Bioprocess Online for bioanalytics, biopurification, bioproduction

FDA Headquarters MD-GettyImages-2278014569

Complete Response Letters For CGTs Share This Common Theme

One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

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

Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
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.

BIOPROCESSING WHITE PAPERS

T Cells In Immunotherapies: The Key Progress Underway
CAR-T therapies now make up 73% of active pipeline programs, yet solid tumors remain largely out of reach. Where is T cell immunotherapy headed next, and what does it mean for your pipeline strategy?

Quality: The Link Between Platform, Processes, And Patients
2/18/2025

Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.
Where Innovation And Investment Reduce Drug Development Risk
6/12/2026

How strategic investments in development, manufacturing, and clinical supply are helping organizations reduce risk and accelerate drug development.
Optimizing Safety Measures For rAAV Therapies
10/11/2024

Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
Immunogenicity Risk Assessment In Drug Candidate Selection
1/22/2025

Identify and address potential anti-drug immune responses early in development to streamline your drug’s path to clinical success—start smart and finish fast.
Accelerate Lead Times Through Seamless External Collaboration In Quality
5/21/2026

As CDMO networks expand, disconnected quality processes create delays and risk. Learn how seamless external collaboration improves visibility, accelerates approvals, and strengthens sponsor–partner relationships—helping teams move faster without compromising compliance.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

EDITORIAL COLLECTIONS KNOWLEDGE CENTER

Editorial Collections are subscriber-only, curated resources that combine expert interviews, feature articles, and industry analysis to help readers better understand emerging trends, operational challenges, regulatory developments, and best practices shaping the biopharma industry.

More Editorial Collections