PharmTech
2 days ago · Out-of-the-Box Packaging Advancements. Pharmaceutical packaging must advance to adapt to new, complex modalities. Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and …
The Basics of Aseptic Processing - PharmTech
Oct 2, 2021 · A. Aseptic processing is a manufacturing method that can produce product that is absent of bacteria without subjecting the product to terminal sterilization processes. Many products degrade and become ineffective when subjected to the harsh conditions of terminal sterilization. Aseptic process manufacturing allows these products to be produced ...
Best Practices for Designing and Building a Pharmaceutical ...
Feb 2, 2021 · Best Practices for Designing and Building a Pharmaceutical Manufacturing Facility. Pharmaceutical Technology, Pharmaceutical Technology-02-01-2021, Volume 2021 Supplement, Issue 1. For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial. To achieve delivery of a facility that ...
Pharmaceutical Technology - PharmTech
The Real Message Behind Commercial mRNA Products, April 2023 eBook
Understanding the Impact of Annex 1 on Isolator Design
Nov 3, 2020 · The most important points in the draft EU GMP Annex 1 with regard to isolators are illustrated in Figure 1. The starting point for every CCS is the risk observation of the design of the isolator system, including the installation of equipment in an isolator, such as a fill/finish machine for vials, syringes, etc.
PharmTech
Genentech Enters an Approximately $2 Billion Deal to License Sangamo Therapeutics Technologies for Developing Neurodegenerative Disease Therapeutics. August 20th 2024. Genentech will have access to Sangamo’s capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines for certain neurodegenerative diseases.
The ICH Q9 Revision and a Renewed Focus on Quality Risk
Dec 2, 2023 · The new revision of ICH Q9 states that “subjectivity can be introduced in quality risk management through differences in how risks are assessed and in how hazards, harms, and risks are perceived by different stakeholders” (1). This ‘bias’ that has been common across the application of QRM in the industry has been one of the hurdles to ...
Top News - PharmTech
Aug 22, 2024 · AbbVie Strengthens Neurological Pipeline with $8.7 Billion Acquisition of Cerevel Therapeutics. August 03, 2024. This acquisition gives AbbVie clinical-stage assets from Cerevel’s pipeline that complement AbbVie's emerging neuroscience pipeline and branded products for treating psychiatric disorders, migraine, and Parkinson's disease.
Scale-up and Tech Transfer: From Development Lab Studies to
Nov 3, 2022 · Scale-up and Tech Transfer: From Development Lab Studies to Commercial Production. Published on: November 3, 2022. Doris Rottenbusch. Pharmaceutical Technology,Pharmaceutical Technology, November 2022, Volume 46, Issue 11. Adherence to detail and thorough project management are required for successful tech transfer and scale up.
Implementing Process Analytical Technology - PharmTech
Mar 3, 2023 · Advances in process analytical technology (PAT) are enabling increased use of in-line PAT instruments for real-time measurement in continuous manufacturing (CM) of oral solid dosage (OSD) drugs. Broad use of PAT is crucial in development stages to build understanding of the product and process. In commercial manufacturing, manufacturer’s ...