1. Congratulations on becoming part of Catalent. Can you give us some insight into the acquisition and what it means for Paragon Bioservice’s customers?
Paragon has been private equity-backed for the past five years. The hypergrowth Paragon is experiencing has created a huge demand for additional capital spending and new funding. The acquisition by Catalent is great news for Paragon, as it will strengthen Paragon’s solid foundation and enable us to continue our unapparelled growth with continued investment in the gene therapy space. Additionally, Catalent's expertise in manufacturing, scale-up and market launch will ensure that our customers have a strong partner with them all the way through their product life cycle.
2. Do you now have plans to expand nationally or even globally?
In April 2019, Paragon announced plans to open its second GMP manufacturing facility directly behind their current commercial-scale facility. Paragon’s strong manufacturing partnership with Sarepta Therapeutics, Inc., has driven the need for additional dedicated facilities for Sarepta’s gene therapy candidates.
Paragon’s new, state-of-the-art commercial manufacturing center is located near the Baltimore-Washington International Airport, close to its process development facility in the University Maryland Biopark in Baltimore City. The center includes the newly launched building equipped for phase II through commercial gene therapy manufacturing and the second undeveloped building, both of which will allow for future joint ventures between Paragon and Serepta.
This large-scale production campus has the potential for more than 425,000 square feet of manufacturing space upon completion of construction. The facility will offer individualized manufacturing suites specially designed to handle the unique needs of gene therapy products.
For more detail, see Paragon’s press release.
3. If companies like Novartis and bluebird bio are building their own manufacturing facilities to de-risk and ensure enough capacity for commercial scale, what does that mean for the CMO market?
The gene therapy clinical pipeline is experiencing a high growth phase. Coming on the heels of the several market approvals of gene therapy products in 2017 and the influx of VC funding for gene therapy companies, the demand for viral vector manufacturing capacity has dramatically increased. With this type of demand, there is a need for established partners with scale-up expertise. The challenges of building and staffing a gene therapy development and manufacturing facility are complex. This allows CMOs to offer a critical piece of the puzzle for many gene therapy innovators. We can offer them dedicated GMP-compliant space, scale-up expertise and customized downstream processing without the added time, costs and risks of building a new viral facility.
4. There is a significant backlog in the manufacture and supply of viral vectors and one of the pressures causing this is high volumes needed per dose. How close are we to solving this and will we be able to significantly increase yields?
Here at Paragon and overall in the viral vector space, we are constantly making incremental improvements in yields. We can achieve 10-20% increases today and while that is substantial, the industry will need to see logarithmic increases to really meet the demand. Even with a 30% increase in yield, it gets counter-balanced with 30% increase in demand. What we hope to see someday is the 110-fold growth similar to what took place in the monoclonal antibody space. I don’t think this exponential increase is likely in the near term. This will more likely be realized in 5-10 years. Selected pressure causes an adapted response and I know that along the way of this gene therapy wave someone will push a cell to make more product.
5. You have spent an extensive proportion of your career at Paragon, how has the rapid development of the wider complex biopharma and, more specifically, the advanced therapies industry shaped the organization?
At Paragon, we support some of the most transformative therapies in the clinical pipeline today. To think that we are going beyond palliative care to actual cures is extraordinary. Our customers are in a position to change the fate or destiny of patients. Take Muscular Dystrophy for example; this is a disease where boys rarely survived beyond their mid-20s. Now there is potential with the delivery of a single dose before they even show symptoms that they will be cured. That is miraculous. At Paragon, we say that we are ‘manufacturing miracles’, and I feel strongly that this dedication to our customers and their life-saving medicines is what has shaped our company.