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By Evan Shirley and Janel Firestein, Clarkston Consulting | Novo Holdings, the parent company to Novo Nordisk, announced a deal last week to acquire Catalent, the global CDMO, at a value of $16.5 billion. In the same breath, Novo Holdings announced they will sell three sites directly to Novo Nordisk, implying that the rest of the assets of the company will continue to operate as a stand-alone CDMO. This article unpacks the acquisition, discussing questions such as “what does it mean for customers?” and “Does this deal reshape the CDMO market?” |
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars | White Paper | Prepared by Adam Tuszyner, Mabion | The presence of antidrug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development. |
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Developability Assessment Of Three Therapeutic Antibodies | Poster | By Tao Bi, Yesenia Aguilar, Paul Phelan, Laura McDevitt, Henry Yong, David Gae, Anjali Patel, Wen-Rong Jiang, Tao He, and Zhiping Yao, JOINN Biologics | Review studies for three monoclonal antibody drug candidates utilizing a panel of small-scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability. |
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Simulated Control Strategy For Product Diversion Management | Poster | By Rui Wheaton, Ahsan Munir, Thomas Erdenberger, Huanchun Cui, and Thomas Ransohoff, Resilience US, Inc. | Explore a manufacturing platform that integrates perfusion bioreactor technology, continuous product capture, low pH viral inactivation, and polishing steps, as well as viral filtration and formulation steps. |
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The Business Case For Pharmaceutical Continuous Manufacturing | White Paper | By Richard Steiner, Pharmatech Associates - A USP Company | Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers. |
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| PHARMAP 2024 | The Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) welcomes main representatives of the pharmaceutical industry, including top-level management, key technical manufacturing and packaging specialists, supply chain and procurement experts, and heads from manufacturing and packaging pharma technology companies. The Congress is held on April 22-23, 2024, in Amsterdam, the Netherlands. Among the regular participants are Novartis, Takeda, Bayer, Zentiva, Pfizer, Merck, and others. |
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mAb And r-Proteins Contract Testing, Development, And Manufacturing | MilliporeSigma | Millipore CTDMO Services provides deep expertise and flexible solutions across development and manufacturing for monoclonal antibodies, bi-specific antibodies, fusion proteins, or antibody fragments. We work with our clients to balance risk, optimize speed, and support all aspects of regulatory compliance on the journey to market. |
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cGMP Aseptic Manufacturing And Sterile Fill/Finish | Ascendia Pharma | Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill/finish policy to improve drug bioavailability. Aseptic fill/finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. |
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Late-Stage Customization | PCI Pharma Services | Learn about the benefits of a late-stage customization approach, including how it can support a leaner, more responsive supply chain, ensuring life-changing therapies reach patients more efficiently. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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