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  1. Article ; Online: Crystalline Antibody-Laden Alginate Particles: A Platform for Enabling High Concentration Subcutaneous Delivery of Antibodies.

    Erfani, Amir / Schieferstein, Jeremy M / Reichert, Paul / Narasimhan, Chakravarthy N / Pastuskovas, Cinthia / Parab, Vaishali / Simmons, Denarra / Yang, Xiaoyu / Shanker, Apoorv / Hammond, Paula / Doyle, Patrick S

    Advanced healthcare materials

    2023  Volume 12, Issue 15, Page(s) e2202370

    Abstract: Subcutaneous (SC) administration is a desired route for monoclonal antibodies (mAbs). However, formulating mAbs for small injection volumes at high concentrations with suitable stability and injectability is a significant challenge. Here, this work ... ...

    Abstract Subcutaneous (SC) administration is a desired route for monoclonal antibodies (mAbs). However, formulating mAbs for small injection volumes at high concentrations with suitable stability and injectability is a significant challenge. Here, this work presents a platform technology that combines the stability of crystalline antibodies with injectability and tunability of soft hydrogel particles. Composite alginate hydrogel particles are generated via a gentle centrifugal encapsulation process which avoids use of chemical reactions or an external organic phase. Crystalline suspension of anti-programmed cell death protein 1 (PD-1) antibody (pembrolizumab) is utilized as a model therapeutic antibody. Crystalline forms of the mAb encapsuled in the hydrogel particles lead to stable, high concentration, and injectable formulations. Formulation concentrations as high as 315 mg mL
    MeSH term(s) Rats ; Animals ; Humans ; Alginates/chemistry ; Rats, Wistar ; Antibodies, Monoclonal/pharmacokinetics ; Subcutaneous Tissue/metabolism ; Hydrogels/chemistry
    Chemical Substances Alginates ; Antibodies, Monoclonal ; Hydrogels
    Language English
    Publishing date 2023-02-22
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2649576-4
    ISSN 2192-2659 ; 2192-2640
    ISSN (online) 2192-2659
    ISSN 2192-2640
    DOI 10.1002/adhm.202202370
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Pembrolizumab microgravity crystallization experimentation.

    Reichert, Paul / Prosise, Winifred / Fischmann, Thierry O / Scapin, Giovanna / Narasimhan, Chakravarthy / Spinale, April / Polniak, Ray / Yang, Xiaoyu / Walsh, Erika / Patel, Daya / Benjamin, Wendy / Welch, Johnathan / Simmons, Denarra / Strickland, Corey

    NPJ microgravity

    2019  Volume 5, Page(s) 28

    Abstract: Crystallization processes have been widely used in the pharmaceutical industry for the manufacture, storage, and delivery of small-molecule and small protein therapeutics. However, the identification of crystallization processes for biologics, ... ...

    Abstract Crystallization processes have been widely used in the pharmaceutical industry for the manufacture, storage, and delivery of small-molecule and small protein therapeutics. However, the identification of crystallization processes for biologics, particularly monoclonal antibodies, has been prohibitive due to the size and the flexibility of their overall structure. There remains a challenge and an opportunity to utilize the benefits of crystallization of biologics. The research laboratories of Merck Sharp & Dome Corp. (MSD) in collaboration with the International Space Station (ISS) National Laboratory performed crystallization experiments with pembrolizumab (Keytruda
    Language English
    Publishing date 2019-12-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2823626-9
    ISSN 2373-8065
    ISSN 2373-8065
    DOI 10.1038/s41526-019-0090-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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