EXECUTIVE INTERVIEW – DPT Laboratories: Providing Solutions to Sterile & Non-Sterile Development & Manufacturing of Semi-Solid & Liquid Dosage Forms

DPT Laboratories, Ltd. is globally recognized as a leading contract development and manufacturing organization (CDMO) specializing in the sterile and non-sterile development and manufacturing of semi-solid and liquid dosage forms. DPT provides full-service solutions to pharmaceutical companies through innovation, advanced technology, scientific and technical expertise, and exceptional service. Recently, DPT launched a major expansion of its sterile capabilities and infrastructure. The company is widely known for its unmatched technical expertise, extensive manufacturing capabilities, and exemplary regulatory compliance record. Drug Development & Delivery recently interviewed Paul Johnson, DPT Group President and Chief Operating Officer, to discuss the consistent growth and success of DPT, its expansion in the sterile arena, and plans for the future.

Q: Can you briefly review DPT’s capabilities and services for our readers who may be unfamiliar with them?

A: DPT has a 75-year history of developing and manufacturing drugs for the pharmaceutical industry, with an unmatched record of regulatory compliance, financial strength, stability, and technical expertise in sterile and non-sterile semi-solids and liquids. With five cGMP facilities in San Antonio, TX and Lakewood, NJ, DPT offers full-service outsourcing solutions, including pharmaceutical development, site transfers, state-of-the-art pharmaceutical manufacturing, packaging, and distribution services.

We have three Centers of Excellence. Our Center of Excellence for Sterile and Specialty Products specializes in the development and aseptic manufacturing of clinical trial material and commercial-scale products to meet sterile requirements. This center features the newest aseptic manufacturing suites in the industry, a state-of-the-art microbiology lab, and advanced equipment, giving clients access to specialized capabilities. Aseptic manufacturing services include smallvolume parenterals, ophthalmic preparations, preservative-free nasal sprays, and sterile ointments. Supported by our seasoned experts and state-of-theart technology, we focus significant attention on regulatory compliance, which helps our clients avoid costly delays and achieve rapid time to market.

DPT’s Center of Excellence for Research and Development is a best-inclass facility that provides pharmaceutical development services, including preformulation and formulation development, analytical chemistry and quality control testing, and worldwide product distribution. The center performs R&D activities and supports technology transfers.

Our Center of Excellence for Semi- Solids and Liquids in San Antonio has more than 400 employees who provide cGMP pilot, clinical, and commercialscale manufacturing. As a CDMO, DPT gives customers the advantages of flexible batch sizes and having a central resource for process development, clinical trial materials, and full-scale commercial products without the added expense and time of site and technology transfers. The Center has a dedicated aerosol manufacturing facility, a raw material dispensing and distribution area, and a compounding and fill-and-finish area.

Q: DPT was recently acquired by Renaissance Acquisition Holdings, LLC. How will this affect DPT moving forward?

A: On July 5, we announced the acquisition of DPT by Renaissance, a portfolio company of RoundTable Healthcare Partners, an operatingoriented private equity firm focused exclusively on the healthcare industry. We believe the new business structure will have a very positive impact on the future growth and success of DPT. Renaissance and its management team bring a depth of industry experience, including a solid understanding of the contract manufacturing and development space, and a successful history of partnering with companies like ours to help them grow. This partnership provides the resources we need to accelerate our long-term strategic plans, which include maximizing our semisolid and liquid business in San Antonio, and achieving aggressive growth in our sterile and specialty products business in Lakewood.

DPT’s business is flourishing. Looking forward, DPT’s world-class management team, skilled scientists, and staff at our San Antonio headquarters will continue to advance our pattern of steady growth and leadership in the industry as we strive to meet our customers’changing needs for reliable, flexible services, expertise, and quality.

Q: What specialized services does DPT offer the industry?

A: DPT focuses on sterile and nonsterile semi-solid and liquid dosage forms – creams, lotions, gels, ointments, solutions, and suspensions. The development and manufacturing of these forms can be complex, requiring collaboration between experts managing each process. We have incorporated virtually every API, including biopharmaceuticals, into these platforms. We also offer full CMC documentation services for these products. Clients benefit by leveraging our experience early in the development process to avoid duplication in formulating their product.

Q: Can you expand upon DPT’s continued expansion of its sterile capabilities?

A: Our decision to expand our sterile services was based on our capabilities and experience in this area, a commitment to satisfy customer needs, and the growing market demand for sterile contract manufacturing services. We have substantial scientific, technical, and regulatory expertise in aseptic development and manufacturing of clinical trial and commercial-scale products that meet sterile requirements.

In the past 2 years, DPT has invested more than $40 million in the expansion and upgrade of our Sterile and Specialty Products Center of Excellence. Most recently, we are in the process of installing a Modular Aseptic Compact (MAC) System, the most advanced, integrated, fully automated filling line in the industry. The consolidated system enables fast, reliable filling with the least likelihood of introducing microbiological contamination. These upgrades expand our capacity and most importantly, increase our ability to better serve clients with high-speed, cost-effective manufacturing runs. Continued investment at this level represents our commitment to maintain our position as the leading provider of pharmaceutical development an manufacturing services for semi-solid and liquid products.

Q: What makes the company’s business model unique to its partners?

A: As a full-service, flexible CDMO, DPT offers three primary benefits. The first advantage is greater project efficiency and continuity through fewer development hand-offs. Having one partner through the entire process enables a smoother transition from development to launch, and decreased regulatory complexity. DPT is a onestop shop, providing comprehensive services across all facets of drug development, from concept and preformulation through clinical and commercial manufacturing. Our technical specialists and management in all areas are always available to clients.

Another key benefit of a CDMO is the flexibility this business model offers drug sponsors. DPT can become a major component of a client’s development and commercialization efforts, involved at various stages as technical experts, joint project overseers, hand-off specialists, advisors, and supply chain managers. As a partner, we become fully in tune with a client’s objectives and integrated with its internal processes. An alternative model is utilizing the CDMO at specific times as needed.

The greatest benefit comes from the multiple linkages of collaboration between the CDMO and client, and close collaboration between development and manufacturing. DPT’s R&D and manufacturing processes are physically integrated in our facilities to enhance the flow of product development, preparing a client’s drug candidate for a smooth pathway to commercialization. For the complex development processes required for semi-solids and liquids, close collaboration between development and manufacturing is essential.

Beyond the technical, regulatory, and specialty expertise of the CDMO is the sponsor benefit of significantly less investment in facilities and equipment, an improved flexibility in the use of financial resources. A strategic partnership with a CDMO can also offer a link to regulatory bodies and supply chain parties around the world. As new technologies emerge, requiring changes in processes, expertise, and infrastructure, a CDMO can quickly and efficiently accommodate sponsor needs, providing development, evaluation, prototyping, testing, counseling, and manufacturing.

The day of the fully converged pharma service provider – offering discovery and early stage development support, clinical trials, drug development, formulation, and manufacturing support – may well be in our future. But it’s not here yet. This is the time of the CDMO.

Q: Why should a company partner with DPT Laboratories?

A: DPT has a stellar regulatory compliance record, and a broad reputation for our significant expertise and success in sterile and non-sterile semi-solid and liquid dosage products. Our infrastructure, including vigilant attention to quality, substantial advanced facilities, R&D, and scientific and engineering expertise, enables us to manage multiple projects at the same time. With these substantial capabilities, sponsor companies gain significant efficiency, accuracy, and reliability on the pathway to product launch.

DPT also takes a proactive approach to extend product life cycles. We focus on new technologies and innovation to bring continued value to our clients, and strive to achieve operational excellence.

Q: What is the advantage of a strategic partnership arrangement between sponsor and service provider?

A: A strategic relationship forces the service provider and client to look at the relationship in a different paradigm, from tactically for a few as-needed interventions to a far more integrated, collaborative style with greater commitment, transparency, and involvement throughout all processes. The partnership enables greater efficiency, with both partners complementing each other’s capabilities. DPT has dedicated resources proactively working on multiple projects for our clients, so we are not working on an opportunity-by-opportunity basis. Also, access to scientists and senior management on both sides is more prevalent, and the information flow between partners is more consistent and frequent.

Q: What are the most common reasons companies choose to partner with DPT Laboratories?

A: Our extensive experience, our world-class experts, our technologies and capabilities, and outstanding, collaborative customer service. We understand our clients’ challenges and we’re here to help solve them. We can deliver more effective solutions for our partners more efficiently and help them achieve higher value results than anyone else in our specialty areas. And the earlier and more extensively we’re involved in a product’s development, the better the results are likely to be.

Q: What do you see as the key industry trends and issues that will impact the life science industry over the next 5 years, and what key messages do you want to convey to our readers?

A: The industry faces increased regulatory challenges and must invest more time and resources to ensure compliance. As a result, pharmaceutical companies are increasingly depending on their outsource partner to help them avoid costly regulatory delays and achieve speed to market. DPT excels in this area and continues to invest considerable financial resources in technology, infrastructure, and people to ensure that DPT’s commitment to quality and regulatory compliance is maintained in today’s changing environment.

With pharmaceutical companies increasingly depending on service providers, it is essential that they choose a reliable, highly competent partner. In addition to having outstanding technical expertise and needed capabilities, the CDMO must be able to execute services competently and efficiently, working flexibly as a team to achieve clients’ goals and solve challenges.

Another industry trend is the need for sponsors to launch differentiated products. DPT has assisted its business partners in achieving this objective by providing innovative formula and delivery systems, such as unit-dose intranasal and aerosol foams.

Q: How do you see DPT evolving in the future?

A: Moving forward, we will continue to add capabilities that complement what we do best, bringing our industryleading development and manufacturing competencies in sterile and non-sterile semi-solids and liquids to our pharmaceutical partners. DPT will continue to monitor market trends and intelligence, strive to understand the current and future challenges our clients face, and respond to their changing needs. Our vision is to continue focusing on our core business of semi-solids and liquids, emphasizing innovation, highquality service, and the best technology. We will also expand into adjacent technologies that will bring value to our clients. Our goal is to be the best at what we do, with success defined by customer satisfaction.