iSpeak Blog

Are You Prepared for the Changes in Biopharmaceutical Manufacturing?

Darren M. Dasburg, P.E.
Are You Prepared for the Changes in Biopharmaceutical Manufacturing?

Soon we’ll be gathering on a virtual scale with all our biotech colleagues in ISPE. Never daunted by the challenge of the pandemic, ISPE went right to work on this conference once the crisis hit. This is my fifth conference on the planning group, and I have to say the virtual world we are building is looking very good. And why wouldn’t it? We have veterans from all parts of the biopharmaceutical and pharmaceutical industry who will simply be exporting their knowledge via video conference rather than live on stage. This is something we’ve all become accustomed to in our sequestered states. I’ve done three of these virtual conferences already and have to say the flow and knowledge transfer impressed me. Sure, I can’t shake a lot of hands and speak face-to-face but knowing everyone is dealing with the same challenge it truly feels collegial. Hopefully in the final production, we will find ways to see each other on virtually.


Huge economic impacts like the pandemic often create new businesses and I’m interested to see what new businesses spring up. From chemical cleaning solutions to the convertible businesses that move on a dime from one business to another still fully using their assets is remarkable to me. Would you have imagined whiskey makers shifting overnight to make hand sanitizer? I recently saw a presentation format where the speakers are presented in holographic form. It was very convincing and of course their slides were right behind them and it looked just like a live presentation. My only hope is that sports don’t go this route.

Back to ISPE; if you read Robert Dream‘s recent blog then you know the numbers of new cell and gene therapies that are upon us. With 7000 genetic disorders affecting 30 million Americans and more than 100 million worldwide, we have considerable work to do to get ready. Today we have already entered 2900 clinical trials for gene therapies alone. What’s truly amazing and true to the ISPE mission is the disruption to the manufacturing facilities and supply chains that we have become used to. No longer are huge bioreactors and miles of stainless steel facilities necessary to make these therapies as they are often targeted for a single patient and done in single use disposable systems. Supply chains that were once measured in months of stored medicines are now time clocked down to the hour for the benefit of the patients and their hospital placements for treatments. Packaging and marketing materials related to the products are non-existent so whole complexities are removed. We are also seeing an unprecedented level of new therapies that will require more than 10,000 clinical patients just this decade for the more than 1,050 clinical studies identified at this time. These new therapies come with odd configurations including viral vectors, plasmids and the cell or gene therapy insertion. When people look at the math to affect this delivery, it is easy to calculate more than 1,000 new manufacturing facilities being built in various parts of the world. What will be great for us is that most of these will be much more representative of lab scale and easier to assemble in a timeline and cost. Certainly, don’t forget the 600 - 700 clinical trials arising out of COVID-19 pandemic. This will certainly be a calling for the pharma industry and it’s great to see pharma in a positive light again.

In light of the pandemic, I’m interested in seeing many emerging employee candidates who are interested in pursuing vaccines and lab testing as a career frontier. Never before has the pharma industry risen to the challenge of a virus in a stronger way. I know from working with many people through various portions of their career that making a difference in the world means a lot. Joining a cause is as important as picking the right company. For newcomers to ISPE, I’m hopeful that many conversations will ensue about the opportunities that may arise and I expect there will be many.

So once again, the gathering at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference really represents an opportunity for people to increase their learning and prepare their organizations for the changes ahead. I really look forward to seeing all of you in that virtual format on 1-2 June and look forward to your feedback on this year’s conference.

Learn More