Dalton Pharma Services

Custom cGMP sterile API manufacturing services supporting drug discovery from preclinical to small scale commercial, including sterile filtration, dry heat sterilization, and powder/liquid sterile filling.

Accelerate development of your finished dosage form by integrating process development with your API and/or dose manufacturing programs.

Comprehensive analytical services supporting integrated services including drug discovery, drug development, process development, contract cGMP API synthesis, and cGMP finished dose manufacturing.

Comprehensive analytical laboratory services including analytical method development, optimization, validation, and accelerated stability studies.

A fully automatic sterile vial filling line that provides automated sterile filling, stoppering, crimping, capping, and serialization for pharmaceutical manufacturing.

Sterile cGMP manufacture of aseptically filled or terminally sterilized liquid parenteral vials for clinical or small scale commercial products.

An accelerated development program utilizing upgraded sterile cGMP manufacturing facilities to formulate and manufacture bulk clinical liquid vial batches from active pharmaceutical ingredients.

Comprehensive contract provider services including drug discovery, flow chemistry, formulation and process development, custom synthesis, cGMP sterile fill/finish, cGMP API manufacturing, and dosage form manufacturing.

Sterile vial filling and aseptic manufacturing services operating under cGMP requirements.

State-of-the-art cGMP manufacturing and aseptic filling facility in Toronto, Canada, offering comprehensive API manufacturing, sterile vial filling, and customized laboratory services.

End-to-end custom chemical synthesis services ranging from milligram discovery batches to multi-kilogram cGMP lots, supporting small-molecule drug development from idea to IND.

Custom synthesis and active pharmaceutical ingredient process development and manufacturing under cGMP guidelines.

Comprehensive cGMP aseptic filling services for oligonucleotides supporting pharmaceutical drug development through clinical trials and commercial production, featuring both aseptic liquid and powder filling into vials.

API process development and reaction optimization services.

Custom chemical synthesis and fine chemical services providing low volume, high value small molecules for biotechnology and pharmaceutical applications in vessels up to 300L in R&D and cGMP environments.

Comprehensive formulation development for drug candidates.

Integrated sterile product formulation development services ranging from simple sterile liquid formulations to complex liposomal or lyophilized formats.

Custom chemical synthesis services tailored to customer specifications.

Comprehensive analytical testing and stability testing services supporting drug development and manufacturing programs.

Expert medicinal chemistry services for lead generation and optimization.

Evaluation of potential chemical migration from packaging and container closure systems.

Exhaustive screening of polymorphic forms for any active pharmaceutical ingredient (API) using state of the art analysis including DSC, XRPD, FTIR and dissolution/solubility testing.

Development and validation of analytical methods for large or small molecules.

Synthetic feasibility, route development, process optimization, and scale-up services provided by expert synthetic organic chemists.

Custom liposomal formulation services utilizing synthetic and natural liposomes for small molecules, proteins, and peptides with aseptic or terminally sterilized manufacturing.

Validation services for manufacturing processes and equipment cleaning procedures.

Comprehensive stability services including protocol development, intermediate term stability, and long term stability programs supported by modern laboratories and qualified in-house stability chambers.

Specialized conjugation services for drug development programs.

Custom conjugation services offering customized design and synthesis solutions for the conjugation of small molecules with synthetic or natural polymers for drug delivery, targeted drug delivery, and diagnostic applications.

Expertise in structure elucidation of unknown synthetic impurities, intermediates, degradants, and excipient-related impurities with over 30 years of experience.

Release testing for raw materials and finished products, including cytotoxic materials.

HPLC and GC chiral analysis and preparative chiral chromatographic separations for diverse compounds.

Certification services for reference standards used in analytical testing.

Standard physical and wet chemical testing methods for characterization.

Elemental analysis using ICP-MS for raw materials and finished products.

Physical and chemical testing of packaging and container systems.

A dedicated project management service led by experienced GMP operations project managers to keep drug development programs on time and on budget.

Cost-effective, efficient, and safer approach to chemical synthesis with increased scalability and flexibility.

Ultra-Performance Liquid Chromatography (UPLC) analysis testing services offering efficient LC quantitative and high-throughput QC analysis, method development, and validation.

Bioburden analysis, environmental monitoring, water testing, bacterial endotoxin testing, and sterility assurance.

GMP/GLP Size Exclusion Chromatography - Multi Angle Light Scattering (SEC-MALS) analytical services for the absolute determination of molar mass of large molecules.

Catalogue of over 3000 fine chemicals including labelled compounds, metabolites, impurities, and natural compounds.