ISPE

MARCH 6, 2023

The vast majority of those in the pharmaceutical industry have shared partial decarbonization plans, but do not yet have concrete plans to achieve these decarbonization goals in the next 10–15 years, often citing a highly regulated environment as a hurdle. Finalized 9 August 2021. 1 Intergovernmental Panel on Climate Change (IPCC).

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ISPE

AUGUST 29, 2022

Regulatory submission and evaluation of chemistry, manufacturing, and controls (CMC) data may be required for changes that have a higher risk to impact product quality. The timing and data requirements vary depending on the reporting category, submission, and legal obligations in each individual jurisdiction.

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ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 10:14. Cell and gene therapies are part of advanced therapy medicinal products (ATMPs) and offer great potential for regenerative medicine, including ways to treat and cure a variety of acquired and inherited diseases. This article discusses types of facilities and design considerations for C>.

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