Sterling Pharma Solutions

Partnership development and manufacturing organisation (PDMO) services providing small molecule API development, bioconjugation solutions for antibody drug conjugates, and comprehensive pharmaceutical contract development and manufacturing lifecycle support from grams to tons.

Full-service API development, scale up and cGMP contract manufacturing services from grams to tonnes, spanning the full molecule lifecycle.

Flexible standalone and integrated ADC clinical and preclinical manufacturing services including cGMP clinical and preclinical manufacture of antibody drug conjugates and bioconjugates.

Specialised knowledge, dedicated equipment and purpose-built facilities to handle hazardous chemistries and controlled substances.

Specialist bioconjugation and ADC development services spanning from early discovery proof of concept through process development and scale up.

Comprehensive peptide development, manufacturing, purification, and analytical services supporting preclinical, clinical, and commercial peptide therapeutics.

Delivers specialist antibody drug conjugate (ADC) development services with specific containment capabilities for handling potent cytotoxins.

Specialised high potency labs for process development and manufacture of linker payloads supporting ADC development from early preclinical to GMP clinical and commercial manufacture.

Offers API development and manufacturing services with specialist expertise in peptide manufacturing and large scale chromatography.

Solid phase and agitated vessels for peptide coupling and synthesis at the Cork facility.

Chemistry development and scale-up services supporting technical requirements from development through to commercialisation.

An industry-leading outsourcing model that leverages a global network of sites to provide flexible access to scientific expertise, specialized disciplines, and drug development services.

Comprehensive drug substance production capabilities from 250L to 10,000L GMP manufacture.

Comprehensive solid state science and crystallisation development services supporting drug substance development programs and optimizing API solid forms.

Scale-up services to transition bioconjugation processes from laboratory to clinical manufacturing.

Manufacturing capabilities for highly potent APIs utilizing specialized reactor trains and cleanroom suites.

Robust analytical services and quality control offerings tailored to the unique realities of bioconjugation, supporting ADC discovery, development and clinical manufacturing.

Customized process development services for bioconjugation and linker payloads.

Biocatalysis development and manufacturing services utilizing natural and engineered enzymes for complex API development, high-throughput enzyme screening, reaction optimisation, and cGMP scale-up up to multi-tonnes.

Comprehensive controlled substance services supported by robust analytical expertise.

Provides a wide range of API cGMP and non-cGMP manufacturing services from pilot plant and kilo labs to full-scale commercial manufacturing, specializing in hazardous chemistry.

Manufacturing services focused on improving efficiencies, cost optimisation, supply chain resilience, and regulatory support as a pharmaceutical API matures towards patent expiry.

Extensive research and development expertise to support early phase small molecule projects, including custom synthesis, route scouting, process optimisation, and non-GMP supply for toxicology studies.

Extensive early phase expertise to successfully support preclinical and early clinical stages.

Method development and analytical testing to support drug substance and bioconjugate manufacture.

Continuous flow chemistry process development and manufacturing services for pharmaceutical API programs, supporting safety, cost reduction, and process control.

Comprehensive chemistry services supporting early phase small molecule projects, including custom synthesis, route scouting, process optimisation, and non-GMP supply.

Tailored analytical chemistry services to ensure ongoing quality, purity and efficacy.

Comprehensive controlled substance services supported by robust analytical expertise, stringent security controls, cGMP manufacturing capabilities, and regulatory certifications.

Early-stage proof of concept services for ADC and bioconjugation projects.

Specialises in delivering chemistry solutions for preclinical and early phase clinical trial material, catering for volumes from millilitres to 200 litre batches.

Specialized milling and micronisation services to support complex molecule project requirements.

Analytical testing and mass spectrometry services to support bioconjugation development.

Comprehensive drug discovery services to increase your chance of success from the start.

From pre-clinical CMC strategies to regulatory filings and post launch process improvement efforts.

Specialised chemistry services utilising diazomethane safely for complex API synthesis.

Synthesis of novel metabolites scaled up to multiple grams, designed with numerous stable isotopes including deuterium, carbon-13, nitrogen-15, oxygen-16, and oxygen-17.

Designing focused libraries for hit to lead and lead optimisation leveraging structure-activity data, computational modeling data, and medicinal chemistry experience.

Delivers comprehensive chemistry services to support programs in early drug discovery and development stages.

Delivery of solid state services, tools, and technologies needed to support development.

Impact mills, cone mills and jet mills to meet various particle size specifications.

Strategic and iterative hit to lead approach involving high-throughput screening, structure-activity relationship (SAR) analysis, and pharmacological property evaluation.

Pairing knowledge of structure with predictive modeling and functional assays to guide additional modifications and select the best candidate to progress forward.

Chiral synthesis services ranging from classic chiral synthesis to kinetic resolution technology applications.

Synthesising an extensive set of compounds to screen for possible hits and characterising each selected compound using methods like HPLC and NMR spectroscopy.

Synthesising and characterising relevant, widely available compounds to use as reference points throughout the drug discovery process.