Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.
- How To Implement Post-Approval Changes On A Global Level
- March 2026 — CDMO Opportunities And Threats Report
- The Business Case For Continuous Manufacturing In Biologics
- Mastering Biotech's Insourcing/Outsourcing Trade-Offs
- Drug-Device Combination Products: 4 Evolving Platforms For 2026
- Integrate Upstream/Downstream To Reduce Development Risks And Costs
- From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
EDITOR'S DESK
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A Biotech Business Model That's Investor-Friendly
For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.
Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.
AbbVie's head of biologics purification development and digitization teams, Moiz Diwan, Ph.D., and independent technology consultant Kat Kozyrytska share their thoughts on AI and smart technology adoption in this recap of the Bioprocess Online Live event, “How Digital Tools Are Accelerating Biopharma Development.”
Bioprocess Online's chief editor, Tyler Menichiello, reflects on the year and provides a preview of what to expect in 2026.
Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.
GUEST COLUMNISTS
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How To Implement Post-Approval Changes On A Global Level
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.
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March 2026 — 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.
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The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.
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Mastering Biotech's Insourcing/Outsourcing Trade-Offs
Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.
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Drug-Device Combination Products: 4 Evolving Platforms For 2026
Biologic advantage won’t come from better biology alone, but from delivery technology and designing the full experience around patients, providers, and supply chains.
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From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
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From IV To Subcutaneous: It's Not About Convenience, It's About System Design
IV→SC transition extends beyond dose, volume, concentration, and device; it requires integrated system design, not a series of isolated optimizations.
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New Research: Co-Expression Could Make Plant-Based Systems Viable
By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.
BIOPROCESSING WHITE PAPERS
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Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC
Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.
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Exploring Perfusion Technology For Virus Manufacturing Process Intensification1/23/2026
Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.
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FIH: Reach Milestones Sooner With A Technology-Driven Approach2/12/2026
Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.
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Performance Characteristics Of The Mobius® ADC Reactor For Conjugation10/22/2024
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
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A Journey To Boundless Automation In Life Sciences7/1/2025
Boundless automation reimagines industrial computing through seamless integration of the intelligent field, edge, and cloud, unified by a real-time data fabric that enables digital transformation.
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Accelerated Development Of Solid Oral Dosage Formulation For IND Submission12/11/2024
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
BIOPROCESSING APP NOTES & CASE STUDIES
- Integrate Upstream/Downstream To Reduce Development Risks And Costs
- Taking The First Steps Towards Digitalizing Biopharma Development
- Bioprocess Online's 2025 Editorial Reflections
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Achieving Inspection-Readiness For Cell Sorters And Analyzers
- EU And PIC/S Annex 1: CCS Shortfalls After 2 Years Of Implementation
- OneTeam™: Setting A New Standard for Biotech Program Visibility
- Less Risk, More Speed -The New Blueprint For Bioconjugate Development
- Industrializing Cell Therapy With Perfusion
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.17.26 -- STREAM Edition: Reprogramming T Cells And Reducing Manufacturing Costs With RegCell's Michael McCullar, Ph.D.
- 04.17.26 -- All The Ways Global Biopharma Still Grapples With Annex 1
- 04.16.26 -- How Will U.S. Tariffs And The BIOSECURE Act Impact Global Biopharma Markets?
- 04.15.26 -- What It Takes to Maximize Your Biologic's Chances of Clinical Success
- 04.15.26 -- From IV To Subcutaneous: It's Not About Convenience, It's About System Design