For the past 20 years, MedPharm has been helping clients navigate the complexities of topical and transdermal drug delivery. In fact, MedPharm was the first company to achieve European approval of topical generic products with in vitro bioequivalence testing only. MedPharm has established a strong worldwide reputation as product development experts in topical and transdermal delivery routes including the skin, nail, eye, airway and mucosal membrane. With more than 20 years of formulation and manufacturing experience, the company has contributed to the development and approval of 55 marketed products for clients around the world, including the U.S., Europe and Japan. From its roots at King’s College London, the company has grown into a thriving organization, with fully established Centers of Excellence in Guildford, UK and Durham, North Carolina, employing more than 100 people.

Contract Pharma recently spoke with MedPharm’s Vice President of Business Development, Lynn Allen, about trends in topical and transdermal space, and the company’s expansion plans.
 
Contract Pharma: What makes Medpharm unique as a topical and transdermal drug development and manufacturing partner?

Lynn Allen: MedPharm combines rigorous formulation development with innovative performance testing to develop robust pharmaceutical products. Our philosophy includes a thorough understanding of solubility and excipient compatibility, developing it right from the start to save time and money throughout the development timeline. For early-stage development, we provide data that can advise investment decisions, compound selection or clinical trial design. Our bioequivalence testing services support generic companies with submission data. With highly automated processes and proprietary technology throughout the development cycle, we are changing the way our industry looks at topical formulation development.
 
CP: How would you describe the current state of the market for topical and transdermal pharma products?

LA: The global dermatology market remains a strong segment in the pharmaceutical space. The topical market continues to innovate with nearly 700 new products actively being developed in dermatology. Small molecule topical development remains a key segment while a growing area of focus for topical development has expanded to biologics.  
 
CP: What are the key trends driving the market? How do you see the market evolving in the years ahead?

LA: We continue to see growth in niche areas of the topical market. Delivery routes including ophthalmic and intranasal continue to be an area of focus. The ophthalmic market can be challenging for topical applications and we find performance modeling can help inform formulation decisions.  Inflammatory dermatosis continues to be an area of focus with an increasing interest in orphan diseases, acne, and rosacea. There is also a great deal of activity in drug development repurposing older drugs to improve performance while generating new IP.

 
CP: What are your customers main concerns/priorities?

LA: For early-stage companies, selecting the best compound and understanding the performance of that compound in the epithelia to which it will be applied is key to making the most informed investment and development decisions. We continue to innovate in this area by offering advanced performance testing to de-risk the formulation development process and offer data that supports informed decisions. 
 
CP: What technology advances are being made on the topical and transdermal drug delivery front?

LA: The approval of several key biologics has provided a better understanding of more complex and overlapping biological pathways. This is leading to a surge of small molecules in the topical space and many are advancing into clinical trials with some very close to approval. Advancements in tissue culture combined with a better understanding of inflammatory pathways have led to well characterized pharmacological models in skin explants. At MedPharm, the creation of fully automated testing systems (MedFlux and MedStat) to test formulations in epithelia used during the development of topicals have led to a better understanding of thermodynamic activity and pharmacokinetics of topical formulations.
 
CP: What are some of Medpharm’s business highlights over the past 12 months?

LA: MedPharm continues to invest in our systems, facilities and innovate models to offer the most advanced topical and transdermal development to our clients. We tripled our Durham, NC labs one year ago to support demand for our performance testing services and provide formulation services in the U.S.  We are refurbishing our UK site this summer, expanding our laboratory space to meet the growing demands of formulation development services. Our new Durham manufacturing site will expand our manufacturing services with clinical through small scale commercial GMP manufacturing in the U.S.
 
CP: Please provide some details on the new facility. How are plans progressing? When will it be completed?

LA: We are really excited about the new Durham manufacturing site. The plant was designed with state of the art controls and equipment that meet or exceed all GMP standards for semi-solid and liquid production in the U.S and EU.  The site will compound, fill, package and test semi-solid and liquid products. We will be operational Q2 2021 and look forward to welcoming clients to visit the new site. 
 
CP: What are some of the facility’s standout features?

LA: The site has compounding vessels with clean-in-place technology capable of filling creams, gels, ointments and solutions. We have flexible filling lines that support conventional packaging such as tubes, bottles and jars and unique packaging such as metered dose pumps and bag-on-valve packaging.
 
CP: How will the new facility expand and strengthen Medpharm’s capacity and capabilities as a drug development and manufacturing partner?

LA: We are excited to offer expanded services that allow topical and transdermal companies to continue with MedPharm further into the development cycle.  It will save development time and money and will allow MedPharm to continue to offer project support into commercial production. CP
 

MedPharm Expands UK Formulation Development Labs 

MedPharm Ltd. recently announced a £1.5 million refurbishment that will increase laboratory space in Surrey, UK by 30%.

The renovations will incorporate increased investment in automated technologies to maintain MedPharm’s leading edge in the pharmaceutical formulation development and testing sectors for topical and transdermal products.

Scheduled to be completed August 2021, the increased capacity will allow MedPharm to continue meeting the demand for its topical and transdermal services.
According to Dr. Rob Turner, General Manager UK, MedPharm, Expanding and reimagining the laboratory space will enable a streamlined workflow, allowing MedPharm’s scientists to provide optimal service to all of its clients for years to come. 

“We are excited to be renovating both our laboratory and office facilities to ensure our resources remain state of the art. MedPharm has been supporting clients from Guildford for 15 years and this renovation will secure our footprint here in Surrey for years to come,” said Dr. Turner.