Pharmaceutical Technology

NOVEMBER 21, 2022

The clinical hold placed by Instil Bio on DELTA-1 means that Instil Bio will have to re-evaluate its manufacturing process and will lose precious clinical development time on its way to a biologics license application (BLA).

FDA 59

FDA 59

European Pharmaceutical Review

DECEMBER 26, 2023

Having proprietary cell lines in house can also speed up USP by reducing the need to outsource and the time required to grow the cells before use. Achieving cost optimisation requires identifying opportunities for process simplification, improving productivity and optimising resources.

Packaging 87

Packaging Vaccines 87

PharmaShots

APRIL 13, 2023

The idea was coined by the ISPE to integrate discrete aspects like resources, organization & processes, culture, and information systems. Some of the significant transformations carried out to bolster biopharma industries are: Adapting to Pharma 4.0 Model: Inspired by the industry 4.0 model, the pharma 4.0

Vaccines 40

Vaccines Pharmaceutical Companies Pharmaceutical Companies Labelling 40

ISPE

SEPTEMBER 11, 2023

It also may not be available at all contract manufacturing organizations (CMOs), especially for biologic drug substances; thus, outsourcing may not be an option. The ISPE Good Practice Guide: Technology Transfer (Third Edition) advocates for balance between risk management, resource management, and regulatory expectations.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52