Since its founding in 1975, Mikart, LLC has been a recognized leader in providing contract manufacturing, product development, and packaging services to the pharmaceutical industry. In September 2018 the private equity firm Nautic Partners acquired the Atlanta, GA-based contract development and manufacturing organization (CDMO). At closing of the deal, Nautic named Michael Kallelis as Mikart’s new chief executive.

Mikart’s services include formulation development, clinical trial supplies, regulatory filing support, analytical services, clinical manufacturing, commercial manufacturing, and packaging. The company can make products in tablet, capsule, or liquid form and its packaging capabilities include bottle filling, blister packaging, pouch and foil strip packs, and cartoning and tray packaging. It operates 234,000 square feet of facilities in Atlanta that meet and exceed current FDA and cGMP standards.

Contract Pharma recently had the chance to talk about solid dose processing and packaging trends with Mikart’s senior vice president of business development, John M. Phillips, as well as other industry trends and challenges and Mikart’s response to them.

Contract Pharma (CP): How would you describe the current state of the oral solid dose manufacturing and packaging market?

John Phillips (JP): The outsourcing of development and manufacturing activities for oral solid dosage forms is on the rise. Although the new drug discovery pipeline is declining, the need for a lifecycle management strategy to address off-patent drug competition as an example is increasing. Companies are looking at current molecules for newer indications in the same or different therapeutic areas. We are also seeing an upturn in pediatric-friendly presentations such as oral solutions, dissolvable tablets, sprinkles, mini-tablets, and orally disintegrating tablets. In addition to the demand for lifecycle management strategies, controlled-release dosage forms, fixed-dose combinations, and formats such as multi-layer tablets or multiparticulate drug delivery is increasing.

CP: What are three key trends and/or drivers in the contract solid dosage business from both a processing and packaging perspective?

JP: There is a growing emphasis on continuous manufacturing (CM) of solid oral dosage forms but the industry is still investing and advancing in batch processing for clinical and commercial products. While the adoption of CM continues, there are great opportunities for operational efficiency (OE) and batch optimization to meet the large and small-scale manufacturing flexibility a CDMO needs to have in this market.

A methodical approach to lifecycle management is growing in popularity. Some of the most widely used lifecycle management strategies are controlled-release, fixed-dose combinations, and pediatric. pediatric presentations such as oral solutions, dissolvable tablets, sprinkles, mini-tablets, and orally disintegrating tablets. Other lifecycle management extensions applied are controlled-release, and solubility enhancement formulations to reduce the dose of existing drugs.

Another trend is the technological advancements in drug delivery such as combination of drug and medical device, ingestible sensors (digital pill) to help with greater medication adherence, and biodegradable sensors.

CP: Where are the current opportunities for growth? Conversely, what are the major challenges or obstacles in the market?

JP: As a CDMO we need to be able to accommodate large- and small-scale manufacturing and have the experience to manufacture the multiple presentations such as oral solutions, dissolvable tablets, sprinkles, mini-tablets, and orally disintegrating tablets. In addition, controlled-release dosage forms, fixed-dose combinations, and formats such as multi-layer tablets or multiparticulate drug delivery is increasing in popularity.

CP: What are the most recent advances in oral solid drug delivery technology?

JP: I continue to see advancements in drug delivery such as the combination of drugs and medical devices, ingestible sensors (digital pill) to help with greater medication adherence, and biodegradable sensors.

CP: What does the year ahead hold regarding serialization compliance and/or non-compliance? How is the supply chain being impacted?

JP: The addition of serialization has increased the complexity of packaging compliance from a quality standpoint. With multiple verifications of the product, supply chain integrity should be taking a very positive step forward. 

Mikart is 2023 compliant and will be implementing a level 3 solution called Open SiteMaster (OSM) 2.0 from Optel to manage all packaging lines in one harmonious system. OSM will enable us to manage recipes, master data, serial number cache, and broken flow on each packaging line. We are also implementing a warehouse serialization solution from Optel called KOMPANO, which will provide multiple warehouse actions such as printing, capturing, verifying, aggregating, shipping, decommissioning, receiving, managing returns and submitting serial numbers in the warehouse. It will aid in our ability to decommission a single serialized product lot and commission it into multiple serialized lots for shipping and track/trace purposes. 

CP: What are Mikart’s plans for future growth?

JP: Since Mikart was acquired last year, we’ve made significant investments in facility modifications, IT systems and people. In addition, we have a new “go to market” strategy in business development that has generated renewed interest in Mikart’s service offerings. The company is now planning to broaden our capabilities to more closely match the needs of the current and future market trends that we’ve been observing.