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
- Biopharma Facility Modular Design & Construction: Key Considerations
- A Practical Guide To Navigate The EU's Revised GMP Annex 1
- 5 Steps To Avoid Mismanaging Biopharma Grant Funds
- Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
- Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
- A CTO’s Journey Into Continuous Biomanufacturing
Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
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.
Biopharma Facility Modular Design & Construction: Key Considerations
In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.
A Practical Guide To Navigate The EU's Revised GMP Annex 1
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
5 Steps To Avoid Mismanaging Biopharma Grant Funds
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.
Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.
Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
A CTO’s Journey Into Continuous Biomanufacturing
At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.
The Environmental Impact Of Biopharma Continuous Manufacturing: Part II
Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.
PHARMA ONLINE WHITE PAPERS
Understanding Perfusion Terminology
To evaluate whether a perfusion application will work in a production process, standardized terminology is critical. This white paper explains key terms that are essential for understanding the process.
The Importance Of Aseptic Sampling Devices In A Bioburden Reduction Strategy8/31/2022
This paper delves deeper into aseptic sampling devices to explain how they offer exceptional performance in the effort to control contamination.
8 Best Practices For Compliant And Quick Software Validation In The Cloud7/6/2022
Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices.
Why Biological Indicators Survive A Validated Cycle5/10/2022
We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.
Regulatory Strategy Considerations For Working With The FDA Vs. The EMA8/8/2022
This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.
Software Tools For Pharmaceutical Lyophilization Process Development1/11/2022
Highlights from a webinar describing a software modeling tool developed to optimize conditions for the primary drying cycle while accounting for heterogeneity within and between batches of drug products.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.More Content Collections