“5 Questions With…” is a weekly BioBuzz sequence the place we attain out to fascinating folks within the BioHealth Capital Area to share a bit about themselves, their work, and possibly one thing utterly unrelated. March is WOMEN’S HISTORY MONTH and BioBuzz will rejoice by that includes Ladies within the BioHealth trade all month, particularly in “5 Questions With…”. This week we proceed the sequence with Danielle Kalkofen, High quality Management Scientist, Vigene Biosciences.
Danielle Kalkofen is a molecular cell biologist and biochemist with 15 years of trade and educational expertise. In 2015, she turned her focus to organic assay growth, main cross-functional groups to develop, validate, and commercialize new pathogen detection assay merchandise. Then in 2019, Danielle moved into analytical assay growth, the place she works as a part of a multidisciplinary crew to create a portfolio of cGMP-compliant assays to help in delivering constant, high-quality viral-vector gene remedy merchandise. Danielle holds a Ph.D. in Molecular and Cell Biology from Cornell College and a B.A. of Biochemistry and B.A. of Biology from St. Mary’s Faculty of Maryland.
1. Please introduce your self to our viewers with a glance again at your training and profession.
To begin with, thanks for this chance to take part in BioBuzz’s “5 Questions With” sequence. I’m each thrilled and proud to be a part of the colourful BioHealth Capital Area neighborhood.
My training and profession have developed in a considerably natural vogue with my love of studying a driving drive. As a baby, I used to be fascinated with the pure world. I needed to know the way it all labored! This in the end led me to pursue a profession in science. What could possibly be higher than discovering new info and establishing new details for a residing?
My faculty training and early analysis alternatives in sphingolipid metabolism and Gaucher illness sparked my curiosity within the genetics and pathophysiology of metabolic ailments. Throughout my post-undergraduate analysis on the NIH, I spotted that I needed to grasp higher the mobile mechanisms that went awry in these ailments. This pushed me to acquire my doctorate in molecular cell biology and biochemistry at Cornell College.
On the finish of my doctoral work, I used to be able to discover a method to make use of my amassed information to profit others. I entered right into a joint-postdoctoral fellowship between the College of Maryland Baltimore and PathSensors to develop new cell-based biosensor assays for environmental pathogen and toxin detection. Inside a 12 months, I joined PathSensors as an assay growth scientist, a job that enormously expanded my horizons past the bench. Not solely did I develop and validate assays, however I interacted with shoppers and trade stakeholders to study their wants. I labored with totally different departments comparable to engineering, manufacturing, advertising and marketing, and enterprise growth to assist create a brand new portfolio of merchandise and get them to market. I loved being a part of such a extremely cross-functional crew and discovering that there have been some ways I may use my coaching outdoors of the lab.
Nevertheless, I nonetheless discovered myself drawn to metabolic ailments and their rising gene remedy therapies. So, when a possibility arose in 2019, I joined the High quality Management and Analytical Providers division at Vigene Biosciences, a gene remedy CDMO.
2. You might be at present a High quality Management Scientist with Vigene Biosciences. Stroll us by way of your position and a typical day in your world.
As a QC Scientist, my job is to make sure Vigene’s constantly high-quality gene remedy merchandise. This position’s core duty is to carry out cGMP-compliant analytical testing to verify the id and characterize the efficiency and purity of the merchandise. To perform this, my teammates and I exploit quite a lot of abilities and put on a number of hats each day that goes far past routine pattern testing.
We always develop and validate new assays as the sphere, expertise, and regulatory pointers evolve and handle our shoppers’ particular wants. We offer intensive technical and scientific help to our inside manufacturing groups, enterprise growth group, and shoppers. We assist guarantee the suitable checks and product specs are chosen, give knowledge interpretation and proposals, and furnish documentation for our shoppers’ regulatory filings. At any given level we’re supporting about 10-15 totally different energetic tasks in numerous phases from course of growth to routine cGMP manufacturing. It’s a fast-paced however rewarding surroundings, to say the least!
3. Vigene is rising and not too long ago introduced an growth main to just about 250 new jobs. Discuss what it’s like working for a rising firm right here within the BioHealth Capital Area and what this growth means.
Within the quick time since I joined Vigene, we’ve doubled our workforce and greater than doubled our manufacturing area. With our new commercialization facility opening, we’ve expanded our manufacturing area by over 60%. By 2025, we’ll double our workforce once more as we carry our new facility on-line. Evidently, we’re experiencing great progress, so it’s an thrilling time for us.
Our regular progress is because of the quickly rising demand for cell and gene remedy merchandise. From 2012 to 2017, there have been over 2,000 cell and gene therapies present process medical trials worldwide, and at present, there are roughly 20 merchandise available on the market. By 2025 the FDA expects to approve as much as 20 new cell and gene remedy merchandise per 12 months. And it’s estimated that the worldwide gene remedy market will develop at almost 30% yearly for the following a number of years.
Whereas some have acknowledged this to be overly optimistic, there isn’t any query that the trade is burgeoning. This latest growth of our manufacturing area and expertise will enable us to higher serve and help extra shoppers, drive course of innovation that may make manufacturing extra environment friendly, and decrease price obstacles. This may in the end assist obtain our purpose of constructing cell and gene remedy reasonably priced for everybody and get much-needed life-saving therapies to sufferers.
4. Gene Remedy has been a scorching subject prior to now few years. What’s one thing that most individuals don’t find out about it that they need to?
The thought of gene remedy was conceived within the Nineteen Sixties, and the primary gene remedy medical trial began within the late ’80s. However for all the many years of cutting-edge analysis and growth, gene remedy remains to be an rising therapy. There’s nonetheless a lot we don’t know in regards to the biology. There’s plenty of room for technological innovation to make safer and extra environment friendly vectors and streamline and optimize manufacturing processes to create constantly high-quality merchandise.
Given the novelty of gene remedy, the regulatory waters are nonetheless a bit murky. Altogether, some could discover this discouraging, however I feel it’s particularly inspiring. It’s a rare likelihood to develop in an trade the place I do know that my contributions could make a distinction. We now have solely scratched the floor of gene remedy’s potential, and I can’t wait to see what the following 10 to twenty years will carry.
5. What’s probably the most fascinating factor you’ve learn or seen not too long ago? Inform us about it.
I’ve an curiosity in herbalism, aromatherapy, and beauty formulation. I spend plenty of my leisure time researching it and experimenting with totally different beauty preparations. Whereas I take pleasure in studying about herbalism’s historic and cultural facets, I “geek out” after I come throughout scientific research and texts.
An enchanting e-book I learn not too long ago known as “The Chemistry of Aromatherapeutic Oils” by E. Pleasure Bowles. The e-book discusses chemical constituents documented in numerous plant extracts and what’s identified about their pharmacological results on human neurobiology and conduct. Sure, it’s nerdy, nevertheless it’s enjoyable to know the science behind why the scent of lavender makes me really feel so relaxed!
Thanks Danielle Kalkofen, High quality Management Scientist, Vigene Biosciences. for collaborating within the ‘5 Questions with BioBuzz’ sequence, and keep tuned for extra interviews with others from throughout the BioHealth Capital Area and past.
Andy has labored with BioBuzz for the final decade to assist unfold the phrase of the BioHealth Capital Area even earlier than it was branded with that title. His background contains years at MedImmune supporting the Business Operations Group earlier than changing into a BioHealth Nomad working with numerous shoppers in Operations, Communications and Strategic Providers.
- 5 Questions with Danielle Kalkofen, Quality Control Scientist, Vigene Biosciences – March 16, 2021
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- 5 Questions with Doug White, Senior Vice President, Devices Business Unit Head, Emergent BioSolutions – February 23, 2021
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