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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8 Reasons Why You Can't Miss BPI West | Plus! Register by Friday, 1/22 and Save $400

8 Reasons Why You Can't Afford to Miss BPI West:

1. First and only phase-based format event that fosters the collective sharing ideas, strategies and solutions across departments to improve speed, cost and quality at every stage of development
2. Breakdown the barriers and collaborate across stages of development to achieve end-to-end integration
3. Discover the latest breakthroughs on successfully implementing continuous processes and linking them together to achieve fully continuous processing from cell culture through to drug substance
4. Accelerate the design and development of novel drug substances for next generation therapeutics by integrating candidate selection and early development
5. Develop strategies for fast tracking early stage biologics and managing the life cycle of a break through therapy designated product
6. Speed up and streamline the transition into development by utilizing manufacturability assessments, automation, and QbD in late stage discovery and R&D
7. Implement disruptive technologies and achieve operational excellence to drive manufacturing efficiencies and minimize costs
8. Uncover the future of single-use systems and next generation facility design, modelling and management in current and emerging markets

Want to learn more about the event? Download the brochure.

Register by this Friday, January 22nd and receive up to $400 in savings - Use the code BPIWEST16BL to save.

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Analytics for Modern Bioprocess Development

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Analytics for Modern Bioprocess Development.

Analytics for Modern Bioprocess Development: Data Driven

Like most other industries growing within the rapidly changing information era, the bioindustry is generating more data than it ever has before. But meaningful information — that which can be linked to process knowledge and, ultimately, process control — is useful only with a robust and efficient data acquisition system. As Gernot John (director of marketing and innovation at PreSens) observes, the underlying factors supporting improved data acquisition in the industry include an increased interest in switching from offline to online measurements, scalability (miniaturization) of analytical instrumentation, and the ongoing change from analog to digital signal transmission.

“Determining the type of process data you need to evaluate — whether it’s quality data, discrete, or online measurements, and/or batch-record data — begins by asking ‘What are we trying to achieve?’” notes Justin Neway, PhD (general manager, operations intelligence and senior fellow, Accelerys Science Council, at Accelrys). He identifies at least four drivers in the need for process informatics. The first is a need to reduce process variability by improving process understanding (which is the touchstone of PAT and QbD), implementing robust design processes, and using online instrumentation. “When QbD came out, it started to sound a bit more pragmatic than PAT. Then the industry started to see the connection between it and PAT, and the industry began actually producing useful outcomes. Now, with the aim of process robustness, it becomes much more business oriented,” says Neway. He points out that a robust process reduces business risk by decreasing supply chain risk. It also can improve profitability and decrease patient safety issues and risks of 483s and FDA warning letters.

Another driver for process informatics is the need for transparency in outsourcing relationships. “That’s not just about cost. It’s about companies specializing in their core area,” says Neway. Much of the renewed emphasis on contract relationships stems from a 2013 FDA draft guidance on quality agreements (2) “The phrase I love in that document is that the FDA considers contractors ‘an extension of the manufacturer’s own facility’” says Neway. With that statement, the agency solidifies the union between sponsor company and contract organization — they are one in the same.

A third driver is the bioindustry’s need for collaboration. Certainly that applies to the partnership between a sponsor company and a contractor, but it holds true for internal collaborations as well. Those types of collaborations can be tough for two reasons, says Neway. “First: You need process development (where the process is designed and scaled up) to collaborate with quality (which takes the responsibility for minimizing risks to patients) and manufacturing (where the process is operated repeatedly at commercial scale and needs support from those who designed it). Second: You need to have those collaborations on a global scale. Email is not enough — you need an environment where people can dive in and work on the same data regardless of time zone, department, even what company logo they’re working under. That is one of the big drivers for process informatics”

The last is the bioindustry’s need for knowledge capture, transfer, and management. Experienced professionals are retiring from the industry, taking with them the process knowledge and expertise that much new hires still needs to embody. “That means knowledge needs to transfer from more-experienced people to less-experienced people as efficiently as possible,” says Neway. This last point is especially important for connecting the operations data and measurements data between, for example, quality laboratories working with laboratory information system (LIMS) and process batch-scale operations working with batch record systems and data historians. People tend to act in silos. “Their LIMS system is organized to identify and manage samples, test protocols, operators, standards, and provide reports of all the results of all the samples. It was not built with an organization that reflects the production process.”

You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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