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Expert Voices: Why Aren't QC Labs Fully Automated Yet?

Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

EDITOR'S DESK

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.

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.

Complex Protein Development: Assay Early, Assay Often

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.

Delivering Large Molecules To The CNS, Overcoming The Blood-Brain Barrier

Aliada Therapeutics' CSO, John Dunlop, Ph.D., explains the company's blood-brain barrier-crossing delivery platform for large molecules.

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.

GUEST COLUMNISTS

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.
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.
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The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides.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.
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.
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.
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.
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.
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

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.

PEG In LNP Formulations: Addressing Challenges And Seeking Solutions
2/8/2024

Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.
Modeling The Economics Of Vaccine Manufacturing
5/26/2023

Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass
5/12/2023

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.
Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices
5/8/2024

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.
Exploring The Future Of Viral Vector Development And Production
1/17/2024

The demand for viral vectors continues to grow, making addressing the challenges related to their manufacturing and scale-up increasingly critical.

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.