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In an interview with Jai McIntosh, Editor for EPM, Eric Kaneps, VP, Sales and Marketing at Renaissance Lakewood explores how innovation has been at the heart of the success of the company and the market. He also provides his unique insights into some of the challenges nasal spray developers are currently facing.
Jai: How would you describe Renaissance's mission and values in the pharma manufacturing industry?
Eric Kanpes: As a patient focused organisation, we aspire to bring important life-changing drugs to patients and to fulfil unmet clinical needs across the globe. We pride ourselves on producing safe, innovative, reliable, lifesaving medicines for the benefit of patients on behalf of our customers.
At Renaissance Lakewood, we have four core commitments that inform our values:
1. Patients are at the centre of everything we do
2. Employees are treated with integrity, and respect
3. We are committed to superior ethical performance
4. We aspire to be upstanding corporate, cultural, and healthcare citizens
Our values are all about teamwork, showing up for each other, being accountable, and always trying to be our best. By upholding these commitments and having our values guide every decision we make, we support our clients in delivering their pioneering new products to market with regulatory approval so they can make an impact on patients' lives.
Jai: Can you provide a brief overview of Renaissance's journey and key milestones?
Eric Kaneps: Renaissance Lakewood, LLC is a US-based CDMO (contract development and manufacturing organisation) specialising in nasal sprays. I originally joined the company in 2001, when ‘Renaissance Lakewood’ was called ‘DPT Lakewood’, owned by the large dermatologic group, DPT Laboratories. In 2012, DPT was acquired by Renaissance Acquisition Holdings, LLC, a portfolio company held by RoundTable Healthcare Partners, a private equity company focused on healthcare investments. In mid-2016, the dermatologic division was divested to Mylan, Inc. and DPT Lakewood, LLC was renamed and repositioned as ‘Renaissance Lakewood, LLC’, reflecting our rebirth as a new standalone company.
Throughout all these changes, one aspect remained consistent: For over 25 years, we have effectively supported the development and manufacture of our client’s nasal sprays and sterile products.
In the early 2000’s, Renaissance Lakewood was mainly focused in the over-the-counter (OTC) medicine manufacturing space while supporting some unique pharmaceutical preparations. We later divested our OTC business and pivoted to prescription pharmaceuticals, and more specifically, nasal and aseptic fill/finish dosage forms. This allowed Renaissance Lakewood to further sharpen our expertise on nasal development and delivery. We tapped into the prescription nasal spray market during its early stages when it was an emerging delivery system recognising that drug-device combination nasal sprays offered something truly unique. Intranasal delivery provides many patient-centric benefits, including relative ease-of-use for self-administration, as well as enabling rapid and high systemic availability while avoiding the first-pass metabolism by the liver.
Beginning in 2020, we further narrowed our focus on two offerings: aseptic development and manufacturing for preservative-free multi-dose nasal and injectable therapeutics, as well as non-sterile manufacturing for microdose and preserved multi-dose nasal & oral sprays. Although we were previously involved in several different treatment areas across the sector such as sterile topical ointments and ophthalmic drops, our expertise was spread too broadly. By narrowing our offering, we were able to focus our business model and provide best-in-class service in nasal and injectable development and manufacturing.
Jai: The pharma industry is rapidly evolving. How does Renaissance stay at the forefront of innovation in manufacturing, and how does this benefit patients?
Eric Kaneps: When it comes to nasal development and manufacturing, we have always been at the forefront of innovation. Since day one, developing partnerships with leading device manufacturers has led to innovation at Renaissance Lakewood and has been key to our success. By working together, we can help realise the commercial potential of our clients’ novel formulations. With an established micro-dose platform and other unique devices entering the market, we can make a real difference in the lives of patients, offering them broader treatment options and the potential for greater therapeutic benefits.
Over time, the market has become noticeably more competitive, further emphasising the need to remain at the forefront of innovation. However, it is important to remember that adopting innovation can be both high risk and high reward. Many of the products we manufacture are lifesaving, and as such, a defective product can have significant implications for patients and the marketer. Three years ago, we made the bold decision to purchase a pioneering manufacturing asset that was like nothing else available in the market from a throughput and quality perspective.
In a fast-evolving delivery system like nasal sprays, you must never get complacent. Contract manufacturing companies must always be striving for improvement. I've been in this business long enough and have seen other companies fall into the trap of stagnation. Without reinvesting or planning, companies in this space will quickly be outmanoeuvred. Innovation is at the heart of Renaissance Lakewood, so I am confident in its continued strong position leading the field.
Jai: What do you think is the reason for the growth in nasal sprays in the United States?
Eric Kaneps: The European market has embraced nasal drug delivery for years. One can find multiple nasal sprays widely available in European pharmacies, while until recently, one could find just a few in US pharmacies, typically in the allergy space. With over-the-counter naloxone nasal spray being widely available, US consumers are normalising to the non-allergy nasal applications and are embracing this delivery format, leading to the growth of this sector.
The driver behind this change rests in the fact that delivery via injection or rectal delivery is generally unpleasant, requires training and is commonly associated with fear and discomfort. Nasal sprays can provide needle-like uptake while offering an improved patient experience with ease of use.
The US pharma industry is waking up to the need for more patient-centric, innovative options as well as more sophisticated delivery methods to provide patients with these benefits.
Jai: Do you feel the pressure to innovate to ensure the company remains in line with sustainability goals?
Eric Kaneps: Sustainability is a hot topic in Europe, and we embrace the opportunity to support our clients in their green initiatives. As one example, we have developed a more efficient and compact packaging offering. With our reduced packaging footprint, we can get these devices into a smaller blister and carton, taking up less shipping space, as well as reducing material consumption and waste.
The key to a successful partnership that embraces sustainability relies on partnership with the client, where both parties take steps to ensure practices strive towards eco-friendly goals.
Jai: What challenges have Renaissance encountered in pharmaceutical manufacturing, and how have these been overcome?
Eric Kaneps: The growth of the business has been rapid. As a result, a predominant hurdle has been keeping up with demand to ensure we meet the needs of customers and patients. Embracing innovation in our strategies and methods has been key to overcoming this issue.
Additionally, complexity in packaging is a challenge many developers and manufacturers face, especially since not every market wants everything written in English. Effectively packing for different countries requires a thorough understanding of the regulatory requirements and quality expectations for each, as well as the need to adopt different strategies for small countries and large countries. We're currently refining our approach to address these matters to keep up with the expanding demand that comes from being a global player. Despite these ”growing pains”, providing global support has added tremendous value to us and our partners.
Jai: Could you share a specific instance where Renaissance's technological advancements have positively influenced the manufacturing process, ensuring quality and efficiency?
Eric Kaneps: Renaissance Lakewood provides a full-service offering, so we can support our clients from concept all the way to approval. For a CDMO to effectively support a project, they must work closely together with the client. This ensures the free flow of information from the early stages of development to provide a greater understanding of the characteristics of the API and help elucidate a clear pathway to commercialisation. With this in mind, we always aim to be involved from day one.
As a specialist in nasal spray development and manufacturing, we get to work on some very exciting, innovative projects that have the potential to radically change how some illnesses are treated. We are driven by the knowledge that the products we develop and manufacture really do make a difference and know that many of the programs we have supported are truly changing the quality of people's lives.
In addition to bringing our client’s innovations to fruition, Renaissance Lakewood embraces advancements in manufacturing technology and methodology to advance the nasal spray space. As mentioned earlier, by designing a device assembly and packaging line unlike any other, with 14 different quality and process checks built in, we can ensure that the product we're making is of the highest quality with the capacity to support the market growth we are seeing.