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Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing

A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.

EDITOR'S DESK

Key Takeaways From The 2024 Bioprocessing Summit
Editor Tyler Menichiello reflects on the topics and trends covered at this year's Bioprocessing Summit in Boston.

The ADC Market Is Ripening For Disruption

Where there is therapeutic demand, the industry will build capacity. But with ADCs, cytotoxic payloads and a fragmented contract manufacturing landscape make the path to clinical and commercial supply dauntingly complicated. Here's how the ADC manufacturing market is shaping up, and how it might ultimately shake out.

Are You Taking The HPCs In Your ADCs Seriously?

The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.

Are Bioprocess Equipment Standards A One-Sided Conversation?

Half of respondents to a recent survey of biopharmaceutical companies said the greatest challenge in further growing industry acceptance of single-use technology—which now comprises an eye-popping 85% of non-commercial-scale biopharma manufacturing infrastructure—is the greater challenge in further growing industry acceptance of single-use technology

Integrating Analytics And Automation In Cell Therapy Manufacturing

Experts from last month’s Cell & Gene Live event discuss practical ways to utilize emerging technologies.

GUEST COLUMNISTS

Wish SUS Cost Less? Survey Says Your Peers Do, Too
BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.
Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake
Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models.
Luxturna Maker Spark Therapeutics' Flexible Platform Approach
The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.
The Small Biotech's Checklist For FIH Trials
Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.
How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield
This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs.
Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.
Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing
In-silico tools are ubiquitous in development, but big hurdles prevent them from showing up meaningfully in commercial manufacturing. These tips could help clear them.

BIOPROCESSING WHITE PAPERS

Mitigating Early Development Risks
Discover how the efficient screening of biologic candidates accelerates the discovery process, reduces costs, and improves the likelihood of commercializing safe and effective drugs.

Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
2/15/2023

Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
A Mammalian Suspension Technology For Scalable rAAV Production
3/13/2024

Explore a HEK293 derived animal component-free suspension cell line as the foundation of an up to 2000-liters scalable and robust platform process that increases the speed of AAV manufacturing.
Leveraging Immunological Diversity For Covid-19 Antibody Discovery
5/16/2024

Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.
Streamlining And Standardizing Cell And Gene Therapies From Process To Product
1/13/2023

Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.
A Feeder-Free Platform For Generating Mature Natural Killer Cells
7/11/2024

NK cells represent a promising avenue for immunotherapy. Examine the advantages of NK cells in cellular immunotherapy and the importance of developing efficient activation and expansion platforms.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.