Kinetics of Trisulfide-to-Disulfide Conversion of Therapeutic IgG1 Monoclonal Antibodies Under Physiological Conditions: A Case Study of Casirivimab And Imdevimab.

The percentage of trisulfide variants is a product quality metric that is monitored during the manufacture of monoclonal antibody (mAb)-based therapeutics. Results from earlier preclinical studies revealed that trisulfide linkages in mAbs are rapidly converted to disulfides in circulation. In this study, casirivimab and imdevimab, which are both IgG1 subclass mAbs that target the non-overlapping epitopes in SARS-CoV2 Spike protein, are used as models to study the kinetics of trisulfide-to-disulfide conversion in vivo in human circulation.

Feasibility of a Remote-based Nutrition Education and Culinary Skills Program for Young Adults With Autism Spectrum Disorder.

Objective: To evaluate the feasibility of a remote-based nutrition education and culinary skills program for young adults with autism spectrum disorder (ASD).

Methods: Thirteen young adults with ASD (26.6 ± 4.

Speed and need: twin development challenges in rapid response for a SARS-CoV-2 antibody cocktail.

Neutralizing antibodies are one available tool for the treatment of infectious diseases. Speed in developing monoclonal antibody treatments is an understood requirement for emerging infectious diseases, and need for COVID-19 treatments during the worldwide pandemic has provided additional urgency. Process development (at Regeneron) and technology transfer (within Regeneron and to Genentech) of casirivimab and imdevimab (REGEN-COV™ or Ronapreve™) manufacturing processes have addressed speed and need with selected purification and cell culture examples provided, respectively, for these two development challenges.

Metabolic analysis of the asparagine and glutamine dynamics in an industrial Chinese hamster ovary fed-batch process.

Chinese hamster ovary (CHO) cell lines are grown in cultures with varying asparagine and glutamine concentrations, but further study is needed to characterize the interplay between these amino acids. By following C-glucose, C-glutamine, and C-asparagine tracers using metabolic flux analysis (MFA), CHO cell metabolism was characterized in an industrially relevant fed-batch process under glutamine supplemented and low glutamine conditions during early and late exponential growth. For both conditions MFA revealed glucose as the primary carbon source to the tricarboxylic acid (TCA) cycle followed by glutamine and asparagine as secondary sources.

Transition of a Judo Program from In-Person to Remote Delivery During COVID-19 for Youth with Autism Spectrum Disorder.

Objectives: To examine the feasibility of a remote judo program for high school students with autism spectrum disorder (ASD) during the COVID-19 pandemic.

Methods: Nine high school students with ASD had been participating in an in-person judo program that transitioned to a livestream format once the stay-at-home orders were mandated. The students completed surveys regarding their experience with the remote sessions.

Brief report: The impact of the COVID-19 pandemic on health behaviors in adolescents with Autism Spectrum Disorder.

Background: There is concern that the COVID-19 pandemic may negatively affect health behaviors in youth, especially youth diagnosed with Autism Spectrum Disorder (ASD).

Objective: The purpose of this paper was to examine changes in physical activity, screen-time, and sleep in adolescents with ASD due to the COVID-19 pandemic.

Methods: Nine adolescents with ASD completed surveys measuring physical activity, screen-time, and sleep duration prior to and during the pandemic.

Implementation of a school-based Fitbit program for youth with Autism Spectrum Disorder: A feasibility study.

Background: School settings may be optimal for physical activity interventions for youth with Autism Spectrum Disorder (ASD). Additionally, consumer-based fitness trackers may encourage youth with ASD to increase their physical activity levels, however, no studies have examined whether a fitness tracker program would be feasible in youth with ASD.

Objective: To examine the feasibility of a 12-week school-based Fitbit© program for youth with ASD.

A general evidence-based sequence variant control limit for recombinant therapeutic protein development.

Sequence variants (SVs) resulting from unintended amino acid substitutions in recombinant therapeutic proteins have increasingly gained attention from both regulatory agencies and the biopharmaceutical industry given their potential impact on efficacy and safety. With well-optimized production systems, such sequence variants usually exist at very low levels in the final protein products due to the high fidelity of DNA replication and protein biosynthesis process in mammalian expression systems such as Chinese hamster ovary cell lines. However, their levels can be significantly elevated in cases where the selected production cell line has unexpected DNA mutations or the manufacturing process is not fully optimized, for example, if depletion of certain amino acids occurs in the cell culture media in bioreactors.

Protective strategies and alcohol use among college students: ethnic and gender differences.

This study investigated differences in alcohol consumption and the use of protective strategies (i.e., eating and designated drivers) between European American, African American, and Hispanic American college students.

Osteoporosis: prevention and implications for social work practice and policy.

Osteoporosis is one of the major disorders of our time and is increasing at an alarming rate. It affects over 10 million women in the United States and is expected to affect 14 million by the year 2020. There are a number of risk factors for osteoporosis that are of a modifiable nature; however, many women do not take the necessary precautions to prevent the disease.

Understanding and acting on the growing childhood and adolescent weight crisis: a role for social work.

The childhood and adolescent overweight and obesity rates are rising at an alarming rate. Numerous individual, family, community, and social factors contribute to overweight and obesity in children and are explored. If left unaddressed, the epidemic of childhood and adolescent overweight and obesity may lead to amplified problems for individual children--including acute and chronic physical and psychological complications--and for the larger social environment.

Behavioral health: Treatment and prevention of chronic disease and the implications for social work practice.

The public health problems in the new millennium are largely related to lifestyle. The illness industry has seen a large growth in the United States with health care expenditure accounting for 14% of the gross national product. The field of behavioral medicine seeks to include individual responsibility in the prevention of chronic disease.

Engineering sialic acid synthetic ability into insect cells: identifying metabolic bottlenecks and devising strategies to overcome them.

Previous studies have indicated negligible levels of both sialylation and the precursor N-acetylneuraminic acid (Neu5Ac) in a number of insect cell lines grown in serum-free medium. The overexpression of the human sialic acid 9-phosphate synthase (SAS) in combination with N-acetylmannosamine (ManNAc) feeding has been shown to overcome this limitation. In this study we evaluated the potential bottlenecks in the sialic acid synthesis pathway in a Spodoptera frugiperda (Sf9) insect cell line and devised strategies to overcome them by overexpression of the enzymatic pathway enzymes combined with appropriate substrate feeding.

Expression of a functional Drosophila melanogaster N-acetylneuraminic acid (Neu5Ac) phosphate synthase gene: evidence for endogenous sialic acid biosynthetic ability in insects.

In this study, we report the first cloning and characterization of a N-acetylneuraminic acid phosphate synthase gene from Drosophila melanogaster, an insect in the protostome lineage. The gene is ubiquitously expressed at all stages of Drosophila development and in Schneider cells. Similar to the human homologue, the gene encodes an enzyme with dual substrate specificity that can use either N-acetylmannosamine 6-phosphate or mannose 6-phosphate to generate phosphorylated forms of both the sialic acids, N-acetylneuraminic acid and 2-keto-3-deoxy-D-glycero-D-galacto-nononic acid, respectively, when expressed in either bacterial or baculoviral expression systems.