Check out the results of DeciBio's Antibody-Drug Conjugates 2024 Industry Survey, which predict another bullish year for the growing modality.
- Precision Radiopharmaceuticals with Ratio's Jack Hoppin, Ph.D.
- Understanding And Navigating Diverse Regulatory Environments
- U.S. Biotech Is In For A Protracted Divorce From China
- A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies
- Developing & Implementing A Continuous Bioprocess Control Strategy
- Huh? Where Did That Environmental Monitoring Hit Come From?
- A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
1 In 300 People In The U.S. Is Living With HIV. That’s Not Okay With Jeff Galvin.
By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.
You’ve heard San Francisco was buzzing with cautious optimism last month. You’ve seen the M&A activity that’s buoying spirits and you know inflation and interest rates are stabilizing, if not improving. You may not have considered these three trendlines, offered by a guy who spent his time at JPM doing more listening than anything.
Despite the continuation of a poor funding climate in biotech, 2023 was a big year for antibody-drug conjugates (ADCs).
RNA vaccines have shown promise in preventing infectious diseases and treating cancer, but clinical development varies markedly between the two. HDT Bio’s Dr. Berglund discusses this and how they can be improved.
Members of Caring Cross and UC Berkeley's Innovative Genomics Institute and Office of IP And Industry Research Alliances discuss the important role technology transfer offices (TTOs) play in improving ATMP accessibility. TTOs can accomplish this by designing "strings-attached" research and licensing deals upstream in product development.
A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies
Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.
Developing & Implementing A Continuous Bioprocess Control Strategy
A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.
Huh? Where Did That Environmental Monitoring Hit Come From?
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
FDA’s CBER Issues Final Guidance For CAR T Cell Products
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
New DSCSA Guidance Details Layers Of Verification System Requirements
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
Stable Cell Lines: Stepping Stones For Continuous Viral Vector Manufacturing
Amid the increasing need for greater volumes of therapeutic molecules, proteins, and viral vectors, a promising technology started to develop — the stable cell line.
BIOPROCESSING WHITE PAPERS
De-risks Your Monoclonal Antibody Scale-Up Process
Improve your mAb production by adopting a technology platform approach using a fluid handling system that can transition from development to your final production volume.
Solving Cost And Supply Challenges In Biopharma Downstream Processing7/20/2023
In response to the growing demand for monoclonal antibodies, researchers are looking at different areas of the downstream process where they can improve efficiency and scalability.
Taking Charge Of Your Stability Program10/5/2022
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
AI Improving Inventory Management For Single-Use Systems Manufacturing8/23/2023
The use of AI and machine learning tools can begin the process of moving from predictive, human-driven inventory management and manufacturing processes to genuine, data-driven decision making
Match Your Development And Manufacturing Path To Your IND Milestones2/17/2023
The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.
An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market12/14/2023
Biotech and biopharma developers are increasingly relying on outsourcing partners to meet both clinical and commercial research, development, and production needs. CDMOs that provide end-to-end services, including secure supply chains, can help biologics developers meet accelerated timelines and establish a real competitive advantage in today’s competitive market.
BIOPROCESS ONLINE CONTENT COLLECTIONS
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.More Content Collections