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.
- From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
- From IV To Subcutaneous: It's Not About Convenience, It's About System Design
- New Research: Co-Expression Could Make Plant-Based Systems Viable
- Quantifying Single-Use Waste Produced During mAb Manufacture
- From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
- The Systems And Choreography Needed For Grade B ATMP Material Transfer
- Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
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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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.
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Quantifying Single-Use Waste Produced During mAb Manufacture
Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
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From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
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The Systems And Choreography Needed For Grade B ATMP Material Transfer
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
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Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
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Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
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Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
BIOPROCESSING WHITE PAPERS
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Finding An Optimal Harvest Solution By Considering Cost And Sustainability
Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Explore the benefits of a single-use centrifuge over traditional depth filtration methods.
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Excellence In Peptide And Oligonucleotide Purification11/5/2025
Explore how digital tools are advancing peptide purification, with a focus on GLP-1 receptor agonists, as well as how process efficiency can be accelerated through real-time insights.
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Achieve Higher Targeted Concentrations9/30/2025
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
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Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery2/4/2026
Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.
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Improving Gene Therapy Development With Organ-On-A-Chip Technology8/7/2024
Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.
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Perspectives On Performance, Scalability, And Regulatory Compliance10/28/2024
Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.
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
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.11.26 -- Process Control, Vibe Coding, And Comparability In Biosimilars
- 04.11.26 -- Bioprocess Online Best Of March
- 04.10.26 -- STREAM Edition: Investing In Early-Stage Oncology With Yosemite's Dan McHugh
- 04.10.26 -- The Systems And Choreography Needed For Grade B ATMP Material Transfer
- 04.09.26 -- New Editing Modalities Driving Scalable Genomic Medicine