Dalton Pharma Services

These include early-stage research and development for new drug prospects, creation of material used in clinical drug trials, and manufacture of commercial drug products. CDMOs enhance industry drug development efforts by accelerating the end-to-end development process while ensuring compliance with regulatory standards.

Dalton Pharma was founded in 1986 by CEO Peter Pekos and was part of the technology incubator program at York University in Toronto. By 1998, Dalton had grown to 20 employees and occupied more than half of the York incubator; expansion into a larger manufacturing space while remaining close to the university’s talent and resources was critical to fostering continued growth. In 2000, Dalton moved into a new 42,000 square foot facility in North York designed to accommodate future growth while being flexible to meet changing customer needs. Dalton was recently acquired by Tokyo based Seikagaku Corporation, a multinational pharmaceutical company, and this association will provide investment to fuel growth, and synergies that will extend Dalton’s international reach.

Listening to the changing needs of their customers has shaped the services offered by Dalton which currently include large-scale chemistry and research capabilities, finished dose sterile manufacturing, custom synthesis, cGMP API manufacturing, formulation and API process development, and accelerated stability services. Custom synthesis is critical to drug development as it involves the creation of molecules customized to client requirements. Formulation development is also a key service as it can lead to drug patentability which can extend the life cycle and profitability of a pharmaceutical product.

A critical aspect of Dalton’s success is ensuring strict compliance with all regulatory requirements. Health Canada is known to be among the world’s most stringent regulators, and pharmaceuticals manufactured in Canada are held in high regard across the globe. Dalton is also an FDA inspected facility, ensuring that quality controls meet strict U.S. regulatory standards for pharmaceutical manufacture. Dalton uses a variety of quality control equipment to maintain Good Manufacturing Practice (GMP) compliance, allowing the company to test and control manufactured products and materials. Specifications are set with a target profile in mind for all critical attributes of product quality and performance. Methods are also developed to meet International Council for Harmonization (ICH) requirements. The ICH brings together regulatory authorities and pharmaceutical companies to discuss the scientific aspects of product development and registration. Through all phases, clinical to commercial, risk assessments are built into each stage. This includes electronic linkages that facilitate real time assessments and adjustments. A robust internal training program ensures that quality control personnel are current with industry and regulatory standards.

Automation plays an important role in the company’s manufacturing processes. Processes including the automated filling of powders and liquids, particle monitoring for clean room areas, and analytical testing processes are all performed using automation. The system that monitors the clean room for nonviable particles produces data and includes a series of alarms and warnings monitored by microbiologists to continuously improve the environment. For testing, units contain calibrated robotic arms that can be programmed by analysts to queue sequences for different types of testing including high-performance liquid chromatography, gas chromatography, mass spectrometry, ion chromatography and total organic carbon.

Dalton’s recent acquisition of two Health Canada approved cannabis licenses allows for support of initiatives in the controlled substance marketplace. In a recent successful collaboration, Dalton partnered with Ontario-based Cardiol Therapeutics in the clinical and commercial development of cannabis related products for therapeutic use. Dalton has further supported Cardiol in the development and manufacture of Cortalex, an oral Cannabidiol, which is now commercially available at Shoppers Drug Mart.

Dalton is also playing a focal role in the battle against COVID-19 through it’s work in the manufacture and distribution of COVID-19 test kits. Dalton has been working to scale up and supply hundreds of thousands of viral transport medium tubes per week, which deactivates infectious agents. They are looking to further scale up to supply the needs of Canada and possibly other countries. As leaders in sterile manufacturing, a critical component in the development of vaccines, Dalton has also supported VIDO-Intervac at the University of Saskatchewan in the production of a Canadian COVID-19 vaccine.

Given the complexity of Dalton’s processes, recruitment, training and retention of knowledgeable and skilled employees is a key priority. Dalton credits its proximity to top universities as a key source of innovative talent, but also searches for qualified employees from around the world, and for many colleagues Dalton represents their first job in Canada. Dalton considers team diversity to be a key strength and nurtures this value by offering English language instruction and encouraging the expression of local cultures at various staff events throughout the year.

Dalton has received multiple industry awards over the years and for Pekos, his proudest achievement is being acknowledged for having a welcoming, collaborative, and diverse culture. Dalton has received the Great Place to Work designation every year since 2016 and was acknowledged as a Great Place to Work for Women in 2020. Dalton is proud that 42% of leadership roles are held by women. According to Pekos, “Dalton is not too big and not too small. We are at a size where we have the depth of talent and capability to handle multiple service areas with excellence. And we are small enough that we care about everybody.”

Looking to the future, there has never been greater opportunity for a collaborative, innovative, results oriented organization like Dalton. As experts in partnering with pharmaceutical companies to rapidly discover, develop, and manufacture life enhancing medicines and drugs, Dalton is helping to create a healthier world.