Sterling Pharma Solutions
Contract development and manufacturing organisation (CDMO) with five decades of experience in active pharmaceutical ingredient (API) development and manufacture. Operates a network of facilities across the UK, US and EU and provides integrated services from route design and process development through clinical supply and commercial cGMP manufacture. Technical strengths include hazardous chemistry and formal hazard evaluation, high- and ultra-high-potency API handling with multi-layered containment, continuous flow chemistry, biocatalysis, peptide synthesis and preparative chromatography, ADC bioconjugation, particle-size engineering, chiral chemistry and analytical method development. Maintains an on-site hazard evaluation team and laboratory with over 30 years of process-safety experience.
Industries
Nr. of Employees
Very Large (1000+)
Sterling Pharma Solutions
Cramlington, Northumberland, United Kingdom, Europe
Products
Small Molecule API Development
Development services for small molecule active pharmaceutical ingredients (APIs) tailored to pharmaceutical industry needs.
Small Molecule API Manufacturing
Manufacturing services for small molecule active pharmaceutical ingredients for pharmaceutical companies worldwide.
Small Molecule API Development
Development services for small molecule active pharmaceutical ingredients (APIs) tailored to pharmaceutical industry needs.
Small Molecule API Manufacturing
Manufacturing services for small molecule active pharmaceutical ingredients for pharmaceutical companies worldwide.
Services
API development and process development
Route scouting, medicinal and process chemistry, DOE-based process optimisation and support for preclinical-to-clinical transition.
cGMP API manufacturing
Clinical and commercial GMP manufacture of small-molecule APIs, including specialised chemistries, configurable containment for potent compounds and campaign manufacturing across global facilities.
Analytical services and method validation
Analytical method development and validation, impurity identification and characterisation, stability-indicating methods, forced degradation studies, PGI assessment aligned with ICH M7, and routine QC testing across the molecule lifecycle.
Controlled-substance development and manufacturing
End-to-end manufacturing support for scheduled substances including licensing support, secure storage and inventory systems, regulatory liaison, and documented waste disposal and chain-of-custody controls.
Hazardous chemistry and diazomethane process development
Specialist hazardous-chemistry services including hazard evaluation, specialised equipment and controlled diazomethane generation workflows for safe, scalable API reactions.
ADC development and clinical manufacturing
ADC bioconjugation services and cGMP clinical manufacturing with isolator-based operations, buffer preparation capacity, TFF and preparative chromatography to support conjugation and analytical workflows.
API development and process development
Route scouting, medicinal and process chemistry, DOE-based process optimisation and support for preclinical-to-clinical transition.
cGMP API manufacturing
Clinical and commercial GMP manufacture of small-molecule APIs, including specialised chemistries, configurable containment for potent compounds and campaign manufacturing across global facilities.
Analytical services and method validation
Analytical method development and validation, impurity identification and characterisation, stability-indicating methods, forced degradation studies, PGI assessment aligned with ICH M7, and routine QC testing across the molecule lifecycle.
Controlled-substance development and manufacturing
End-to-end manufacturing support for scheduled substances including licensing support, secure storage and inventory systems, regulatory liaison, and documented waste disposal and chain-of-custody controls.
Hazardous chemistry and diazomethane process development
Specialist hazardous-chemistry services including hazard evaluation, specialised equipment and controlled diazomethane generation workflows for safe, scalable API reactions.
ADC development and clinical manufacturing
ADC bioconjugation services and cGMP clinical manufacturing with isolator-based operations, buffer preparation capacity, TFF and preparative chromatography to support conjugation and analytical workflows.
Expertise Areas
- API development and manufacturing
- High-potency API containment and manufacture
- Controlled-substance handling and regulated logistics
- Hazardous chemistry and hazard evaluation
Key Technologies
- HPLC / UHPLC (DAD, ELSD, CAD, fluorescence detectors)
- GC and GC-MS
- LC-MS workflows for impurity and DAR analysis
- Multinuclear NMR (200–500 MHz)