In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
- What To Know About — And How To Apply For — FDA's PreCheck Pilot
- MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
- A Novel In Vitro Glycosylation Approach For Difficult PTMs
- Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
- Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
- A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
GUEST COLUMNISTS
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What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
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MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
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A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.
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Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.
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Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
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A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.
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The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."
BIOSIMILAR WHITE PAPERS
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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The Role Of Extractables Data In The Adoption Of Single-Use Systems8/29/2024
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
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Why Biopharma Breakthroughs Aren't Moving The Market10/20/2025
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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Ready To Demystify Organoids?7/1/2025
Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
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Is Sustainability The Key To Agile Biopharma Manufacturing?3/18/2025
In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
BIOSIMILAR APP NOTES & CASE STUDIES
- Raman As A Quality Control Tool For Cell Culture Media Preparation
- Overcoming The Solubility Challenges Of Antibody-Drug Conjugates
- Enhanced Flow Kit Performance With Leak And PUPSIT Testing
- Virus Retention Performance Under Diverse Processing Conditions
- Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Formycon Announces Positive Clinical Data For Keytruda Biosimilar Candidate FYB206 (pembrolizumab)
- SteinCares And Shilpa Biologicals Strike Into Licensing Agreement To Expand Access To Biosimilars Across Latin America
- Sandoz Confirms European Commission Approval For Ranluspec (ranibizumab), Further Strengthening Overall Biosimilars Leadership And Position In Ophthalmology
- Lupin Receives European Commission Approval For Biosimilar Ranibizumab
- Dr. Reddy's Announces USFDA Acceptance To Review Its Biologics License Application (BLA) For Proposed Interchangeable Biosimilar, Abatacept
- Zydus Launches Biosimilar Aflibercept 2 mg ANYRA For Advancing Ophthalmic Care
- Sandoz Receives US FDA Approval To Expand Enzeevu (aflibercept-abzv) Label For Multiple Retinal Indications
- FDA Approves FILKRI7™ (filgrastim-laha), Accord BioPharma's Biosimilar To NEUPOGEN® (filgrastim)
NEWSLETTER ARCHIVE
- 02.26.26 -- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- 02.19.26 -- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- 02.12.26 -- Building Enterprise Resilience From QRM Signals
- 01.29.26 -- The Latest In Upstream HCP Mitigation
- 01.15.26 -- SUS Insufficient For 40% Of Biopharma