Bioprocess Online for bioanalytics, biopurification, bioproduction

The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable

In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

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EDITOR'S DESK

BIO 2026: Crowley On Competing With China And Modernizing The FDA
Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.

Essential CMC Elements For A Therapeutic Secretome

Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.

Midyear Pulse Check: What's Shaping Biopharma In 2026?

This article summarizes the major developments and industry pressures highlighted by Life Science Connect editors in the "Better Biopharma" midyear editorial roundtable.

Reflecting On Continued Turbulence At The FDA

Bioprocess Online's Editorial Advisory Board responds to former FDA commissioner Marty Makary’s resignation amid a prolonged period of instability at the agency.

Insufficient Vendor Data Is Hamstringing Single-Use Adoption

Audience polls and expert insights reveal insufficient vendor data as the main bottleneck stalling advanced single-use technology adoption. Explore that and other key takeaways in this recap of the Bioprocess Online Live event on "Closing The Adoption Gap For Advanced Single-Use Materials."

GUEST COLUMNISTS

The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
AI can close CAR-T’s access gap by replacing fragmented community delivery handoffs with automated orchestration across referral, reimbursement, logistics, and monitoring.
Building A Self-Driving Lab For LNP Development
With commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
Exploring Takeda's Template For Sustainable Steam Generation
Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.
Addressing The Particulate Challenge In Cell Therapy Products
Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.
Let's Stop Treating Allogeneic Cell Therapy As One Thing
Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.
Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.
Top 5 Challenges In Antibody-Oligonucleotide Manufacturing
AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.
Transforming Computer System Validation In The Life Sciences Industry
Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

BIOPROCESSING WHITE PAPERS

Incremental Adoption Of A Modular Operations Platform
Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.

Enhancing Biopharmaceutical Production Through Advanced Mixing
6/30/2026

Eliminate particulate contamination and product degradation in downstream bioprocessing. Learn how frictionless, levitating impeller technology ensures low-shear mixing and high yields.
Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives
11/3/2025

Due to the complexity of bispecifics, Fc-fusion proteins, and Fab fragments, their manufacturing poses added purification challenges and requires a robust toolkit of purification techniques.
ADC Manufacturing: Practices, Challenges, And The Road Ahead
6/15/2026

ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.
Improvements In ADC Efficacy And Stability
3/17/2026

Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.
Stopper Migration In Frozen Pre-Filled Syringes
10/16/2024

Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

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BIOPROCESSING APP NOTES & CASE STUDIES

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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.