Bioprocess Online for bioanalytics, biopurification, bioproduction

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The Matryoshka Model: The New Face Of Contract Packaging In Pharma

Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

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EDITOR'S DESK

Experts' Advice On Facility Design And Construction
This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs

According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will impact your U.S.-based CDMOs.

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.

GUEST COLUMNISTS

Clues To Mapping A Crisis-Ready Tech Transfer Playbook
One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.
How To Automate Bioprocesses Without Locking Out Future Upgrades
Introducing automation now means you limit your ability to upgrade later. Early attention could give you options when the next generation of technology rolls around.
To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions
In Part 1, we introduced the critical link between CMC and prospective investors and/or licensees. Here we conclude with suggestions for how CDMOs can lend expertise early in discovery/development to improve the probability of securing investment or license for their clients.
Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services
The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?
Lilly's Calculated Approach To Upgrade Trade-Offs
If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.
How APBio Builds Multispecific Analytical Target Profiles
Some attributes require an elevated level of attention, in particular when it comes to analyzing chain pairing, folding fidelity, and aggregation.
First AMT Program OK'd Under New FDA Designation — Here's What To Know
The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.
How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities
A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.

BIOPROCESSING WHITE PAPERS

Three Key Strategies To Guide Efficient And Effective Recall Management
Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

Building Local Biomanufacturing Capacity In South Africa
2/11/2025
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
Process Analytical Technology In The ADC Bioconjugation Process
4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
8/14/2023
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
The Complete Flow Cytometry Guide
9/24/2024
This guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
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."

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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.