Development of a Continuous Flow Grignard Reaction to Manufacture a Key Intermediate of Ipatasertib
D Kaldre, S Stocker, D Linder, H Reymond… - … Process Research & …, 2023 - ACS Publications
This article outlines the development of a continuous flow process for the manufacture of a
key intermediate of the active pharmaceutical ingredient ipatasertib for the treatment of …
key intermediate of the active pharmaceutical ingredient ipatasertib for the treatment of …
QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters
PD Rege, A Schuster, J Lamerz… - … Process Research & …, 2024 - ACS Publications
The quality-by-design (QbD) approach is widely utilized for developing and validating
manufacturing processes for drug substances as well as drug products. This paper …
manufacturing processes for drug substances as well as drug products. This paper …
Risk Management of the Minimum CMC Regulatory Compliance Continuum
J Geigert - The Challenge of CMC Regulatory Compliance for …, 2023 - Springer
The challenge of control of the biopharmaceutical manufacturing process coupled with the
complexity of the resulting biopharmaceutical products create pressure on meeting the CMC …
complexity of the resulting biopharmaceutical products create pressure on meeting the CMC …
[PDF][PDF] An update on Roche's experience with the Impact Ratio, year six
J Lamerz, D Coleman - ncs-conference.org
An update on Roche's experience with the Impact Ratio, year six Page 1 1 21.10.2022 | NCS
Conference 2022, Louvain-la-Neuve, Belgium Jens Lamerz, Daniel Coleman An update on …
Conference 2022, Louvain-la-Neuve, Belgium Jens Lamerz, Daniel Coleman An update on …