Bioprocess Online for bioanalytics, biopurification, bioproduction

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The Peril Of Analytical Methods Transfer

Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, manufacturing equipment or consumables change, and even process development personnel turnover place analytical decisions made early on under a microscope.

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

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.
Should You Be Using Unique Container Identification?
Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.
The Influence Of Flows In cGMP Architectural Design
In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.

BIOPROCESSING WHITE PAPERS

Safety, Containment, And Analysis Of Highly Potent Compounds
Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.

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.
Cryopreservation Of Cells: Preserving Cells For Future Use
9/11/2023

Take a closer look at the process of cryopreservation, which role it plays for cell banking, and which challenges have to be overcome to reach the successful cryopreservation of cells.
Reducing ADC Timelines With Integrated Development And Manufacturing Services
4/8/2024

ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
Recommendations For Successful IND Approval Of RNA-LNP Drugs
8/22/2023

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
The Benefits Of Incorporating Lean Methodologies Into Project Management
8/20/2024

Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.

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.