Patient-centric Comparability Assessment of Biopharmaceuticals.

The comparability assessment of a biological product after implementing a manufacturing process change should involve a risk-based approach. Process changes may occur at any stage of the product lifecycle: early development, clinical manufacture for pivotal trials, or post-approval. The risk of the change to impact product quality varies.

Development, validation, and implementation of a robust and quality control-friendly focused peptide mapping method for monitoring oxidation of co-formulated monoclonal antibodies.

Monoclonal antibody (mAb) coformulation containing two therapeutic proteins provides benefits of improved therapeutic efficacy and better patient compliance. Monitoring of the individual mAb stability in the coformulation is critical to ensure its quality and safety. Among post-translational modifications (PTMs), oxidation is often considered as one of the critical quality attributes (CQAs) as it potentially affects the structure and potency.

Factors Influencing Patient Preferences for Telehealth Cancer Genetic Counseling During the COVID-19 Pandemic.

Purpose: With onset of the COVID-19 pandemic, telehealth became the primary modality for health care appointments. This study examined patient experiences with and preferences for telehealth at a cancer genetic counseling clinic throughout the first 6 months of the pandemic (March-August 2020).

Methods: An anonymous survey assessed patient demographics; usage and prior experience with technology; emotional responses, technical experiences, and satisfaction with the telehealth appointment (via the Genetic Counseling Satisfaction Scale and Visit-Specific Satisfaction Questionnaire); preference for future telehealth; and recommendation of telehealth to others.

Targeted Host Cell Protein Quantification by LC-MRM Enables Biologics Processing and Product Characterization.

Multiple reaction monitoring (MRM) is a liquid chromatography-mass spectrometry (LC-MS) based quantification platform with high sensitivity, specificity, and throughput. It is extensively used across the pharmaceutical industry for the quantitative analysis of therapeutic molecules. The potential of MRM analysis for the quantification of specific host cell proteins (HCPs) in bioprocess, however, has yet to be well established.

Geospatial mapping and data linkage uncovers variability in outcomes of foot disease according to multiple deprivation: a population cohort study of people with diabetes.

Aims/hypothesis: Our aim was to investigate the geospatial distribution of diabetic foot ulceration (DFU), lower extremity amputation (LEA) and mortality rates in people with diabetes in small geographical areas with varying levels of multiple deprivation.

Methods: We undertook a population cohort study to extract the health records of 112,231 people with diabetes from the Scottish Care Information - Diabetes Collaboration (SCI-Diabetes) database. We linked this to health records to identify death, LEA and DFU events.

Mass spectrometric characterization of the isoforms in Escherichia coli recombinant DNA-derived interferon alpha-2b.

The isoforms Iso-2, Iso-3, and Iso-4 of Escherichia coli-derived recombinant human interferon alpha-2b (rhIFN α-2b), generated by posttranslational modifications of the protein during fermentation, present a major problem in terms of purification and the yield of the drug substance. We report here the structural characterization of these isoforms by mass spectrometry (MS) methods. An extensive MS study was conducted on Iso-4, which is composed of up to 75% of the in-process IFN, and on the native rhIFN α-2b.

Transformational leadership behaviors in allied health professions.

Objectives: The aim of this study was to explore self-reported transformational leadership behavior profiles within the six largest allied health profession groups in the National Health Service in Scotland and to determine whether factors such as seniority of grade, locus of employment, and/or leadership training have a positive influence on transformational leadership behaviors.

Methods: A postal survey comprising the shorter version of the Multifactorial Leadership Questionnaire (MLQ) and contextual demographic information was completed by 753 allied health professionals from four Health Board areas across Scotland who were randomly selected through a modified cluster sampling technique. The MLQ contains 36 items that measure nine identified leadership factors; however, only the responses to the five transformational leadership factors are reported here.

Site of pegylation and polyethylene glycol molecule size attenuate interferon-alpha antiviral and antiproliferative activities through the JAK/STAT signaling pathway.

Therapeutic pegylated interferon-alphas (IFN-alpha) are mixtures of positional isomers that have been monopegylated at specific sites on the core IFN-alpha molecule. The pegylation results in lower in vitro specific activity associated with the core IFN-alpha molecule that is related to the site of pegylation and size of polyethylene glycol (PEG) attached. We prepared purified, homogeneous, positional pegylation isomers of IFN-alpha2b that were monopegylated using 5-30-kDa linear PEG molecules attached at 7 primary reactive amino acid residues: Cys(1), His(34), Lys(31), Lys(83), Lys(121), Lys(131), and Lys(134).

Detection and quantification of the human IgG4 half-molecule, HL, from unpurified cell-culture supernatants.

The presence and absence of inter-heavy-chain disulphide linkages contribute to the existence of the tetrameric (H(2)L(2)) and half (HL) human IgG molecules, respectively. Reduced effector response in the human IgG4 subclass presents an alternative therapeutic platform in a monoclonal-antibody (mAb) development program. During the initial cell-selection stage, titres of the recombinant human antibody present in crude cell-culture supernatants are determined by ELISA, a technique requiring nanogram quantities of mAb.