生物分析与生物医学杂志

Biosimilar Act, passed in 2007 under 351(k), states that a biosimilar product should be “highly similar” to prior approved reference product (RLD) and will have “no clinically meaningful differences” in their safety or efficacy. FDA also published three guidances to support this biosimilar project. However, the biosimilar processes are not so smooth. The biological molecules, manufacturing processes, and impurities profiles are complex; leaving various issues in deriving different sections of CMC work. Due to relative complexities in producing biosimilar product small differences in the design and execution of manufacturing process can have a large influence of product related-, process related-,or host related impurities protein profile of a finished product, which may trigger immunogenicity and changes the clinical profile requiring elaborate animal studies and human clinical studies. FDA’s guidance is not very clear to drive the product into regulatory pathway for approval. Complexities still exist in clinical studies as clinicians like to review the details of data from three phase 3 trials and payors wish to see more stringent data regarding safety and efficacy. However, EMA developed a centralized path for the approval of Biosimilar product and so far EMA approved 16 products. One of the remedies is that if the biosimilar product is purified to homogeneity or near homogeneity, and if it is stabilized and restores the functional activities, the impurities protein content will be negligible or minimum, which may not trigger the immunogenicityor other clinical issues. With more advancement of science, research and development may solve these issues and open the easier regulatory pathway for biosimilar approval. Interchangeability and price reduction issues may be solved at that time.

Background: Niche plays an important role in deciding the fate of the cell. Three dimensional (3-D) cell culture systems can provide conditions for the cells to revert back to de-differentiated state. Here, egg white is used as a scaffold as well as nutritive medium for the 3-D culture, as it provides nutrients for the cells to grow without extra media. In order to compare the growth of spheroids, another model was also taken into account that is gelatin coated plate. The difference between these two models was that the egg white acted as scaffold and provided additional nutrients for the growth of spheroids, while gelatin provided conditions for low attachment only. Method: Low attachment plates were prepared using egg white and gelatin for the spheroids to grow on it. RNA from cells grown on both 2D and 3D culture condition were extracted using trizol method. The concentration of RNA was determined by repeated OD measurements of aliquots at a wavelength of 260 nm and c-DNA was constructed using Fermentas kit. Finally, gene expressions were checked by PCR using thermo cycler. Conclusion: The cells had grown into spheroids on egg white based plate rather than gelatin coated plate. Gene expression was found to be upregulated in cells grown on egg white. Thus, it was proved that the niche provided by the egg white has induced de-differentiation, which leads to the acquisition of a stem cell like properties.

This overview describes the optimal implementation and utilization of different, newly conceived nanosensors for human biosafety purposes, exploiting a variety of methods (amperometric, conductometric, spectrometric and nanogravimetric), and a wide range of nanocomposites, genes and recombinant enzymes. Namely, while biological nanosensors were designed based on Nucleic Acid Programmable Protein Arrays (NAPPA), with or without SNAPtag, and on Langmuir-Blodgett (LB) thin films of recombinant laccase (Rigidoporus lignosus, formerly known as Rigidoporus microporus), organic nanosensors were based on matrices of calcium oxide (CaO) and on carbon nanotubes–either multi-walled (MWNTs) or single-walled (SWNTs)– embedded in poly(o-methylaniline) (POTO). Special attention was paid both to detecting useful and relevant substances (such as carbon dioxide, phenols and phenolic derivatives and compounds) and designing devices and molecules for human biosafety like vaccines and others, by means of amperometry, conductimetry, mass spectrometry (MS) and other label-free technologies, such as quartz crystal microbalance with dissipation monitoring (QCM_D).

The burden of inherited diseases in terms of congenital defects and cancer predisposition in addition to a multitude of neurological, cardiovascular and other organ diseases arising sporadically during life is enormous on the individual, immediate family and society globally. I approach this major burden to human society by invoking the powerful technology behind read-through, whereby disease-causing substitution nonsense mutations, oftentimes at the root of human diseases, are rescued. Further, the importance of nonsense mutations in the realm of developmental factors linked to cancer stem cell maintenance is presented. The methodology behind the technique is given and proof of concept behind its use ex vivo and in clinical trials. The discovery of a novel read-through drug, Amlexanox, which has been in use for over twenty years in dentistry for oral ulcerations, represents a next generation read-through agent. This agent has been demonstrated in cell lines to correct functional loss in cystic fibrosis CFTR, dystrophin and the tumour suppressor, p53. Its novel ability to inhibit nonsense mediated decay is discussed. Amlexanox is therefore presently ready for testing in a wide variety of in vivo models of human diseases and also in clinical trials. Given the safety profile of Amlexanox and ex vivo efficacy in studies thus far it is envisaged that this accepted medication shall successfully debut as an all-purpose agent for the prevention and management of human diseases.

An annual sum of approximately £2.8 billion is spent on academic medical research in the UK – £1.2 billion of which is sourced from medical charities. Despite only being a fraction of the amount spent on medical research in the US, the UK is second only to the US in terms of research output, with more articles and citations per researcher than any other country. But how much research with a medical aim is actually converted into a benefit for patients? Is it all money well spent? These are the questions being asked as we endure an economic downturn, while patients seek the next miracle cure.

Totally 11 minerals were reported in the present study. There are about 7 (Sodium>Potassium>Magnesium>Calcium>Manganese>Iron>Zinc) minerals were reported in all sexes. Sodium was maximum and zinc was minimum in all sexes. Copper, mercury and cadmium were available in trace amount in all sexes. However, arsenic was in trace amount in berried females and totally absent in males and females. Among different sexes, berried females contain maximum amount of minerals (157.65 mg) followed by males (117.30 mg) and females (93.65 mg). From the study, berried females contains maximum amount of minerals than males and females. So it is recommended to consume berried females to get maximum minerals.