Taking the plunge into manufacturing is a huge milestone in drug development, and with that huge milestone comes huge regulatory standards that must be met to ensure the product is high quality.
You might think this just involves testing clean rooms for microbial contaminants, but it’s actually much more than that. There are a plethora of things that have to be considered and validated, so much so that it can be overwhelming.
Enter Lifecycle Labs – the new kid on the block in Research Triangle Park that provides high-quality environmental monitoring. Rather than take on the challenge yourself, why not leave the testing to experts in the field?
Having just recently opened its doors (and BioBuzz just recently opening its doors to covering the RTP market), we thought it’d be a great opportunity to talk to co-founders Thomas “Tommy” O’Donnell and Irina Belyakova to learn more about Lifecycle Labs and what makes RTP the place to be.
Tell us Lifecycle Labs’ origin story – what was the motivation behind starting this company, and what lies ahead?
Tommy: I’ve been in the industry for a while, 20+ years, and I always enjoyed the business side of things – growing companies, looking for individuals, etc. I built and sold my first company, Azzur, and after a few years out of the industry I realized that man, I really enjoyed that experience and wanted to get back into it.
I ended up meeting Irina through a mutual company we worked at. We started having conversations about starting your own lab and what all that looks like. We got to know each other and continued to stay in touch, and there eventually came a point where we said, “Hey, let’s talk about actually doing this now.”
Irina: I also have over 20 years of experience in biotech, and I was always working for somebody else at someone else’s company. I always had the itch to be my own boss, but I needed the job stability while I was raising my kids. Now that they’re older, though, when I met Tommy, Ram, and Jason I felt it was the right time to say, “Hey, why not?” So with that I moved from the Kentlands neighborhood in Montgomery County, Maryland to North Carolina.
Tommy: Irina and I had 4 months of ongoing conversations – talking about our plans and where we would set our roots. We officially formed the company in October 2022, and from there it was all about finding the space, getting equipment, and getting our quality systems and SOPs in place. We’re now all set up and ready for business!
Irina: We’re really excited for the year ahead – it’s taken a lot of work to get everything up and running, and we can’t wait to go out into the region, start meeting people, and start bringing on customers.
Can you explain what “Environmental Monitoring” is for our readers who might not be as familiar?
Tommy: Environmental monitoring is necessary to ensure that clean rooms, which are used for the final manufacturing stages of a product, are contaminant-free and controlled. This is critical in order for companies to prove to regulatory authorities that they’re ready for manufacturing.
We do an array of testing and sampling in our lab to make sure clean rooms are free of microbial and viral contaminants that could ruin a product. We also test other parameters such as humidity, temperature, and pressure between rooms. We not only test under static conditions – when no one is present in the rooms – but also when the room is at max capacity. In addition, we also check the HVAC systems, gowning process, cleaning process, training of personnel, and how people behave and do work in the clean room.
Who is your ideal customer?
Tommy: Because clean room validation is critical for biomanufacturing, we’ll be primarily working with industries and biotechs that are in the latter stages of drug development. However, R&D-stage companies that have small clean rooms can certainly also use our services.
What drove you to start the business in RTP vs. other biohubs out there?
Irina: It’s really all about the timing. North Carolina has been a biohub for a while, but it’s still lagging behind other hubs such as Boston/Cambridge and California. Tommy was already in North Carolina doing projects and consulting work, and we started seeing one announcement after another about these multi-billion dollar projects that were getting started.
Not only was NC gaining momentum, but the cost to start up a business is much lower than somewhere like Cambridge. An added plus for me was that my daughter is attending Duke University, so I could be closer to her. All these pieces together just made sense. Once we get our name out there more and people start to know us, there’s plenty of business to be had in this region. That said, though, we’re also able to ship out supplies to do environmental monitoring in locations outside of RTP as well.
What do you think is RTP’s “secret sauce” that differentiates it from other biohubs?
Tommy: We’ve only been here a short time, but I will say there’s a big focus on “gathering places” – people coming together for food and drinks and building community. There have been a lot of events with lots of attendance and participation, and I really hope to see that continue to grow.
Another thing is the “good ol’ boy” network for doing business. I imagine this is largely driven by Southern culture, but down here referrals and knowing people get you a lot further than just having flashy credentials. It’s really important to spend the time to get to know people, their hobbies, their families, etc. With that, the pace is also much slower than in an area like Boston, with more of a focus on building relationships.
What events will you be at in the near future if people want to chat more with you?
Irina: I attend Triangle Biotech Tuesdays gatherings every second Tuesday of each month – I hope to see you there!
Learn more about how Lifecycle Labs can help ensure your clean room is ready for manufacturing.
Lifecycle Labs delivers a comprehensive environmental monitoring (EM) service for GMP clean rooms that provides a one-stop solution for all EM needs. Our service follows the US Pharmacopeia guidelines for EM sampling, and we have the capacity to incubate up to 1,500 EM plates at a time. We offer routine and dynamic EM sampling, as well as support during execution of EM performance qualification (PQ).
Our service includes growth promotion tests for culture media, selection of representative colonies on EM plates, microbial identification using third-party labs, maintenance of microbial libraries for in-house isolates, routine trending of EM data, and quarterly reports for EM programs. We guarantee summary reports within 24 hours of incubation completion so that our clients can access timely and accurate data to support their compliance requirements. Our EM service provides a cost-effective and efficient solution for GMP clean room monitoring, and we are committed to delivering high-quality results to our clients. We also provide incubation of up to 2,000 biological indicators in validated incubators and offer incubation services for Media Fill Containers collected during validation studies of autoclaves, depyrogenation ovens, and VHP cycles.
By Sarah Ellinwood
April 20, 2023
Source: https://biobuzz.io/in-conversation-tommy-odonnell-and-irina-belyakova-of-lifecycle-labs/
