Biotechnological Substances Research Articles

IVFarma LLC in cooperation with Zavod Medsintez LLC extend production of biotechnological drugs for infertility treatment

On November 19, 2022, the production facility manufacturing of biotechnological substances for women's reproductive health was opened at the Zavod Medsintez LLC in Novouralsk. In 2018, Zavod Medsintez LLC, together with IVFarma LLC, has launched industrial-scale operation of the first Russian follicle-stimulating hormone (FSH) drug Primapur® for infertility treatment within the framework of in vitro fertilization (IVF) protocol. Primapur® shows high efficiency, safety and quality not inferior to international analogues. The launch of the new department will substantially increase the capacity and production scale not only of Primapur®, but also other Russian medicines for reproductive health. Moreover, it is also able to provide a decent import substitution and access to world markets.

Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*

Purpose: Biotechnological substances (BSs) are strongly relied upon to prevent rejection of transplanted organs, and to treat oncological, allergological, and other inflammatory diseases. Allergic reactions to partly foreign biologics can occur due to their potential immunogenicity. The severity of an immune response to a biological drug may range from no clinical significance to a severe, life-threatening anaphylactic reaction.Methods: Detailed searches were performed on Pubmed, Web of Science, and Google Scholar to include all available publications. In addition, the Food and Drug Administration, the European Medicines Agency, and British Columbia Cancer Agency Drug Manual databases were screened for hypersensitivity reaction (HSR), infusion reaction, injection site reaction, urticaria, and anaphylaxis for individual BSs.Results: Treatment with BSs can cause various types of HSR. These are mentioned in the literature with definitions such as allergic reactions, anaphylactoid reactions, anaphylaxis, HSR, infusion reactions, injection site reactions, cytokine release syndrome, and urticaria. Due to the overlap in signs and symptoms in the reported descriptions, it is not always possible to differentiate these reactions properly according to their pathomechanism. Similarly, many data reported as anaphylaxis actually describe severe anaphylactic reactions (grades III or IV).Conclusion: There is an urgent need for a simpler symptom- or system-based classification and scoring system to create an awareness for HSRs to BSs. A better understanding of the pathophysiology of HSRs and increased clinical experience in the treatment of side effects will provide timely control of unexpected reactions. As a result, immunotherapy with BSs will become safer in the future.Cite this as Gülsen A, Wedi B, Jappe U. Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events. Allergo J Int 2020; 29:97-125https://doi.org/10.1007/s40629-020-00126-6.

Screening for Hydrolytic Enzyme Production by Thermophilic Microbes Isolated from Egyptian Hot Spring

Extreme environments like thermal springs are of considerable value as a source of thermophilic microbes, enzymes and biotechnological substances. The hot spring of Ras-Sedr is one of the Egyptian hot springs which not discovered yet. This research was carried out to isolate and screen thermophilic microbes that have the capability to produce thermostable enzymes. The sources for microbial isolation were sediment and water samples, collected from Ras-Sedr's hot spring, Ras-Sedr, Egypt. Three different medium types were used for microbial isolation. The isolates obtained were subjected for enzymatical activity. Three different enzymes, cellulase, lipase and ά-amylase, were selected to be screened by isolated strains. For cellulase activity testing, carboxy methylcellulose (CMC) agar was used as growth medium whereas tributyrin agar medium was used for lipase enzyme, while, starch agar plates were used for amylase enzyme screening. Our results showed that sediment sample harbored higher count of microbes than the water sample. Similarly, ATCC medium recorded higher thermophilic microbial count compared to the other two media used. The isolates obtained also reported a positive activity for all enzymes tested. Therefore, these promising isolates could be a source for pharmaceuticals and industrial applications.

Cyclodextrin⁻Drug Inclusion Complexes: In Vivo and In Vitro Approaches.

This review aims to provide a critical review of the biological performance of natural and synthetic substances complexed with cyclodextrins, highlighting: (i) inclusion complexes with cyclodextrins and their biological studies in vitro and in vivo; (ii) Evaluation and comparison of the bioactive efficacy of complexed and non-complexed substances; (iii) Chemical and biological performance tests of inclusion complexes, aimed at the development of new pharmaceutical products. Based on the evidence presented in the review, it is clear that cyclodextrins play a vital role in the development of inclusion complexes which promote improvements in the chemical and biological properties of the complexed active principles, as well as providing improved solubility and aqueous stability. Although the literature shows the importance of their ability to help produce innovative biotechnological substances, we still need more studies to develop and expand their therapeutic properties. It is, therefore, very important to gather together evidence of the effectiveness of inclusion complexes with cyclodextrins in order to facilitate a better understanding of research on this topic and encourage further studies.

A A review of bioactive compounds produced by endophytic fungi associated with medicinal plants

Interest in exploring endophytic fungi has increased in recent years, especially those associated with medicinal plants, reflecting the great potential of these microorganisms for the production of bioactive substances. Medicinal plants shelter a high diversity of endophytes that represent targets for use in biotechnological processes. These fungi synthetize several compounds that can be used in pharmaceutical, agricultural and other industries. Additionally, endophytes produce many bioactive metabolites involved in host-endophyte symbiosis, such as those that increase resistance to stressful conditions, alter physiological properties, and produce phytohormones, toxins, antimicrobial compounds and medicinal substances, immunosuppressants, antitumoral agents, and other biotechnological substances of interest, such as enzymes. In this review, information regarding plant interactions with endophytes is highlighted, contributing to a better understanding of this association, benefits and potential for biotechnological utilization.

Medicinal Product Regulation: Portugal׳s Framework

PurposeThe pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). MethodsFrom the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. FindingsIn 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients’ safety. ImplicationsThe Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances.

Selection and Use of Poly Ethylene Glycol and Phosphate Based Aqueous Two-Phase Systems for the Separation of Proteins by Centrifugal Partition Chromatography

For an efficient separation with centrifugal partition chromatography (CPC) the selection of suitable biphasic phase systems is of crucial importance. Commonly, aqueous-organic systems have been widely used for the separation of natural products. Thus, a lot of knowledge about the selection of suitable systems and appropriate operation conditions of CPC is available. Alternatively, aqueous two-phase systems (ATPS) can be used in CPC. These systems offer the possibility to purify biotechnological substances like proteins. However, the selection and use of ATPS in CPC and accordingly the selection of appropriate operation conditions have rarely been investigated. In order to improve the knowledge, the focus of this research is on the selection of suitable ATPS and operation conditions for an efficient separation of biomolecules in CPC. Several systems, based on polyethylene glycol and phosphate salts have found to be suitable for use in CPC. Thereby, the hydrodynamic in the chamber is of major importance because it determines the stability and the performance during the separation run. An additional important aspect within the ATPS selection is the possibility to adjust the partition coefficient of the target compounds. This was achieved by changing the pH value of the system. Both aspects, hydrodynamic and adjustment of the partition coefficients were investigated in this study and the results obtained will help to select suitable ATPS and operating conditions for CPC separation of biomolecules.

Equivalence, Similarity, Comparability, and Inter-Changeability of Pharmaceuticals: The Difficult way to Their Practical Application in Italy

Arising with the launch of generic drugs into the pharmaceutical market, the issue of the equivalence among drugs has grown in the course of time, expanding from chemical to biological and biotechnological substances. Far from being a merely academic topic, it implies a tangible clash of interests between providers (the industry) and buyers (public and private health care agencies) of an ever growing number of products. Regional, national and international regulations and laws are piling up, together with some confusion in such a complicated matter. This article aims to bring some clarity, starting from the terms used.

Relevance of microbial coculture fermentations in biotechnology

The purpose of this article is to review coculture fermentations in industrial biotechnology. Examples for the advantageous utilization of cocultures instead of single cultivations include the production of bulk chemicals, enzymes, food additives, antimicrobial substances and microbial fuel cells. Coculture fermentations may result in increased yield, improved control of product qualities and the possibility of utilizing cheaper substrates. Cocultivation of different micro-organisms may also help to identify and develop new biotechnological substances. The relevance of coculture fermentations and the potential of improving existing processes as well as the production of new chemical compounds in industrial biotechnology are pointed out here by means of more than 35 examples.

Removal of Some Carboxylic Acids from Aqueous Solutions by Hydrogels

Carboxylic acids are biotechnological substances that are used extensively in many industries, thus production and separation of carboxylic acids from product mixtures are important scientific and economic problems. The aim of this work was to investigate the removal of acetic, citric, lactic, and tartaric acids from aqueous solutions. With this aim, first the effects of time, temperature, and mixing on separation of the carboxylic acids from aqueous solutions were investigated by experimental work. After the experimental conditions were determined, separation was undertaken for different initial acid concentrations at constant hydrogel concentration. The effect of different gel-acid mass ratios on adsorption at constant initial acid concentrations was determined. The removal of acetic acid was 59.74 %, of lactic acid was 55.45 %, of citric acid was 54.22 %, and of tartaric acid was 56.85 % with a 1.5 hydrogel/acid mass ratio at the lowest concentration of each acid. Results obtained from the experimental work have been used with the Freundlich isotherm.

System Theoretical Considerations of High Pressure Treatment of Biotechnological Substances

System Theoretical Considerations of High Pressure Treatment of Biotechnological Substances