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Formulation Is Key For Y-mAbs' Self-Assembling Antibody

The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

EDITOR'S DESK

From BPI West: A Roundtable Discussion On Continuous Manufacturing
Process Development experts share their thoughts on continuous manufacturing at this year's BPI West, touching on its benefits and present barriers to adoption.

From BPI West: Key Challenges And Benefits Of Continuous Manufacturing

Continuous manufacturing was a hot topic of conversation at this year's BPI West. AstraZeneca's Ken Lee, Ph.D., weighs in during an exclusive interview with Bioprocess Online.

From BPI West: An Upstream Scientist's Advice On Target Glycosylation

Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.

2025 Cell Therapy Outlook From BPI West

Bioprocess Online and Cell & Gene spoke with Takeda’s Amy Shaw at BPI West to discuss the industry and her key takeaways from the conference.

Using AI And ML To Gain Insight Into Optimal Glycoforms

Bioprocess Online asked Nathan Lewis, Ph.D., to briefly explain the research he presented at BPI West 2025.

GUEST COLUMNISTS

Good Distribution Practice Is Evolving — Here's How
Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.
The 3 Phases of QRM – An Inspector's View
Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.
ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy
Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.
A Case For Paying Allogeneic Cell Therapy Product Donors
The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.
April 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.
Incorporating AI Tools Into Downstream Process Optimization
Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.
A Road Map For PAT Monitoring And Control
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
Is Early Automation The Key To Scalable Cell Therapy Manufacturing?
Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.

BIOPROCESSING WHITE PAPERS

Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

2024 Global Biopharma Sustainability Review
9/3/2024

What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
Phase-Appropriate Approaches To Manufacturing And Testing
3/14/2025

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
Cryopreservation Of Cells: Preserving Cells For Future Use
9/11/2023

Take a closer look at the process of cryopreservation, which role it plays for cell banking, and which challenges have to be overcome to reach the successful cryopreservation of cells.
Business Continuity Management: The Benzonase® Endonuclease Success Story
8/21/2024

Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing
5/7/2024

For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

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.