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Bayer's Supply Network-Centric Approach To Digitalization

Shifting away from paper records is the nonnegotiable first step toward implementing novel technology. Here's how one company is approaching the monumental task.

EDITOR'S DESK

How Cidara Got Its Molecule Back
In a dramatic turn of events that makes for some great storytelling, Cidara's novel drug-Fc conjugate, once locked up in a deal with J&J, is now squarely back in the biotech's hands and moving forward with an aggressive phase 2b study.

Suppliers Pushing Novel Analytical Methods Testing Forward

The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?

Tune Therapeutics On Clinical Readiness, Technology Adoption

Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

Discovery vs. Hypothesis-Driven Cell Line Development

Susan Sharfstein, Ph.D., explains how discovery-driven research can further our understanding of cellular biology and ultimately inform cell line development.

How Platform Technologies Are Shaping The Gene Therapy Landscape

Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.

GUEST COLUMNISTS

USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli
Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.
Are We Witnessing A New "Age Of The CDMO"?
Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.
The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.
Embracing An Economic Model For Agile Process Development
If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?
Solving The Leukopak Supply Chain Issue With Cryopreservation
Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.
Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.
Is The BIOSECURE Act The First Real Step Toward Reshoring?
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
Research Explores Alternative To EU-Banned Triton X-100
One of the best-known viral inactivation agents is now banned in the EU. A group of scientists explored Virodex TXR-1 as a suitable alternative. Here's what they found.

BIOPROCESSING WHITE PAPERS

Mycoplasma Contamination In Biopharmaceutical Manufacturing
Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.

Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024

Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
Methods For Determining Equipment Capability Of Freeze-Dryers
10/16/2024

Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
Gene And Cell Therapy: Planning For Manufacturing Success Early
1/16/2023

As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
A Comparative Analysis Of Mixing Characterization Methods
7/19/2023

In the bioprocessing industry, there is no single, standard method for measuring mixing performance. Here, we investigate the four most widely used methods for measuring mixing time.
Why Should CDMOs Adhere To The New CDER's Rating System?
5/16/2024

Delve into the benefits of the FDA's Quality Management Maturity (QMM) program, the rating system’s evaluation criteria, challenges, and steps to overcome these hurdles and achieve excellence.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

23_10_BPO_MilliporeSigma_VaccineEbook_300x200

This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.