Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.
- Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences
- Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
- 5 Steps To Eliminate Weak Links In Your Data Governance
- Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
- Create The Correct Checklist To Land The Best CDMO
- A Methodology To Support Particle Investigations In Biopharma Products
- 1 Year Out, Where Do We Stand On DSCSA Implementation?
Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences
Rising interest rates, imploding cryptocurrencies, and erratic equities markets have upended assumptions about risk and returns during 2022. The “risk-free” rate has surged to more than 4% as of late November. Your pharma, biotech, or medical device company looking to raise cash needs to take the key considerations shared in this article into account.
Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.
5 Steps To Eliminate Weak Links In Your Data Governance
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
Create The Correct Checklist To Land The Best CDMO
When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
A Methodology To Support Particle Investigations In Biopharma Products
Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
1 Year Out, Where Do We Stand On DSCSA Implementation?
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
BIOSIMILAR WHITE PAPERS
The Science Of Cell Therapy Thawing
A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.
Optimizing Lipid Formulations For Targeted RNA-LNP Applications9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
Key Stages In mRNA-Based Therapeutic Development9/13/2022
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
Explore Protein Function Using Surface Plasmon Resonance (SPR)5/20/2021
We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.
Regulatory Considerations For Alternative Microbial Methods2/28/2022
This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
De-Risking Biosimilar Development With A Clinically Validated And Commercially Proven Disposable Autoinjector6/2/2022
Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.