Downloads
-
Calculating Process Capability Of Cleaning Processes With Completely Censored Data
10/31/2022
Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.
-
How Can Nanomedicine Innovations Combat Cancer?
10/24/2022
For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.
-
Digital Twins & The CGT Value Chain: A Universe Of Possibilities
10/21/2022
The cell and gene therapy revolution is coinciding with advanced digital technologies. At the forefront are digital twins, which combine at-scale computing, modeling methods, and IoT connectivity to create full-scale digital replicas of physical assets or real-world processes, such as factories, value chains, and even humans.
-
Assessing Quality Of mRNA Vaccines: Key Considerations
10/12/2022
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
-
Pharma 4.0 Software Methodologies In Biopharma And Medical Devices
10/10/2022
The life sciences industry has been using computer software testing methodology to validate software that is categorized to be GxP in alignment with the principles of good automated manufacturing practices and Industry 4.0 standards. This article discusses the methodologies of computerized system validation, computer software assurance, and the Agile approach.
-
6 Drug Discovery Learnings From The Lab
10/5/2022
With more than 25 years of experience, this author shares insights from the perspective of bench science that pertain to experimental design and data generation. These concepts apply not only to individual experiments but also more broadly.
-
Life Sciences RIM: Modernization & Moving Ahead
9/28/2022
Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
-
Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
9/16/2022
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
-
Lab-On-Chip Devices: Materials Considerations
9/15/2022
Material selection and testing can often be one of the critical challenges to developing microfluidic devices for the healthcare and life sciences markets. This article shares recommendations related to determining which physical properties are needed, potentially suitable materials, processing techniques, and analytical techniques.
-
5 Steps To Avoid Mismanaging Biopharma Grant Funds
9/7/2022
You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.