies” began to appear in print, online, and conference discussions across development phases.

As revealed in BPI’s article archive the list is impressive and includes, notably
• single-use technologies
• quality-by-design
• process-analytical technologies
• advanced medicines/cell and gene therapies
• antibody–drug conjugates
• biosimilars and biobetters
• immunotherapies
• combination products
• companion diagnostics
• platform analytics and manufacturing technologies
• product life-cycle development
• continuous processing.

We have watched, too, as those innovations spread across the globe into regions not previously considered to be biomanufacturing hubs and as international regulatory agencies sought to harmonize pathways to approval. Different partnering models have emerged with both long- and short-term goals, but many in response to concerns about supply-chain integrity in an era of life-cycle management.

Presenting information and guidance for sorting through these choices of platforms, technologies, and manufacturing models is the continuing work of technical publications and conference presentations. BioProcess International magazine has always benefited from its close collaboration with the Informa conference groups (IIR/IBC) to create separate but compatible content and presentation vehicles. Many of the magazine’s editorial advisors also have served on the conference advisory panels, for example, and industry trends (and the best people to speak and write about them) identified by one group are shared with the other to bring as consistent a message to our readers and event attendees as possible.

Our two annual flagship events — now called BPI West and BPI — pull these interrelated topics together into week-long programs that you don’t want to miss if you need to stay on top of the latest interpretations of these trends. A quick look at the program for the upcoming BPI West (14–17 March 2016 in Oakland, CA) reveals the ongoing impact of the past decade’s advances on the current biopharmaceutical industry. The opening preconference symposia in themselves reflect key areas of attention: innovative approaches and technologies in process development and manufacturing, cell-therapy commercialization, ADC development, and continuous processing. Many elements of those topics were just promising ideas a decade ago, research topics that “might someday” be brought into commercial viability.

Another example is that the Basic Research and Discovery track of this year’s conference is far from the relatively “siloed” research presentations of the past. Speakers here now will stress the needed overlap of development strategies with early risk analysis and process optimization — with their goals (repeating across product classes and development stages) of shortening the times for lead optimization and transition into manufacturing. Enabling technologies incorporate analytical tools that in themselves introduce new questions: How much information is too much? What are we seeing now of contaminants and particulates in marketed products that we didn’t know were there before, and what does that mean for developers of follow-on products? What statistical knowledge for assessing this wealth of data is now required of those entering the industry that was not deemed necessary before?

I urge you to visit the conference site, download the program, and plan to attend sessions that will help you navigate the current and future worlds of biomanufacturing. Network with your peers, among whom are many veterans who helped build our current industry as well as a younger generation who are introducing fresh insights and new ways of implementing technologies and communication tools.

And as you contribute to advancing this new world biomedical approaches, take a look, also, at BPI’s third biennual awards program categories. Our awards are designed to reflect key milestones in the industry, highlight technologies that are making often-disruptive changes in how biopharmaceutical products and modalities are reaching those who desperately need them, and honor companies and people who are building a new world of healthcare options for both regional and global communities.

I have followed the biopharmaceutical industry as an editor since 1988, and I sometimes take a step back and marvel at how far this work has come. Technologies come and go — and some return again, with problems solved and new challenges revealed. Terminology may look the same, but its connotations are sometimes radically different to new generations. As always, communication is key, but exchange of knowledge must be based on shared understanding of terminology and technologies. Plan to join us in March and continue to contribute to these meaningful discussions. Make your mark on the future of biomanufacturing — we need your voice and we want to hear about your experiences.

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