Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.
- How Platform Technologies Are Shaping The Gene Therapy Landscape
- Advanced, Cost-Saving Techniques Improving Cell Therapy Production
- Gene Therapy CMC Experts On Late-Stage Process Changes
- Team Topologies For Outsourced CMC Development
- EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides
- This Digital Twin Approach Aims To Optimize ATMP Production
- Strategies To Address FDA CMC Trends For mRNA Therapies
EDITOR'S DESK
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Considerations For AI Use In Biomanufacturing
Expert's from this month's Bioprocess Online Live event discuss different use cases for AI and shared their thoughts on the adoption of these technologies.
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.
Experts from FyoniBio, SOTIO, and Vera Therapeutics weigh in with first-hand experience on how process decisions made very early on can influence – beneficially or detrimentally – the efficiency of upstream and even downstream operations in the development of novel protein therapeutics.
Aliada Therapeutics' CSO, John Dunlop, Ph.D., explains the company's blood-brain barrier-crossing delivery platform for large molecules.
Editor Tyler Menichiello reflects on the topics and trends covered at this year's Bioprocessing Summit in Boston.
GUEST COLUMNISTS
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Advanced, Cost-Saving Techniques Improving Cell Therapy Production
Low throughput and intense resource demand limit patient access to cell therapies. Automation and in vivo manufacturing are poised to lower those barriers.
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Team Topologies For Outsourced CMC Development
When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.
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EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides
The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.
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This Digital Twin Approach Aims To Optimize ATMP Production
Manufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.
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Strategies To Address FDA CMC Trends For mRNA Therapies
A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.
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Araris Doubles Down With Dual-payload ADC
Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.
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5 Strategic Advantages Of Manufacturing ADCs In-house
Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.
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Accelerate CMC Development With Team Topologies
A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.
BIOPROCESSING WHITE PAPERS
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How To Make The Best LNPs
There are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation.
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PEG In LNP Formulations: Addressing Challenges And Seeking Solutions2/8/2024
Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.
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Modeling The Economics Of Vaccine Manufacturing5/26/2023
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices5/8/2024
Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.
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Exploring The Future Of Viral Vector Development And Production1/17/2024
The demand for viral vectors continues to grow, making addressing the challenges related to their manufacturing and scale-up increasingly critical.
BIOPROCESSING APP NOTES & CASE STUDIES
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 CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Full Speed Ahead: Accelerating Your CHO Bulk Harvest Testing Using Rapid Methods
- The Next Generation Of Thermal Stability Testing For Biologic Drugs
- What Do You Need To Qualify A Single-Use Assembly?
- Topical Pharma: A Rheologist's Guide To Regulatory Confidence
- The Role of Peptones In Enhancing Efficiency
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 10.04.24 -- Cell Culture Media: Partners Poised To Meet Demand
- 10.04.24 -- Revolutionize Your Drug Delivery With Nanoformed APIs
- 10.04.24 -- Capacity, AI Driving Single-Use Bioprocess Probe And Sensor Uptake
- 10.03.24 -- Embracing Biotech Chaos, A New Genome Engineering Approach, Pivoting to RNA, and more!
- 10.03.24 -- Considerations For AI Use In Biomanufacturing