6533b855fe1ef96bd12aff1c

RESEARCH PRODUCT

In-use physicochemical and microbiological stability of biological parenteral products

Jonas FastMichael AdlerIrene KrämerWilliam J. GalushHanns-christian MahlerJamie MooreUlla GrauschopfMargaret Speed RicciUlrike AltenburgerAnkit R. PatelMichelle FrazierMary E.m. CromwellPierre Goldbach

subject

PharmacologyBiological ProductsBacteriabusiness.industryChemistry PharmaceuticalDrug CompoundingHealth PolicyProteinsBiotechnologyPharmaceutical SolutionsDrug StabilityHumansInfusions ParenteralBusinessBiochemical engineeringProduct (category theory)Drug ContaminationDrug PackagingBiotechnology industry

description

Pharmaceutical scientists in the biotechnology industry have traditionally focused on achieving acceptable shelf lives of drug products in their original, unopened product unit configuration (e.g., two years stored at 2–8 °C). However, it is now clear that stability considerations extend beyond

https://doi.org/10.2146/ajhp140098