Search results for "quality"
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
The goal is to provide high quality and sustainability,” he says. Removing manual operations and human error from the process will be crucial.
Invetech has been working on cell therapy process sca…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Other advantages of continuous manufacturing include consistent product quality; smaller equipment; streamlined processes; low process cycle times; reduced operating costs; increased flexibility; elim…
Article
Digitalization: The Route to Biopharma 4.0
It is evident that there is an urgent need to incorporate digital solutions at initial stages of process development, manufacturing, and quality assurance (QA).
Digitalization in pr…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
A risk-based approach to identifying potential residual impurities is important for understanding any risks to the product quality and potentially the patient. It also allows the development of an opt…
Article
Improving Upstream Predictability
“Using automation, process analytical technologies (PAT), and advanced multivariate analysis has enabled the industry to control process performance and product quality more closely than ever before,”…
Article
Understanding Validation and Technical Transfer, Part 3
It is one part of the overall product control strategy and forms the basis for the critical quality standards (CQAs) that will be approved by regulatory authorities. The product specification is estab…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Currently, we are observing a trend toward connecting process condition-monitoring to accurate product quality-control during processing, by very specific techniques such as in-situ mass spectrometry …
Article
Bioburden Control in the Biopharmaceutical Industry
…ecies, and Bacteroides fragilis, among others that should not be overlooked in microbiological quality control (2). Moreover, determination and identification of the nature and relative densities of …
Article
Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …