This week, SpeakPharma interviews Michael
Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services.
In this exclusive interview, Kallelis
discusses how Mikart maintains its competitive edge through its Pharmaceutical
Development Services team, quality control framework, and commitment to
customized business solutions. Kallelis also explores the company's focus on
liquid suspensions manufacturing, driven by growing demand from aging
populations and pediatric patients, and explains how Mikart balances
traditional family business values with modern innovation.
HIGHLIGHTS// celebrating
its 50th anniversary/ reputation for technical expertise/ how Mikart
maintains its competitive edge
Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?
Over our 50-year
history, we've celebrated many memorable milestones, but one of the most
significant in recent years has been achieving our growth objectives. This
success was driven by the strategic expansion of our Pharmaceutical Development
Services team, the completion of full aggregate serialization in our packaging
department, modernization of our IT systems, enhanced productivity, and our
ability to attract both new and returning customers.
HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of
full aggregate serialization/ attract both new and returning customers
How has Mikart
maintained its competitive edge in a constantly evolving pharmaceutical
landscape?
Our customers
consistently tell us that what sets us apart is our technical expertise, high
service level, and flexible, customized business terms. At the core of our
competitiveness is our focus on Pharmaceutical Development Services (PDS).
Mikart's PDS opinion
leaders are actively engaged in business development and form early,
collaborative relationships with our customers' technical teams. From the
outset, our prospects and clients work directly with Mikart's experienced
formulation chemists, analytical method developers, and process-oriented
engineers to design robust, reproducible, and efficient processes.
This hands-on
development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team.
The result is
disciplined problem-solving, timely FDA submissions, and a
"right-first-time" philosophy that accelerates time-to-market. We
operate with a strong sense of urgency and consistently deliver a high level of
customer satisfaction.
What truly
differentiates Mikart is our commitment to customized business terms that
eliminate common roadblocks seen with other CDMOs. Our secret sauce is our
exceptional service and flexibility in helping our customers bring innovative
medicines to patients.
HIGHLIGHTS// technical expertise, high service level/ flexible, customized business
terms/ comprehensive quality control testing framework/
dedicated Quality Assurance and
Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market
What capabilities
or services does Mikart offer today that didn't exist 10 or 20 years ago?
Mikart was an early
leader in serialization, implementing full capabilities well ahead of the
industry timeline. This proactive approach has kept our packaging team in high
demand. We also upgraded our tablet compression equipment to enhance both speed
and reliability.
To support growing
development needs, we invested in new lab-scale development equipment, unit
dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite
dedicated to closed-system manufacturing of liquids and suspensions.
Most recently, we
launched a multi-million dollar expansion of our packaging lines to support
higher-speed tablet filling, powder-in-bottle formats, and new liquid fill
capabilities.
HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/
multi-million dollar expansion of our packaging lines
Why are liquid
suspensions becoming such a key focus, and how is Mikart positioned?
Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them.
There is growing
industry demand for high-quality suspension manufacturing, driven by the needs
of the aging baby boomer population and pediatric patients. For both groups,
swallowing tablets or capsules can be difficult, making oral liquid suspensions
a more practical alternative.
In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable.
HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions
offer pharmacological advantages/ improve dosing compliance
How does Mikart
balance tradition with innovation to meet modern customer demands?
At Mikart, we work
hard to preserve the values of a traditional family business, even as we
continue to modernize. Our goal is to make every customer feel like they are
our top priority.
Each customer is
supported by a dedicated project manager who serves as their primary point of
contact, along with direct access to key team members across departments. This
structure ensures our customers are never isolated from our subject matter
experts and can get timely, accurate answers to their questions.
We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs.
HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are
never isolated from our subject matter experts/ we rely on market data and
customer trends to guide our investments/ meet real market needs
Looking ahead,
what's in store for Mikart in the next 5-10 years?
Mikart's strategic
plan is now in full motion, and with the momentum we've built, 50 percent
growth is within reach. This projection is backed by a strong pipeline of
annual FDA filings, a growing customer base, and a robust portfolio of active
Pharmaceutical Development Services projects.
As we grow, we remain
committed to delivering exceptional service and continuously evolving to meet
the changing needs of our customers. With renewed
political emphasis on domestic manufacturing for the US market, we are ideally
positioned to support the rapid, cost-effective development and production of
high-quality medicines here at
home.
As we approach our
50th anniversary in the CDMO industry, we celebrate our legacy and look forward
with optimism to the opportunities ahead in the next 5 to 10 years.
HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings
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