Bioprocess Online for bioanalytics, biopurification, bioproduction

test tubes, dropper, glass vials, pharmaceutical innovation-GettyImages-2157720330

How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides

A class of enzymes previously believed to be specific and intolerant of change might actually have broad applicability.

EDITOR'S DESK

On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.
DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

The Death Of A Dogma: David Baltimore And Lessons For Modern Drug Discovery

Nobel laureate, David Baltimore passed away at 87 years old, on September 6, 2025. He was widely regarded as a scientific visionary who at just 37, co-discovered reverse transcriptase, an enzyme that flipped molecular biology on its head by showing that genetic information could flow from RNA back to DNA, not just the other way around.

Single-Use Standardization Starts At Home

During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

Unlocking The Pharmacological Potential Of Antibodies

Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains the company's Functional Antibody Selection Technology (FAST) platform and its approach to developing a pipeline of G protein-coupled receptor (GPCR) mAbs.

GUEST COLUMNISTS

September 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Should We Refocus On The Product, Then Engineer The Process?
Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.
CRISPR And iPSC Disease Modeling And Drug Screening
iPSCs combined with the CRISPR-Cas9 gene editing system can construct or repair mutations and establish highly accurate, controllable in vitro models.
Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards
This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.
Application Of CRISPR Technology In iPSC Gene Correction
The CRISPR-iPSC combination is becoming a core tool for precision medicine with advanced editing efficiency, differentiation control, and safety profiles.
What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.
Fermentation Of Live Biotherapeutic Products In cGMP Environments
We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting.
Survey: 30% Of Biopharmas Cite Cost, Productivity As Top Priorities
Both focus areas aim at the same outcome, stronger economics and sustainable competitiveness, according to BioPlan Associates' 22nd Annual Biomanufacturing Report.

BIOPROCESSING WHITE PAPERS

Support Of Scale-Up And Technical Transfer Through Understanding Equipment
See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

Regulatory Considerations For Excipients Used In Lipid Nanoparticles
8/15/2024

Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
AI Implementation To Enhance Quality
2/11/2025

Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
Cell Culture Process Scale-Up Challenges For Commercial-Scale PSC Manufacturing
3/5/2025

Allogeneic cell therapies offer incredible promise, but scaling up PSC manufacturing presents unique challenges. Explore these hurdles along with solutions for consistent, high-quality production.
Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity
2/14/2025

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.
Enhancing Safety And Efficacy Of mRNA-Based Therapeutics
2/11/2025

Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.