Integrated CDMO Services. Adare Does It. Find out How.
Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with small molecule expertise focusing on oral dosage forms. Adare’s specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactures more than 65 products sold by customers worldwide.
Adare Pharma Solutions operates seven facilities in the US and Europe, with nearly 800 global employees. We have the expertise and proven track record to guide projects from clinical research stages through optimization, validation, and approval. Our sites are equipped to facilitate efficient drug product development and manufacturing, maintaining excellent environmental conditions compliant with US and EU cGMP regulations.
With DEA Licenses for the manufacture and testing of controlled substances listed in Schedules II-V, Adare is authorized to develop and produce pain management and CNS therapies. Adare also has dedicated, engineered high potent GMP manufacturing and development areas to handle substances with occupational safety levels down to 1 mcg/m3.
• Tom Sellig, Chief Executive Officer
Tom Sellig brings more than 30 years of global experience in the life sciences industry to Adare, including experience scaling organizations and driving growth in the CDMO and Pharma Services space.
From 2019 to 2021, Tom served as Chief Executive Officer of LabConnect, a clinical trial laboratory services organization. Under his leadership, the company more than doubled in revenue and underwent significant team expansion to meet the growing needs of the biopharma industry.
Prior to LabConnect, Tom was Chief Commercial Officer at ConnectiveRx, where he was responsible for all commercial and customer-facing activity at the patient support and patient access company. Earlier, Tom was Senior Vice President of Global Sales at Patheon, where he played an integral role in the company’s sale to and integration with Thermo Fisher. Previously, he served as the Global Vice President of Sales and Client Services at Covance.
Tom received his bachelor’s degree in Economics from Vanderbilt University and an MBA from New York University.
• Michael Ryan, Chief Financial Officer and Chief Operations Officer
Mike Ryan brings over 20 years of global experience in finance, operations, and mergers & acquisitions, including significant experience operating in a private equity-backed environment.
Mike previously served as President and Chief Operating Officer of the Commercial Division at Syneos Health, where he was responsible for running the day-to-day operations of the division, as well as the oversight and delivery of all the material strategies and commitments to key stakeholders. Prior to his appointment as COO, Mike played increasing roles in operations and finance, serving as the CFO of the company’s largest single business unit and eventually as the Divisional CFO.
Mike began his career with Arthur Andersen working in their public accounting practice. He holds a Bachelor of Science in Business Administration from the University of Notre Dame and is a Certified Public Accountant.
• Giuseppe Di Vincenzo, Chief Strategy Officer
Giuseppe leads our strategy and internal pipeline development teams.
He was previously Vice President, Strategic and Commercial Development at Adare where he was responsible for commercial strategy, marketing, business development and internal pipeline development activities. Prior to that, he was Vice President Global Sales and Strategy at Aptalis Pharmaceutical Technologies. Before joining Aptalis, he held several senior positions at Eurand. He also held roles with Élan Corporation and Arthur D. Little.
Giuseppe holds a degree in Biology from the University Federico II of Naples, Italy and a Master of Business Administration from the London Business School, United Kingdom.
• Kristin Berkinsky, Chief Human Resources Officer
Kristin Berkinsky has more than 20 years in global Human Resources experience across life sciences and pharmaceuticals, manufacturing, and business services. Kristin joined Adare from Conduent, Inc., where she served in a Global Vice President of Human Resources position. Kristin led talent and organizational initiatives for several business units within Conduent and supported the senior leadership across the organization in human resources related activity. Previously, she served as CHRO at Argo Turboserve, a global manufacturing and supply chain services organization. Earlier, Kristin worked in the CDMO industry as Global Head of Human Resources for Piramal Healthcare and CHRO at Halo Pharmaceuticals.
Kristin earned her BA in Philosophy from Pennsylvania State University. • Audrey Butler, Vice President of Global Operational Excellence
Audrey Butler brings over 25 years of Quality experience to her position as Vice President, Global Operational Excellence. During her career, she’s held positions of increasing responsibility in pharmaceutical manufacturing, including leadership of Analytical Development (R&D), Quality Assurance, Operations, Quality Control, and Project Management.
Audrey has served in the Quality divisions of pharma companies such as Hikma Pharmaceuticals, West-Ward Pharmaceuticals, Boehringer Ingelheim Roxanne, and Ben Venue Laboratories, Inc
She has a BS in Chemistry from University of Mary Washington and a Masters in Chemistry from University of Maryland.
• Shawn Watson, Vice President of Global Quality
For more than two decades, Shawn Watson has led Quality teams for organizations that develop specialty medicines. Leveraging his ability to solve complex scientific problems in highly regulated environments, he’s served as the Head Of Quality at Pii (Pharmaceutics International, Inc), Vice President of Quality & Analytical R&D at Lupin Pharmaceuticals, Vice President of Compliance at Sigmapharm Laboratories, and Vice President of Quality at URL Pharma.
Shawn holds a Bachelor’s Degree in chemistry and biology from Heidelberg University, a Master’s Degree in analytical chemistry from Villanova University, and an MBA from Temple University.
Shawn is passionate about enabling health care professionals to help people live healthier lives. He is a lifelong learner of leadership, emotional intelligence, and the collaboration process.
Key Capabilities and Services:
Product Development Capabilities
- Analytical Services
- Oral solids ER, IR, DR, Multi-layer, Minitabs, Powder in bottles/Caps, Suspensions, and Long acting injectables
- Pediatric formulations for oral delivery
- Small scale non-GMP and GMP development capability
- Physical characterization
- Controlled substance handling of DEA Schedules I-V
- Clinical supplies testing
- Technology transfer
- Analytical Method Development and Validation
- Method transfer
- On-Site GMP Testing
- On-Site Stability & Storage
Commercial Manufacturing Capabilities:
- Granulation and Mixing
- Roller Compaction
- Fluid bed processing & drying
- Wurster Top Spray
- Oven drying
- Pan coating
- Blending (Bin and Static)
- Tablet Printing & Inspection
- Capsule filling
- Small-scale GMP manufacturing
- Tech Transfer
- Warehousing & distribution
- Microencapsulation of solids and liquids
- Orally disintegrating tablets (ODT)
- Dry syrup/ suspensions
- MMTS™ Minitabs
- DEA Controlled substances:
- Manufacturing: classes II-V - Analytical Labs: classes I–V
- Fixed-dose combination manufacturing
- Liquid filling in hard-shell capsules with banding
- Solvent granulation and coating processes
- Food sprinkle dosage forms
- High Potency: 1 mcg/m3 and above
- High-speed bottle filling
- Low count - High count - Short run
- Blister packaging
- Thermo and Cold Forming
- Serialization competent
- Aggregation capable
- Specialty Packaging
- Clinical supply services - Stick pack and cartoning - Powder-in-bottle filling
Adare’s Specialized Technologies
Adare’s industry-leading experts possess unparalleled experience in the development of unique patient-centric dosage forms that provide taste masking, controlled release, and solubility enhancement capabilities. Our technology platforms address complex formulation challenges to deliver solutions that address the special needs of large patient populations like pediatric, geriatric, and dysphagic patients.
Parvulet® technology is a patient-centric dosage solution that enables a solid powder or tablet to convert to a semi-solid in the presence of water within thirty seconds. The final dosage is easily administered, as a soft food like texture, ideal for pediatric and geriatric populations (including those with dysphagia).
AdvaTab® Orally Disintegrating Tablets (ODTs) incorporates coated or uncoated drug particles that are uniformly dispersed in a low-moisture, rapidly disintegrating matrix. Each ODT is formulated to achieve an acceptable taste and desired release profile. AdvaTab® technology is ideal for patients who have difficulty swallowing, pediatric, geriatric, and dysphagic patients. This technology can be combined with Microcaps® and Diffucaps® to create Immediate release or controlled release ODTs.
Diffucaps® Customized Release Technology with the flexibility to incorporate functional, release-controlling polymers or protective coatings onto drug-layered cores, granules, or crystals. This allows for easy adjustment of both the dosage strength and dissolution profile to achieve the desired in vivo pharmacokinetic profile. Beads can have different release profiles, different active ingredients, or both—all in one product.
Microcaps® Taste Masking and Modified Release Technology that achieves uniform and efficient coating of drug particles by coacervation (phase separation) to build polymeric membranes of varying porosity and thickness. The result is a free-flowing powder containing microencapsulated API (or API substrate) in a wide range of particle sizes. The Microcaps technology can be applied to multiple dosage forms for both immediate and modified-release profiles
MMTSTM Multi Mini Tablet System Customized Release technology combines the simplicity of a tablet formulation with the flexibility of multiparticulate dosage forms with high drug-loading capability. Adare has developed Ultra Microtablets—a smaller standard of tablets targeting diameters in the range of 1.2 mm to even 1.0 mm. The small size facilitates the development of products that can offer multiple drugs or varying release profiles within a single capsule.
DIFFUTAB® technology is an effective solution for targeted drug delivery through customized and sustained release. The technology assists the development of high-dosage and sustained release products for once-daily administration. A matrix tablet is coated with functional polymers, followed by a blend of hydrophilic and hydrophobic polymers. Layered erosion and diffusion of the drug matrix tablet result in a controllable release.
Precision Particle Fabrication™ technology produces uniform microspheres and microcapsules with narrow size distribution and precise control over particle structure. The platform technology is flexible and customizable to accommodate a broad range of active ingredients, including small molecules, peptides, and proteins. The technology uses two physical processes simultaneously to create uniform droplets piezoelectric vibration and a co-flowing non-solvent “carrier” stream. For any given mass flow rate, droplet size can be reduced simply by increasing the frequency of vibration. The technology includes three platforms: Optimμm®, for oral delivery; StratμmTM, for injectable delivery; and Unisun®, for otic delivery.
Optimµm® technology creates microspheres with high drug loading suitable for taste masking, enteric coatings, and extended-release oral applications. The technology is capable of producing single- or double-layer particles in a one manufacturing step, lending to cost-effective creation of palatable dosage forms, which mimic traditional tablets, pills, and capsules. The Optimµm® technology allows for unprecedented control in release rate and dosage form properties. This technology is ideal for oral small molecules, nutraceuticals, agricultural applications, flavorings, and heat stable molecules.
StratµmTM technology, for injectable delivery, allows for precise control of particle size and composition enabling predictable injectable performance, which is critical for self-administration, extended release, and modified release applications with a narrow therapeutic index. Unlike other encapsulation techniques, Stratμm® is capable of producing single- or double-layer particles in a one manufacturing step, lending to creation of next-generation “pulsatile” release formulations or extended-release formulations. This technology is ideal for injectable small molecules, proteins, peptides, vaccines, and heat-labile molecules and requires lyophilization.
Unisun® technology combines the use of encapsulated or free drug, along with a fast-film forming agent, which allows for low-cost, long-acting intratympanic delivery of a therapeutic. The technology allows for less frequent administrations than current therapies and is capable of sustaining drug levels in the inner ear cochlea for weeks. The technology can be used inject and set up highly concentrated depots of a drug and is ideal for small molecules, proteins, peptides, and vaccines.
Adaptdose™, Adare’s unique commercialized approach to adaptive formulation design, is a highly flexible, multi-delivery platform tool that eliminates the need for post Phase 1 trial reformulations and facilitates the creation of custom oral delivery systems. Adaptdose provides the ability to combine 2-3 active ingredients or 3-4 delivery rates in a single capsule using minitablets, granules, and liquid.
Duragran™ allows for more uniformity and precise control of targeted particle sizes while providing production time and cost savings. It eliminates the need for extrusion and spheronization for high API-loaded drug particulates by using fluid bed processing technology that combines the particle sizing and coating processes. This creates controlled-release beads/granules of uniform and narrow particle size range.