Identification of Mispairing Omic Signatures in Chinese Hamster Ovary (CHO) Cells Producing a Tri-Specific Antibody.

Monoclonal antibody-based therapy has shown efficacy against cancer, autoimmune, infectious, and inflammatory diseases. Multispecific antibodies (MsAbs), including trispecifics (tsAbs), offer enhanced therapeutic potential by targeting different epitopes. However, when co-expressed from three or more different polypeptide chains, MsAb production can lead to incorrect chain assembly and co-production of mispaired species with impaired biological activity.

Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development.

Monoclonality of mammalian cell lines used for production of biologics is a regulatory expectation and one of the attributes assessed as part of a larger process to ensure consistent quality of the biologic. Historically, monoclonality has been demonstrated through statistics generated from limiting dilution cloning or through verified flow cytometry methods. A variety of new technologies are now on the market with the potential to offer more efficient and robust approaches to generating and documenting a clonal cell line.

A Mixed-Method Assessment of a Pilot Peer Advocate Intervention for Rural Gender and Sexual Minorities.

Mental health disparities affect lesbian, gay, bisexual, transgender, and queer (LGBTQ) people in rural America. There are few empirically-based mental health interventions for this population. This exploratory study uses a mixed-method approach to assess implementation issues related to the feasibility, acceptability, appropriateness, and preliminary impacts of a novel peer-based intervention designed to enhance support and treatment engagement among rural LGBTQ people with mental distress and/or addiction issues.