ABC microbio

• Supply chain and Optimization of purchasing processing • Design, validation and implementation of microbiology methods • Laboratory design, start-up and qualification • Design of daily lab operations • Investigations of microbial excursions, presence of objectionable organisms and out-of-specification findings • Laboratory optimization and management • Laboratory design, qualification, optimization and automation • Microbial identification strategies SOP and protocol development • Method validation and process technology transfer- Scale up and Scale down process • Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions) • Failure investigations and root cause analysis • Scale up and scale down microbial/fermentation process • Early-stage, mid and late stage process development design • Nonclinical CRO/CMO/CDMO selection and oversight support • Evaluate the existing synthetic route and identify the steps that may cause problems during scale-up manufacturing • Process improvement based on the concept of Quality by Design (QbD) • Search for reliable suppliers for key starting and raw materials • Design process optimization - Safe and robust processes • Process and DS cost optimization studies • Microbial strain selection and characterization, media development