Mikart, an oral dosage focused contract development and manufacturing organization (CDMO), is moving beyond generic manufacturing to support customers from non-GMP preclinical work to full-scale GMP commercial volumes with a recently expanded range of capabilities, including formulation development, manufacturing, and serialized packaging. Michelle Hall, Vice President of Marketing at Mikart, shares how customers benefit from its end-to-end service offering. Mikart emphasizes value-added services and transparent, flexible business terms as the key to supporting its customers that rely on outsourcing to bring their candidates to the clinic and the market, with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.
David Alvaro (DA): Mikart has a long history, but things have changed quite a bit recently. Can you set the stage a bit with the company’s story?
Michelle Hall (MH): Mikart was founded in 1975 by the Arteche family, who immigrated to the United States from Cuba in the 1960s. The company has a long history of manufacturing oral solid and non-sterile oral liquid dosage forms, focusing on controlled substances. In 2018, after 43 years in business, the Arteche family attracted a private equity investor. Shortly after that, Mikart transformed to complement its existing core competencies with new capabilities.
DA: Could you elaborate on the transformation that Mikart is currently undergoing?
MH: The company has been undergoing a transformation since 2018 to expand our capabilities. The first part of our transformation was to move further upstream in the drug development workflow and support early-phase clinical programs. In addition to the company’s historical focus on oral solids and oral liquids, the company recently expanded its facilities to include suspensions and is also emphasizing NDA and 505(b)(2) programs.
Another part of our transformation is our focus on pediatric and geriatric dosage forms, which require special equipment, as well as new formulation capabilities. A few years ago, Mikart re-established its deep formulation expertise, including pre-formulation work, formulation development, and analytical methods development in addition to our historical services supporting validation, GMP manufacturing, and serialized packaging. Since 2018, the company has extensively invested in new equipment to support early-phase programs. Investments like that will continue to be part of our capability expansion and transformation.
Our vision is to become a leading, mid-sized CDMO serving virtual to mid-sized pharmaceutical and biotech companies. Mikart’s main focus is the provision of technical operations, CMC support, and formulation development for solid oral and nonsterile liquid programs to drug companies that lack these resources or wish to leverage outside assistance. Often, outside help is faster and more economical than internal resources, considerably shortening time-to-market.
Another part of our transformation is to explore new technologies that would be of interest to our customers.
A good example of our investments is the new capability for liquids and suspensions. That investment was made to better support geriatric and pediatric product development and manufacturing, The new suite and equipment train can support a wide range of manufacturing volumes, from 50 liters up to 4,000 liters. Construction was completed in February 2023 and the suite is nearly done with the qualification of all the new equipment.
Separately, on the packaging side, we added the capability to manufacture liquid dose cups and sachets, which are increasingly popular packaging forms among those patient populations.
DA: How is Mikart leveraging partnerships to expand your capabilities?
MH: By partnering with early-stage innovators, we are expanding our capabilities and offering new solutions to our customers that improve bioavailability and solubility.
For example, in 2022, we formed two new technology partnerships, one with Nano PharmaSolutions and the other with Fluid Pharma. In both cases, Mikart intends to use the proprietary technologies developed by these partners to produce clinical trial materials. Nano PharmaSolutions’ proprietary NanoTransformerTM technology enables the production of nanoemulsions. In contrast, Fluid Pharma’s MicrocoatTM technology allows for making oral liquid modified-release formulations and supports taste-masking for tableted products.
DA: As you have expanded from a more focused offering to an integrated suite of services, our customers are mostly taking advantage of the end-to-end service offering today.
MH: Yes. Mikart today supports customers from pre-formulation through packaging and offers individual services, such as analytical support or packaging solutions. Some customers come to Mikart specifically because we can support their projects from start to finish. Others come for a single service and then gradually rely on our other capabilities (such as in-house stability testing and microbiology) once they see the benefits of working with Mikart and staying with a single provider. Many have recognized the value and additional synergies made possible by working with us across the development cycle.
Overall, most of our customers leverage our full-service offering resulting in lower spending and entering the commercial market faster by dealing with one CDMO that can navigate them through the drug development process.
DA: Would you like to share anything about the team behind the Mikart offering?
MH: At Mikart, we have assembled a diverse team of pharmaceutical professionals committed to helping customers achieve their goals. An example is the composition of our Pharmaceutical Development Services (PDS) team. Several members on the team have over 30 years of experience in oral dosage form development and have worked with various formulation technologies and excipients in projects covering the pre-formulation of novel dosage forms to post-launch support of marketed products. The PDS management team is a client consultant, helping steer them in the right direction and learn the essential questions they should ask to ensure program success.
DA: How does Mikart approach customer relationships? What is your project management strategy and communication style?
MH: Mikart places considerable emphasis on project management with open and transparent communication. After the formal signing of a proposal, each customer is assigned a project manager as their single point of contact and internal advocate. A project team includes Mikart personnel and the customer’s designated representatives. After signing, a kick-off meeting is held with the project team, followed by weekly meetings chaired by the project manager and attended by all project team members. The emphasis is on complete transparency and communication, and our CEO often participates, which can be a rare occurrence at many CDMOs. We feel that the accessibility provides our customers to upper management is another strong differentiator for Mikart and can impact on the success and efficiency of a project and a relationship.
DA: For potential customers who may not know Mikart very well or whose view of the company is out of date, what would you want them to understand about both the present and the future of Mikart?
MH: Potential and existing customers should understand that Mikart is a mid-market CDMO that emphasizes time-to-market, is more economical than larger CDMOs, and has the resources to be technically astute in a fully GMP- compliant environment. We offer large CDMO competencies with the customer service level usually found in smaller organizations.
And as a nimble, midsized CDMO, we value every customer equally and are committed to competently getting each project through the drug development process to commercialization.
DA: Looking at the big picture, what are the most critical dynamics in the industry that Mikart is following to plan your strategy and investments?
MH: The most powerful dynamic is the expanding appetite in the industry for U.S.-based CDMO organizations that can offer services that propel their novel therapeutic development and manufacturing. We see this trend continuing in the small molecule space. As many generic drugs continue to migrate offshore, controlled substances remain in the United States for the U.S. market. Mikart has the expertise, controlled environment, and agency relationships to handle those products competently. Customers who already know about these capabilities benefit by leveraging our expertise in this area. These attributes and others that are planned will remain key differentiators for us.