impurity profiling

AIT/Qualytics is a customer-oriented analytical instrumentation and service provider specialized in cost-effective solutions for the NMR community, drawing on 40+ years of NMR experience. It provides instrumentation, servicing, support, sampling, and analysis in its NMR facility, which houses four fully-operational Bruker NMR systems. It serves pharmaceutical, biotech, and CRO industry customers with structural solutions, impurity profiles, and NMR experiments and data acquisition.

cryogen fillingexperiments and data acquisitioninstallation and maintenance of NMR equipmentNMR automation customizationNMR software setupNMR spectroscopyrepair servicesspectrometer relocationstructural elucidation

Apnar Pharma LP is a privately owned, rapidly growing pharmaceutical company engaged in the acquisition, licensing, development (ANDA), sales, manufacturing, marketing and distribution of generic pharmaceuticals, drugs, and OTC non-prescription items for the U.S. market. It is a NABP Verified-Accredited Wholesale Distributor (VAWD) compliant with Federal and State DSCSA rules.

analytical method developmentblister packagingbottle packagingdistributionformulation developmentmanufacturingpreformulation studiesquality assurancequality controlRegulatory Affairssecondary packagingvalidation services

Argonaut Manufacturing Services is a flexible fill-finish CDMO that fills a wide range of formats and drug types from preclinical through commercial scale. Its 90,000-square-foot manufacturing campus spans three facilities in Carlsbad, CA, and uses isolator-based filling lines with fully automated processes. The company supports programs with in-house analytical and QC services, cGMP storage, and partner services including API manufacturing and GMP packaging.

analytical testingaseptic processingcGMP storagecontainer closure integrity testingFill-finishisolator-based fillingmethod validation and transferrelease testingstability testingsterile filtration

Auspep is the only GMP accredited manufacturer of peptides in Australia and specialises in the development and production of synthetic peptides as active pharmaceutical ingredients (APIs). Its GMP facility is the only TGA registered peptide manufacturing plant in Australia, providing GMP services for clinical trials and large scale manufacturing, plus analytical and quality control services.

amino acid analysisanalytical chromatographycold chain managementcustom peptide synthesisGMP peptide manufacturingion content analysismass spectroscopy/LCMSNMR spectroscopyN-terminal protein sequencingpeptide purificationprotein carrier conjugationstability trialswater content testing