Contributions of supercritical fluid technology for advancing decellularization and postprocessing of viable biological materials

This review summarizes relevant literature on scCO2-assisted decellularization, and discusses major topics dominating the field, such as mechanism of action, effect of cosolvent and operational parameters, and range of results across different works.

The ATCC Genome Portal: Microbial Genome Reference Standards with Data Provenance

Lack of data provenance negatively impacts scientific reproducibility and the reliability of genomic data. The ATCC Genome Portal ( https://genomes.atcc.org ) addresses this by providing data provenance information for microbial whole-genome assemblies originating from authenticated biological materials. To date, we have sequenced 1,579 complete genomes, including 466 type strains and 1,156 novel genomes.

Investigating Alternative Container Formats for Lyophilization of Biological Materials Using Diphtheria Antitoxin Monoclonal Antibody as a Model Molecule

When preparing biological reference materials, the stability of the lyophilized product is critical for long-term storage, particularly in order to meet WHO International Standards, which are not assigned expiry dates but are expected to be in use for several decades. Glass ampoules are typically used by the National Institute for Biological Standards and Control (NIBSC) [PM1] for the lyophilization of biological materials. More recently, a clear need has arisen for the filling of smaller volumes, for which ampoules may not be optimal. We investigated the use of plastic microtubes as an alternative container for small volume fills. In this study, a recombinant diphtheria antitoxin monoclonal antibody (DATMAB) was used as a model molecule to investigate the suitability of plastic microtubes for filling small volumes. The stability and quality of the dried material was assessed after an accelerated degradation study using a toxin neutralization test and size exclusion HPLC. While microtubes have shown some promise in the past for use in the lyophilization of some biological materials, issues with stability may arise when more labile materials are freeze-dried. We demonstrate here that the microtube format is unsuitable for ensuring the stability of this monoclonal antibody.

Review on Analytical Methods for Determination of Lamivudine, Dolutegravir and Tenofovir Disoproxil Fumarate in Fixed Dose Combination

Pharmaceutical medicines play an important role in human life that helps to cure different diseases. For the chemical and pharmaceutical analysis of the drug effective quality control and pharmacodynamic and pharmacokinetic studies are needed. Several methods have been developed and validated for its pharmaceutical and biological materials since it was introduced as an important antiretroviral agent. The literature survey reveals that only four RP HPLC method and one HPTLC was developed for the simultaneous estimation of Dolutegravir, Lamivudine and Tenofovir disoproxil fumarate in tablet dosage form. These three drugs are used as antiretroviral medicines which are used for HIV or AIDS prevention and treatment. The goal of this review is to define and establish a simple, precise and selective method for estimating the dosage of Lamivudine, Tenofovir Disoproxil fumarate and Dolutegravir in biological and pharmaceutical dosage form using the HPLC, HPTLC, UPLC, UV Visible spectroscopy, LC/MS, Infrared spectroscopy, NMR spectroscopy, Microbiological assay, Electrochemical studies and Capillary electrophoresis. UV-detector HPLC is commonly used in pharmaceuticals and LC-MS are widely used for biological materials with mass and tandem mass spectrometer detector systems. Various parameters such as device suitability, process accuracy, precision, linearity, detection limit will validate the UV Visible spectroscopy and RP-HPLC technique.