ENCO expands EBPT’s ophthalmic and medical device capabilities

Rick Camp, President, Eurofins BioPharma Product Testing ENCO, Inc.

What an exciting time to be in the bio/pharma field! Eurofins BioPharma Product Testing (Eurofins BPT) acquired ENCO Pharmaceutical Development in the fall of 2022 after more than two decades of operation as an independent contract service provider. The acquisition expanded Eurofins BPT’s presence in the southeast United States and brought a significant amount of experience in three key areas: ophthalmic, medical device and animal health. Now renamed as Eurofins BioPharma Product Testing ENCO, we stand ready to serve in an even greater capacity, with expanded service offerings at both the former ENCO sites as well as connecting with added services throughout the Eurofins BPT network.

One of the areas where Eurofins BPT ENCO has considerable experience is in Ophthalmic Product Development and Testing. Ophthalmic products are a critical part of the healthcare industry, and ensuring their safety and efficacy is of utmost importance. Overall, ophthalmic drugs have been increasing in complexity due to advancements in our understanding of eye diseases, the need for specialized therapies for complex eye conditions, the use of combination therapies, the development of advanced drug delivery technologies, and the evolving regulatory landscape. Another factor contributing to the rapid growth in this area is age-related eye health, which will only continue to increase as our population ages. These factors have contributed to the development of more complex ophthalmic drugs to meet the growing demands of eye care and improve patient outcomes.

Eurofins BPT ENCO has a proven record of supplying reliable and accurate testing services for ophthalmic products, including solutions, ointments, lyophilized powders, and related ophthalmic devices such as contact and intraocular lenses. With decades of experience in ophthalmic drug delivery, we can also provide formulation development and optimization services, collaborating with our customers to supply an optimal finished product. Recently added services include the manufacture and supply of toxicological materials for use in GLP studies as well as early phase clinical trial materials.

Our ophthalmic services include a range of capabilities including analytical characterization and stability storage, assay, related substances, extractable and leachable characterizations of ophthalmic devices. Other Eurofins BPT sites provide microbiological tests such as sterility, preservative efficacy testing, and endotoxin testing. Our experienced scientists are trained in the industry standards for ophthalmic product testing as well as current regulatory requirements.

Medical Device Testing is also an area where Eurofins BPT ENCO has an established service history. In FDA terms, a medical device is an instrument, apparatus, machine, implant, or other similar article that is used in the diagnosis, treatment, or prevention of disease or other medical conditions. The FDA requires that medical devices meet specific requirements for safety, effectiveness, and quality before they are marketed in the United States. The level of regulatory control and the specific requirements for each device depend on the device’s classification and intended use. Where medical devices deliver a drug, they are often regulated as a ‘combination device,’ and depending upon the primary mechanism of action, will be regulated under either the FDA’s drug (Center for Drug Evaluation and Research, or CDER) or device (Center for Devices and Radiological Health, or CDRH) arms. Depending upon the device’s (or combination device) complexity, testing and characterization, requirements can become significant. Our experience in working with auto-injectors, stents, shunts, and lenses, including combination use where these devices are used to deliver drugs is a benefit to our customers in helping to streamline and simplify the development pathway. A recent example is the FDA’s action related to ophthalmic dropper bottles. Historically, bottles have been viewed as a primary container to hold the solution and exempt from medical device regulation. Recently (November 2022), the agency indicated that they may become regulated as medical devices, and therefore subject to increased regulation, including additional items as design history and quality systems registration of the device manufacturer. Eurofins BPT ENCO’s familiarity across the ophthalmic and device spaces enables us to quickly respond to requests and accommodate complex testing requirements.

Particularly within the United States, Animal Health has become a significant market, increasing from an estimated $18 billion in 2010 to more than $30 billion in 2020. For the numbers folks, the estimated annual growth rate for animal healthcare has outpaced human healthcare, increasing at an estimated 6.8% year on year, compared to approximately 4.3% for human health costs! The importance of preventive care, advances in veterinary medicine, and an increase in pet ownership all contribute to this growth. Eurofins BPT ENCO has provided services to the animal health market for well over a decade, servicing companion animals (cat, dog), equine and bovine markets.

Throughout all its services, Eurofins BPT ENCO places a strong emphasis on customer service and communication. The company collaborates closely with its clients to understand their specific testing requirements and supplies regular updates on the status of their testing projects, up to and including formal project management services. This level of transparency and collaboration has earned Eurofins BPT ENCO a reputation as a trusted partner in the ophthalmic testing industry.

In conclusion, Eurofins BioPharma Product Testing ENCO is a leading contract research organization that has experience in ophthalmic products, medical devices, and animal health testing. The company’s modern facilities and equipment, experienced staff, and commitment to customer service make it an ideal partner. Additional investment in facilities, capacity and capabilities under the Eurofins banner will allow us to continue to serve the ever-expanding needs of the biopharmaceutical market. Truly exciting times!