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The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations

The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

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

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.
Defining When To Implement Technologies To Support Commercial Growth
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

BIOPROCESSING WHITE PAPERS

Five Essentials For Accurate Oligonucleotide Chemistry
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.

A Risk-Based Approach To Injectable Combination Product Development
3/14/2023

Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
The Value Of Engaging A Single CDMO For Comprehensive Biologics Services
5/16/2024

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.
Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks
9/11/2023

Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.
Inspection Of Injectable Products For Visible Particulates
8/8/2023

Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection
10/3/2024

Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

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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.