Bioprocess Online for bioanalytics, biopurification, bioproduction

A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies

This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities.

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

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The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides.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

BIOPROCESSING WHITE PAPERS

Downstream Processing In The Age Of Precision Medicine
Explore alternative processes and solutions being suggested to combat the bottleneck created by downstream processing that is seriously impacting the overall production of treatments and vaccines.

Considerations And Strategies For Oligonucleotide Manufacturing Scale-Up
8/2/2023

To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this scale-up process brings challenges that must be addressed.
Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
6/29/2023

Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.
Expectations On The Pathway To GMP For Gene-Modified Cell Therapies
6/21/2023

Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
Leveraging The Immunological Diversity Of The Pentamice® Platform 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.
Revolutionizing Drug Discovery From "Undruggables" To AI
6/10/2024

Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

23_10_BPO_MilliporeSigma_VaccineEbook_300x200

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.