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Harch Ooi

As seen in: Bioprocess Online, Outsourced Pharma
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Articles

09.18.25 -- What If You Need Multiple CDMO Partnerships? (Discussing Resilience, Risks)

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By Harch Ooi, Ooi CMC Consulting, Tyler Jones, Louis Garguilo Verified
| Outsourced Pharma
Advancing the Future of Cell & Gene Therapy This 11-12 November, Cell 2025 unites 1,000+ experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development. Gain insights across cell culture, therapy development, and CGT manufacturing, and learn from world-renowned leaders Bobby Gaspar (Orchard Therapeutics), Christof Von Kalle, (Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford).
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09.03.25 -- Calculating The Right In-House/Outsource Mix For ADC Manufacturing

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By Harch Ooi, Ooi CMC Consulting, Natasha Van Rutten, Michael Eder
| Bioprocess Online Verified
Webinar: Streamlining Vaccine Purification: Techniques for Modern Modalities Advances in vaccine development demand faster, more efficient processes.
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Calculating The Right In-House/Outsource Mix For ADC Manufacturing

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By Harch Ooi, Ooi CMC Consulting, Louis Garguilo Verified
| Outsourced Pharma
Guest Column | August 21, 2025 By Harch Ooi, Ph.D., Ooi CMC Consulting Antibody-drug conjugate (ADC) manufacturing — and questions about whether to manufacture them in-house or with a partner — has gained increased visibility and interest as the field matures from a scientific curiosity to a modality that positively impacts the lives of cancer patients. The first ADC to receive regulatory approval was Mylotarg (gemtuzumab ozogamcin) in 2000 for treatment of acute myeloid leukemia (AML).
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