Alchem Laboratories Corp.
Alchem Laboratories Corporation is dedicated to excellence in custom synthesis, process development, and manufacturing of fine organic chemicals and drug substances. They serve pharmaceutical companies, government programs, and clinical trials, providing services from synthesis and analytical development to cGMP manufacturing. Their mission is to be a value-creating partner in drug development, offering innovative solutions, rapid project implementation, and comprehensive support across all stages of drug discovery and production.
Industries
Nr. of Employees
small (1-50)
Alchem Laboratories Corp.
Services
Custom synthesis services
Design and execution of bespoke small-molecule syntheses and analog libraries, from route design through kilogram-scale production.
Process development and scale-up
Optimization and scale-up of chemical processes to pilot and kilogram scale, including process optimization and documentation.
cGMP API and drug product manufacturing
Clinical and pilot-scale cGMP manufacture of APIs and finished dosage forms (topical, oral, injectable), including filling, labeling and packing.
Formulation development
Formulation design and optimization for topical, oral, and injectable products to support preclinical and clinical studies.
Analytical method development and validation
Development, transfer and validation of analytical assays for process monitoring, impurity profiling, and product release.
Stability testing and QC release
Stability study execution and QC release testing for APIs, intermediates and finished drug products.
Custom synthesis services
Design and execution of bespoke small-molecule syntheses and analog libraries, from route design through kilogram-scale production.
Process development and scale-up
Optimization and scale-up of chemical processes to pilot and kilogram scale, including process optimization and documentation.
cGMP API and drug product manufacturing
Clinical and pilot-scale cGMP manufacture of APIs and finished dosage forms (topical, oral, injectable), including filling, labeling and packing.
Formulation development
Formulation design and optimization for topical, oral, and injectable products to support preclinical and clinical studies.
Analytical method development and validation
Development, transfer and validation of analytical assays for process monitoring, impurity profiling, and product release.
Stability testing and QC release
Stability study execution and QC release testing for APIs, intermediates and finished drug products.
Expertise Areas
- Custom organic synthesis
- Process development and scale-up
- cGMP manufacturing and clinical supply
- Formulation development for multiple dosage forms
Key Technologies
- Nuclear magnetic resonance (NMR)
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Liquid chromatography–mass spectrometry (LC-MS / HRMS)