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3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche

Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.

EDITOR'S DESK

Outsourced Complex Protein Development Demands Special Considerations
Complex protein therapeutic innovators are often orchestrating the work of three, four, or more outsourced manufacturing partners at once. What goes into their selection criteria? Experts from ADC and fusion protein sponsors weigh in, with bonus commentary from a CDMO process development specialist.

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.

GUEST COLUMNISTS

The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
Computer Systems Validation Pitfalls, Part 1: Methodology Violations
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.
How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside
The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.
The Latest Strategies For Quantifying AAV Capsid Titer
Let's take a look at the most commonly used methodologies, including established and emerging techniques, and evaluate the pros and cons of each.
Sterility Assurance: The Fundamentals
Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.
Comparing In-house Vs. Outsourced Manufacturing Strategies For CGTs
Each approach has its advantages and drawbacks. This guide should help you decide which one, or perhaps a hybrid strategy, is best for your company.
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.
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.

BIOPROCESSING WHITE PAPERS

Controlling Trace Impurities In Chemically Defined Media
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.

Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents
11/13/2023

See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
The Advantages Of A Blended Learning Approach In Operator Training
5/30/2024

Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing
4/24/2024

Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
Next-Generation CRISPR Approaches
7/16/2024

By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.
Cold-Wall Or Convection? Critical Considerations For Application Selection
4/18/2023

Explore both traditional cold-wall and convection technology options thoroughly to discern which is most suitable for meeting your cold storage requirements for upcoming projects.

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.