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Why Your MVP And Its Evolution Matters To Manufacturing

Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

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EDITOR'S DESK

The 9 Fastest-Growing Outsourcing Segments
Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

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.

GUEST COLUMNISTS

Strained Manufacturing, Complexity Stymie In Vivo Progress
Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.
To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
Ask The Pros — The Latest In HCP Monitoring
Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.
Lessons In Quality From Sanofi's Plai.qa
The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.
The Promise And Paradox Of QbD
The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.
The Future Of Biotech Outsourcing: Essential Skills For Program Managers
The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.
Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work
Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.

BIOPROCESSING WHITE PAPERS

Antibody-Drug Conjugates – Catalysts For Chemistry
Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

Cell Line Development: The Linchpin In Biotherapeutic Development
1/4/2024

Review key factors for building a reliable CLD strategy, and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.
Avoiding The Pitfalls Of PQR
10/9/2024

Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."
Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs
10/16/2024

Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.
A Guide To Accelerating Cell Line Development For Commercial Production
7/11/2025

Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
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.

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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.