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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Streamline Your mAb Manufacturing With Strategic Development And CDMO Compatibility
Though the journey to mAb development begins at lab scale, for clinical trials and commercial distribution, a production process must be streamlined and scalable to 2,000 L production and above.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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Process Development For Lyophilized Products10/16/2024
Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
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Designing A Disinfectant Study For Your Cleanroom5/14/2024
Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.
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The Importance Of Quality In Raw Material Selection1/16/2025
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion8/4/2025
Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.
- 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
- 04.18.26 -- Cutting Costs, Timelines, And Downstream Bottlenecks
- 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