BACTERIOPHAGES OF AEROMONAS VERONII AND THEIR USE IN CARP AEROMONOSIS

Bacteriophages to Aeromonas veronii were obtained to combat fish aeromonosis. Species specificity of the isolated bacteriophages was shown. Their biological and physical properties, productivity was studied. Primary studies of the therapeutic and prophylactic effectiveness of a biologic product of bacteriophages on yearlings of carps have been carried out

Determining If a Somatic Tumor Mutation Is Targetable and Options for Accessing Targeted Therapies

Targeted cancer therapies are drugs and biologics designed to affect cancer cell growth by blocking or interfering with specific molecular pathways in the cancer cell. Use of targeted agents usually requires verification through molecular testing that the patient’s tumor harbors the molecular biomarker that is the target of the drug or is predictive of treatment benefit. Genomic mutations may be clinically actionable if they are associated with response or resistance to a potential therapy. If a genomic test reveals an actionable alteration, there are several options for accessing the targeted therapy. This article is intended to help clinicians determine if a tumor mutation is potentially treatable with a marketed or investigational drug or biologic product and to offer guidance on how to access the product of interest.

Regulatory aspects for Biologic Product licensing in Australia

The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). Explains the Australian regulatory requirements for supplying of Biologicals Explains what is required for the market authorization as per TGA especially for Biologicals.

Personal cell therapy for interstitial cystitis with autologous stromal vascular fraction stem cells

Background: The objective of this study was to evaluate whether autologous stem-cell-based therapy may mitigate the symptoms of interstitial cystitis. Methods: Stromal vascular fraction (SVF) rich in stem cells and derived from autologous adipose tissue was deployed into 109 men and women with interstitial cystitis/painful bladder syndrome as a surgical procedure. This stem-cell-rich biologic product was injected both systemically and regionally into pelvic floor targets. Patients were queried about quality of life and symptom and bother subjective outcomes tests every 3 months for 2 years. Results: A total of 78 patients reported a positive response at 1 year. Symptom and bother metrics were statistically improved at 1 year. There were minimal adverse events associated with the harvesting, procurement, and clinical deployment of SVF. Conclusion: Interstitial cystitis is a complex clinical problem that is known for its resistance to conventional therapies. SVF as an autologous personalized regenerative strategy shows good safety and efficacy and may potentially have a role in the mitigation of interstitial cystitis.

Biosimilars Have Arrived: Rituximab

A biosimilar is a biologic product that is highly similar to a licensed biologic (“originator”) such that there are no clinically meaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data exclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to the availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential biosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety. Approval of a biosimilar is based upon the totality of the evidence demonstrating similarity to the originator. An understanding of the process of the interchangeable designation of a biosimilar is important in the context of patient outcomes. We conducted an analysis of the properties and benefits of rituximab in the treatment of inflammatory diseases, the development and approval of biosimilars, and the potential benefits of rituximab biosimilars. PubMed and ClinicalTrials.gov databases were searched for “biosimilar” and “rituximab” and regulatory and pharmaceutical company web pages were screened regarding biosimilars in development and specific guidelines developed for the approval of biosimilars. The results indicate that, at present, six rituximab biosimilar candidates are undergoing comparative clinical development, and two were recently approved in the European Union. Our analysis indicates rituximab biosimilars are expected to have a continuing role in treating inflammatory conditions such as rheumatoid arthritis.