Overview

Overview

about Oakwood Labs

Our Commitment to Innovation and Quality

Since our founding in 1997, Oakwood Laboratories has been driven by a single purpose — to advance global healthcare through the development of innovative sustained-release injectable therapies. Leveraging our proprietary Chroniject™ technology platform, we design and manufacture pharmaceutical products that deliver enhanced therapeutic benefits, improving both treatment effectiveness and patient quality of life across a broad range of disease states and therapeutic areas.

Our commitment extends beyond scientific innovation. At Oakwood, we uphold the highest standards of quality, safety, and regulatory compliance in every project we undertake. From early-stage formulation through commercial manufacturing, each process is guided by rigorous cGMP practices and our culture of continuous improvement.

Collaboration is at the heart of our success. Over more than two decades, Oakwood has built and sustained strategic alliances with global partners, including pharmaceutical companies, research organizations, and material suppliers. These partnerships enable us to accelerate product development, expand access to new technologies, and bring impactful therapies to markets around the world.

Through this combination of technical expertise, proven quality systems, and collaborative spirit, Oakwood Laboratories continues to be a trusted partner to the pharmaceutical industry — dedicated to delivering safe, effective, and long-acting injectable solutions that meet the evolving needs of patients and healthcare providers worldwide.

Who We Are

Advancing Drug Delivery Through Innovation and Expertise

Oakwood Labs is a specialty pharmaceutical company dedicated to the development and manufacture of sustained-release injectable formulations. Our proprietary Chroniject™ polymer microsphere-based drug delivery technology platform enables the controlled release of active pharmaceutical ingredients over extended periods—improving therapeutic effectiveness, patient compliance, and overall treatment outcomes.

At the heart of our operations is a fully equipped and staffed research and development facility, complemented by an FDA-approved aseptic cGMP manufacturing site. This facility was specifically designed for the production of both clinical and commercial materials for long-acting injectable products. Our integrated approach—spanning concept development, formulation, scale-up, and commercial manufacturing—allows Oakwood to efficiently advance products from idea to market.

Oakwood has successfully collaborated on a diverse portfolio of partnered and internal development programs, covering a wide range of therapeutic areas and drug classes. Several of these programs, built on the Chroniject™ platform, have advanced through global Phase III clinical trials, underscoring the technology’s robustness and reliability.

In addition to our role as a Contract Development and Manufacturing Organization (CDMO) specializing in microsphere-based formulations, Oakwood also provides Contract Manufacturing (CMO) services for standard sterile injectable products. Leveraging our cGMP capabilities, we currently manufacture five commercial injectable products for external partners—delivering quality, consistency, and regulatory compliance at every stage.

Through scientific innovation, advanced technology, and an unwavering commitment to excellence, Oakwood Labs continues to be a trusted partner in bringing long-acting injectable therapies to patients worldwide.

Our Technology

Innovating Long-Acting Drug Delivery with Chroniject™

At the core of Oakwood Labs’ expertise is Chroniject™, our proprietary microsphere-based sustained release technology platform. This platform enables the controlled delivery of injectable therapeutics over extended durations—ranging from one week to one year—through precise formulation of biodegradable polymer microspheres. These microspheres encapsulate active pharmaceutical ingredients and release them at a predetermined rate, ensuring steady therapeutic levels while minimizing dosing frequency.

The Chroniject™ platform is uniquely versatile, offering broad compatibility with a wide range of molecule types, including small molecules, peptides, and proteins. This adaptability allows Oakwood to design and optimize formulations for numerous therapeutic areas, such as central nervous system (CNS) disorders, ophthalmology, oncology, osteoarthritis, and animal health, among others.

With over 25+ years of experience in polymer-based sustained release technology, Oakwood Labs has developed deep scientific understanding of the critical formulation and process parameters that define microsphere performance. Our R&D teams apply this knowledge to fine-tune key characteristics such as release kinetics, particle size distribution, polymer composition, and drug loading, enabling us to tailor each product’s release profile to meet specific clinical requirements.

Oakwood’s success is also driven by a network of developed strategic global partnerships that strengthen our capabilities across the development and manufacturing process. These collaborations include trusted relationships with polymer and raw material suppliers, regulatory consultants, and contract research organizations—ensuring consistent quality, scalability, and regulatory compliance at every stage of development.

Through this combination of proprietary technology, technical expertise, and collaborative innovation, Oakwood Labs has established itself as a recognized leader in the long-acting injectable (LAI) market. Our ongoing advancements in Chroniject™ technology continue to push the boundaries of sustained-release formulation science—delivering safer, more effective, and more convenient therapies for patients worldwide.

Our History

Building on a Legacy of Innovation in Injectable Pharmaceuticals

Oakwood Labs traces its roots back to Ben Venue Laboratories, once recognized as the largest independent injectable pharmaceutical manufacturer in the United States. Originally founded as a specialized division within Ben Venue, Oakwood Labs was established with a clear purpose — to pioneer the development of sustained-release injectable drug products that improve therapeutic outcomes and patient care.

The company was founded by Edward C. Smith and Mark T. Smith, both senior executives at Ben Venue Laboratories. Their leadership and vision played a key role in driving research and innovation during Ben Venue’s years of rapid growth. When Ben Venue was acquired by Boehringer Ingelheim in 1997, the Smiths saw an opportunity to continue their work independently. Prior to the sale, they successfully spun off Oakwood Labs as a standalone company, ensuring that its specialized research and development efforts could continue without interruption.

With headquarters and an R&D facility established in Oakwood Village, Ohio, the newly independent Oakwood Labs began building its reputation for scientific excellence and product innovation. To meet growing demand and expand its GMP manufacturing capabilities, the company opened a state-of-the-art manufacturing facility in Solon, Ohio in 2002.

From its beginnings as a small company to becoming a global recognized leader in sustained-release injectable technology, Oakwood Labs has maintained a steadfast commitment to advancing pharmaceutical science through innovation, quality, and integrity.