PharmTech
6 days ago · A genetic medicines customer has selected the company’s binders for commercial development of the customer’s product. 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 ...
Deviation Investigation Format and Content: A Guide for
Jul 2, 2017 · History review. The history review section is intended to provide the reader with an overarching historical context of the deviation event. This section typically includes a query of the quality management system with specific words and phrases pertaining to the current deviation event with the goal of identifying similar and/or related events.
Understanding USP Water for Pharmaceutical Use - PharmTech
May 1, 2017 · Understanding USP Water for Pharmaceutical Use. The type of water for pharmaceutical use is determined by USP testing. Manufacturing of pharmaceutical products, medical devices, biologics, cell- and tissue-based products, and many other medical products requires significant volumes of water. Water is more complicated than what most people think.
Classifying Potent and Highly Potent Molecules - PharmTech
Aug 1, 2018 · This variability in classification is exemplified by a study carried out by Cambrex in which a panel of 38 molecules was sent to three risk assessors. Three different results were provided: one assessor deemed five of the 38 to be highly potent, one assessed 37 of the 38 to be highly potent, and the third fell somewhere between the two extremes.
Pharmaceutical Technology - PharmTech
The Real Message Behind Commercial mRNA Products, April 2023 eBook
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 ...
Understanding Dissolution Testing - PharmTech
Jun 2, 2017 · Dissolution testing provides crucial in-vitro drug release information that is routinely used for quality-control (QC) and quality-assurance (QA) purposes in the pharmaceutical industry. The quality-by-design (QbD) approach places strong emphasis on the role of dissolution testing in optimization of a formulation’s drug release rate and evaluation of critical process parameters …
Understanding the Impact of Annex 1 on Isolator Design
Nov 3, 2020 · The first draft of the European Union (EU) good manufacturing practice (GMP) Annex 1, “Manufacture of Sterile Medicinal Products” was published for comment on the December 20, 2017 (1) and generated great interest internationally, as it was the first adaptation to the full EU GMP document on the manufacture of sterile medicinal products since …
The Fundamentals of Dissolution Testing - PharmTech
Oct 2, 2019 · The Fundamentals of Dissolution Testing. Pharmaceutical Technology, Pharmaceutical Technology-10-02-2019, Volume 43, Issue 10. In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.