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Internalizing Nanoparticle Therapeutic Development

De facto approaches to treating immune-mediated diseases aren’t very kind to the immune system itself. COUR Pharmaceuticals is leveraging nanoparticles, a purpose-built platform and in-house expression systems to build antigen-specific therapies that treat the root cause of autoimmune diseases.

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

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.
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

BIOPROCESSING WHITE PAPERS

The Medicines Of Tomorrow: A Primer On The Gene Editing Landscape
Learn about the distinction between gene therapy and gene editing, as well as the therapeutic potential of CRISPR treatments and the challenges associated with clinical trials and commercialization.

Setting The Standard In Cell And Gene Therapy: Perspectives On Performance, Scalability, And Regulatory Compliance
10/28/2024

Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.
Microbial Manufacturing Platform For Non-Platform Proteins
9/26/2024

Discover how CASPON® Technology can revolutionize your recombinant protein manufacturing processes and enhance efficiency.
Vial Breakage During Lyophilization: Root Causes And Mitigation
10/16/2024

Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs
5/16/2024

Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.
Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024

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

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

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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.