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Analytics And Cross-Functional Communication: Keys To Purifying Complex Molecules

This summary features key takeaways from the Bioprocess Online Live event, "Challenges And Considerations For Purifying Multispecific Molecules."

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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

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.
Will Genome Modifications Define Next-Gen AAV Vectors?
AAV vectors composed of naturally occurring capsids are suboptimal. Gentle genetic alterations hold promise for safer, more efficient therapy.
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.

BIOPROCESSING WHITE PAPERS

Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.

Overcoming Challenges To High-Concentration Formulation Development
3/25/2025

Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
Navigating Your Digital Journey To AI Success
11/2/2023

The first critical step in your digital journey, before implementing AI, is to ensure you’re at the right level of digital maturity.
The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics
5/16/2024

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.
Best Practices In Commissioning And Qualification
7/5/2024

An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT
11/21/2024

This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

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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.