Production challenges of complex molecules and biosimilar development

This week, we hear more from BioProcess International Conference director Michael Keenan.  He looks at how the Bioprocess International Event has strived to reach the needs help companies overcome production challenges and other emerging molecules in the industry such as biosimilars.

What changes or emerging trends have been added to this Bioprocess International program that make it imperative for them to return?

Well, there are a lot of things happening in the field right now, so we really tried to address these through the program. Companies currently are trying to figure out how to overcome production challenges of more complex molecules beyond the traditional monoclonal antibodies. So, we tried to address those in the sessions – the new kinds of complex molecules, infusions and ADCs and bi-specifics and other types of biologicals. 

There is an emerging trend on increased biosimilar development emerging in the industry, so we really tried to address this in the program. We’ve included a number of case studies that and will have speakers addressing ways how that people can prepare their offensive and defensive biosimilar strategies.

Companies are really trying to figure out how to become more flexible and efficient and really adapt to their bioprocesses depending on what the need is for the particular molecule and to give them the greatest flexibility. So, some of the things we’ve done this year in the program is add sessions related to new paradigms emerging in process development and manufacturing. One of the sessions is a new vision for product attribute controls, which is sort of a new approach being developed in the industry where companies can improve their process development and manufacturing operations by really focusing on product attributes. So, that’s one new session this year. 

We’ve also integrated the formulation and delivery track much more comprehensively within the program and that’s an emerging area, as well, that is new. 

We tried to incorporate a lot more interactive discussion sessions in the program. One that I’m pretty excited about is a session on harmonization of single-use systems, which is going to be bringing together key associations – people from the ASTM, PDA, ISPE, ASME BPE Group, BPOG and BPSA. It’s sort of a town-hall forum to discuss harmonization of single use systems with a focus on extractables and leachables. So, that’s another new addition. There are also other discussion sessions on beta testing of new technologies, looking at robust supply chain transparency, capture options and antibody purification and others.

One other final thing that I think is just a really compelling reason why people should come back this year is that we have dramatically increased the number of concrete case studies at the event this year. There are 76 this year, which is a 27% increase over 2012. There are also 96 unpublished data presentations this year, which is a 78% increase over last year. These are presentations that --- information that people can only get if they come to this year’s meeting because they may not be published elsewhere.

This is an excerpt from a podcast interviews series in coordination with BPI Magazine.  To hear the complete podcast along with other speaker interviews, download them by visiting this webpage.




If you'd like to join Michael in Boston this coming September 16-19 at the Bioprocess International Conference, as a reader of this blog when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

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