Bioprocess Online for bioanalytics, biopurification, bioproduction

Finding the hidden costs-GettyImages-1478035639

DEA Reveals Hidden Costs Of Analytical Validation Guidelines

By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

More Featured Editorial

EDITOR'S DESK

Overcoming Recovery Challenges In AAV Production
Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.

Preserving Tacit Knowledge In ADC Tech Transfers

ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.

Multispecific Manufacturability Starts With Molecular Design

AP Biosciences’ VP of antibody discovery, Jhong-Jhe You, Ph.D., explains the key design elements of multispecific antibodies and how they affect product developability.

On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle

At the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.

BIO 2026: Modernizing The FDA And Bolstering The Workforce

Bioprocess Online's chief editor, Tyler Menichiello, shares his key takeaways from the 2026 BIO International Convention in San Diego.

GUEST COLUMNISTS

Engineering Better ADCs, Part 2: Characterization, CMC, And More
Let's take a closer look at antigen selection and tumor biology, PK and PD, analytical characterization, CMC, toxicity, and more.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — 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.
ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.
Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
Sustainable Facility Design Brings Bayer Instant Savings
ROI for sustainability initiatives often come later as lower maintenance and utility costs. Bayer's pursuit of LEED certification led to substantial savings up front.
Why You Should Measure Comparability Debt Before Ever Starting A Study
When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

BIOPROCESSING WHITE PAPERS

Beyond The Label: Solving Traceability Challenges In Bioproduction
Standardizing raw material traceability and lot verification reduces variability, protecting bioprocess consistency and regulatory compliance.

The Importance Of Polymorph Screenings
5/6/2026

Discover how systematic polymorph screening reduces development risk, safeguards product performance, and enables confident solid‑form selection across the drug development lifecycle.
Better, Safer Science Through Proper Detergent Selection And Cleaning
6/22/2026

Enforce reliable lab results by improving washer performance, detergent selection, and rinsing to prevent residues, cross-contamination, and spotting—supporting reproducibility and compliance.
Why Compliance-Driven CDMOs Win Sponsor Contracts
2/5/2026

Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.
Delivering Critical Therapies With Speed And Safety
6/26/2026

Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.
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.

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.