Dalton Pharma Services

Overview

Dalton Pharma Services is a leading pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Toronto, Canada. Since its formation in 1986, the company has provided integrated chemistry, drug development, and manufacturing services to pharmaceutical and biotechnology clients globally. The organization is Health Canada–approved and FDA-inspected, with over 35 years of experience emphasizing quality, speed, and flexibility.

Core Capabilities

Discovery & Development:

• Medicinal chemistry and contract research
• Polymorphic screening and synthetic feasibility analysis
• Synthetic route development and process optimization
• Conjugation services and scale-up of difficult chemistry
• Analytical development (accelerated stability testing, ICP-MS, UPLC, extractables & leachables)
• Drug analogue development

Manufacturing:

• cGMP API manufacturing and sterile API manufacturing
• API process development and reaction optimization
• Formulation development (including liposomal formulations and sterile formulations)
• Custom chemical synthesis in multi-kilo batches (22 L to 250 L glass reactors)
• Flow chemistry and hydrogenation capabilities
• cGMP oligonucleotide fill services

Fill-Finish Services:

• cGMP aseptic filling (liquid and powder)
• Sterile vial filling (including automated Capmatic Patriot® system and RoboFil™ aseptic powder fill-finish)
• Prefilled syringe and cartridge filling
• Isolator-based aseptic technology

Facilities & Infrastructure

The Toronto facility underwent significant upgrade and expansion in 2016, featuring:

• Approximately 2,500 sq ft (232 sq m) cGMP manufacturing area with Grade C classification
• Two GMP suites equipped with stainless steel tables, 8-foot walk-in hoods, and 6-foot bench-top fume hoods
• Aseptic filling area (~300 sq ft) with Grade A localized environment under Restricted Access Barrier Systems (RABs)
• New HEPA systems, vial washing-depyrogenation capabilities, and WFI system (Steris, qualified 2014)
• Autoclave room with Class A environment
• Two synthetic laboratories (~1,100 sq ft each) for R&D
• Hydrogenation room with 2 × 2 L Parr reactors
• Building Automation System monitoring temperature, humidity, and pressurization
• Security system with proximity card access and surveillance cameras

Regulatory & Recognition

• Health Canada Establishment License holder
• FDA-inspected facility
• CMO Leadership Awards (2016, 2017, 2018) from Life Science Leader in Quality, Reliability, Capabilities, Expertise, Compatibility, and Development
• Cannabis Analytical Test Licence from Health Canada (under Cannabis Act and Regulations)

Business Model

Privately held and self-funded. The company operates as a full-service CDMO with integrated capabilities allowing clients to accelerate drug discovery and development programs by consolidating process development, API manufacturing, and finished-dose manufacturing at a single location.