Comparison of guidelines for biological ancillary materials used for the manufacture of gene and cellular therapy products in Asia.

Background Aims: Although biologiocal ancillay materials (AMs) have specific risk associated with their derivations, it plays key role to manufature cell and gene therapy (CGT) products. It is important to understand the regulation relevant to AMs for developers.

Methods: The authors investigated the guidelines and pharmacopeia (hereinafter referred to as "guidelines") for biological AMs used for the manufacture of CGT products in Asia (China, India, Japan, Korea and Taiwan).

Nonclinical and quality assessment of cell therapy products: Report on the 4th Asia Partnership Conference of Regenerative Medicine, April 15, 2021.

The 4th Asia Partnership Conference of Regenerative Medicine (APACRM) was held online on April 15, 2021, to promote regulatory harmonization of regenerative medicine products throughout Asia. Recognizing domestic regulatory guidelines within each country and region, and their underpinning rationales, is an important initial step toward a convergence of regulations. The 4th APACRM consisted of an open dialog with regulatory agencies regarding nonclinical and quality settings for cell therapy products (CTPs) through industry presentations and panel discussions with regulatory agencies.

Inheritance and developmental pattern of cerebral hernia in the crested Polish chicken.

A number of crested chicken strains, such as the Polish chicken, exhibit a bony protuberance in the anterodorsal region of their skulls. The shape of their brain shows the anatomical peculiarity that is characterized by the upthrusting of cerebral hemispheres, called "cerebral hernia." Some early works suggested that this phenotype may be caused by a genetic factor and any modifiers influencing the development of brain and/or skull.

Immunolocalization of aquaporin-4 in the brain, kidney, skeletal muscle, and gastro-intestinal tract of chicken.

Aquaporin-4 (AQP4), a member of the water channel family, has high water permeability and multi-functional potentiality. Although an avian AQP4 homolog has recently been identified, its overall localization is still largely unknown. This study demonstrates the presence of AQP4 in several organs of chicken by using a specific chicken AQP4 antibody.

Neonatal alloimmune thrombocytopenia caused by an antibody specific for a newly identified allele of human platelet antigen-7.

Background: Neonatal alloimmune thrombocytopenia (NAIT) is a neonatal disorder characterized by maternal alloimmunization against fetal platelet (PLT) antigens inherited from the father. A healthy 30-year-old Japanese woman (Hit) gave birth to her second child after an uneventful pregnancy. Nine hours after birth, the infant presented with severe petechiae and a PLT count of 6 x 10(9)/L.

Polymerized structure and improved physical and biochemical material properties of carboxymethyl dextran-conjugated collagen.

Pepsin-solubilized collagen (PSC) was conjugated with carboxymethyl dextran (CMD) using cyanogen bromide to obtain a PSC-CMD film having improved physical properties, physiological properties, and cell affinity. The conjugation was confirmed by the loss of the alpha- and beta-subunit chains and the polymerized band on SDS-PAGE, and by a decrease in the isoelectric point to 3.2.

Soft textural and emulsifiable gelatin formed by conjugating with fatty-acylated saccharide.

Ossein gelatin (OG) and low-molecular-weight ossein gelatin (LOG) were conjugated with a glucose/fructose stearic acid monoester (GE/FE), which had been prepared from the hydrolysate of a sucrose stearic acid diester, by the Maillard reaction to improve their physical properties. The molar ratio of each conjugate (GE/FE-OG or GE/FE-LOG) was about 1:1, and the conjugation resulted in a decreased isoelectric point. The GE/FE-OG gel showed a lower storage modulus, melting temperature, and enthalpy change than those for the OG gel at both the early and late stages of gelation, and each gel at pH 3.

Discrimination of ionic pollutants except condensation nuclei of acid fog using an ultrasonic humidifier.

Fog droplets in the atmosphere are first produced by the activation of cloud condensation nuclei (CCN), which are originally some ionic compound. Subsequently, the nuclei grow by vapor diffusion. Fog droplets are polluted through the activation process and successive diffusion growth and residence (post activation).

Improved physical and biochemical features of a collagen membrane by conjugating with soluble egg shell membrane protein.

Soluble egg shell membrane protein (SEP) prepared from the egg shell membrane by performic acid oxidation and pepsin digestion was applied to prepare a membrane conjugated with pepsin-solubilized collagen (PSC) by cross-linking with water-soluble carbodiimide. SEP enabled a conjugated membrane to be constructed with a well-developed network structure having thicker collagen fibrils and higher stability than the PSC membrane alone, as indicated by reduced solubility and collagenase-digestion, increased denaturation temperature, and superior flexibility. The SEP-PSC membrane (SEP:PSC of 1:1, w/w) had lower sweatiness than the PSC membrane.

Effect of long-range transport of air mass on the ionic components in radiation fog in northern Japan.

Water samples from radiation and upslope types of fog were collected at Takanosu Basin and Hachimantai mountain range of Akita Prefecture in northern Japan, respectively. The effect of the long-range transport of pollutants from the Asian Continent to the basin and the mountain range on the chemical characteristics of two types of fog was studied using chemical analysis data for the water samples as well as the back-trajectories of the air mass. In particular, non-sea-salt (nss)-SO4(2-) of radiation fog provided a much higher concentration than that of upslope fog, which suggests that nss-SO4(2-) might be transported mainly from the Asian Continent.