Scientific Program

Conference Series LLC Ltd invites all the participants across the globe to attend 25th International Congress on Pharmaceutical Biotechnology Amsterdam, Netherlands.

Day 1 :

Keynote Forum

Shirin Eyvazi

Shahid Beheshti University of Medical sciences, Tehran, Iran

Keynote: Adalimumab Antibody Affinity Maturation: an In Silico Approach
Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Shirin Eyvazi photo
Biography:

Shirin Eyvazi has completed his PhD in field of medical biotechnology from Shahid Beheshti University of Medical Sciences, Tehran, Iran. She is expert in molecular biology techniques and has published more than 12 papers in ISI journals. She teaches molecular biology at university. 

Abstract:

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that occurs in about 5 per 1000 people. Tumor necrosis factor-α (TNF-α) is an inflammatory marker in the inflammatory processes of RA. Therefore, TNF-α might serve as a therapeutic target for the treatment of RA. Adalimumab is a human monoclonal antibody (IgG1) against TNF-α which has been approved by FDA for the treatment of arthritis and other inflammatory related diseases. For a successful immunotherapy the different features of therapeutic antibodies such as binding affinity should be improved. In this regard, we have lunched an in silico approach to increase the affinity of adalimumab to TNF-α. We find the important amino acids of the adalimumab antibody using different software and web servers, and then replaced these amino acids with others to improve antibody binding affinity. Finally, we examined the binding affinity of antibody variants to the antigen using different docking programs. The results indicated that the replaced new amino acids in the binding site of adalimumab increase the affinity of the antibody to TNF-α. In conclusion it should be pointed out that, the employed in silico approach could pave the way for increasing the affinity of antibodies. Increased affinity enhances the biological action of the antibody, which in turn improves the therapeutic effects. Furthermore, the increased antibody affinity can reduce the therapeutic dose of the antibody, resulting in lower toxicity and handling cost.

Keynote Forum

Jean Bruno Mokoko

Brazzaville University Hospital, Faculty of Health Sciences, Marien Ngouabi University, Brazzaville, Congo

Keynote: ANALYSIS OF THE COLD CHAIN IN ROUTINE BRAZZAVILLE VACCINATION
Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Jean Bruno Mokoko photo
Biography:

Jean Bruno Mokoko, Brazzaville University Hospital, Faculty of Health Sciences, Marien Ngouabi University, Brazzaville, Congo.

Abstract:

This Background: respecting the cold chain (CC) is essential in the quality and safety of vaccination. The purpose of this work was to determine the factors influencing the operation of the cold chain.

Methodology: it was a cross-sectional and observational study. The strategy consisted, after random sampling, of conducting a survey of a sample of 91 vaccinating agents from 26 integrated health centers (IHC) distributed in the seven Socio-Sanitary District (SSD) of Brazzaville. The data was collected over an eight-month period based on an individual interview with the agents, observation, examination of the documents of the vaccination unit and the cold chain. These data were recorded on a survey sheet. As a result, the study found that 72% of staff were trained and retrained for the Expanded Program on Immunization, 73% of CSIs had normal refrigerators, and 63% of centers did not have their current temperature records. In the event of refrigerator failure or load shedding, 30.7% of IHC exposed vaccines to inadequate temperatures; 53.8% keep vaccines at the nearest center and 46.2% of centers link vaccines to other products. At 92.3% the source of energy was the current.

 

Keynote Forum

Jean Francois Jenck

Business developer, ALGOLIGHT.

Keynote: AlgoLight, a photobioreactor platform for microalgae-based biopharmaceuticals

Time : 09:30-10:20

Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Jean Francois Jenck photo
Biography:

Jean Francois JENCK has spent 35 years in the fine and petrochemical industries, from R&D to operations and investments. Formerly Technology Counselor of a multinational firm, he refocused to biotechnology and co-founded different start-ups (ENKI Innovation, AlgoSource, AlgoLight).

Abstract:

Microalgae are explored as a next-generation platform to produce biopharmaceuticals. Compared to current methods (mammalian cells, yeast, bacteria), plant-based techniques have the advantages of higher biosynthetic capacity, genetic engineering flexibility, absence of human pathogens, and finally lower cost. Photosynthetic microalgae have been proven at the lab scale to be a viable option for recombinant protein production, due to successful genes expression. On the way to commercialization, process development is now critical.

A process using genetically modified microorganisms must meet the regulatory legislation (UE Directive 2009/41/CE 6 May 2009). The production of microalgae in low-cost open systems can be easily contaminated and cannot avoid the spread of strains into the environment. A containment is possible in closed bioreactors, but the axenic character is not guaranteed, the control of the growth parameters is complex, the poor light distribution (either solar or artificial) is the limiting factor leading to low productivity.

AlgoLight (www.algolight.com), in cooperation with the University of Nantes, has developed a photobioreactor with internal volumetric illumination: PRIAM has a very high specific light area (up to 500 m-1), thus making it extremely productive and compact. The technology is based on a multilayer stack of double-sided light-emitting Lightex® plates, incorporating woven optical fibers fabrics fed by LEDs. The volumic productivity of a fermenter can now be reached in a photosynthetic process.

Opening a way to the cGMP-compliant production of plant-based therapeutic proteins in large-scale systems, our PRIAM photobioreactor is currently being scaled-up into a pre-industrial platform.

Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Shabnam Solati photo
Biography:

Shabnam Solati developed a Monocyte Activation Test to meet all the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to build the future of MAT even beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

Abstract:

For the purposes of primary health care and patient safety, one of the most important characteristics of a pharmaceutical product is purity and being free of pyrogenic contaminations. Vaccines are being tested for the possible side effects due to the pyrogenic contaminants. Pharmaceuticals worldwide are transitioning from the use of the Rabbit Pyrogen Test (RPT) for batch release of parenteral drugs or for risk assessments where Bacterial Endotoxin Tests (e.g. LAL) are used. This is in accordance with revisions made within the European Pharmacopeia, now starting to be enforced for all producers wishing to distribute across Europe. Using Microbiological testing as risk assessment to assure the drug is free of microbial contaminant is not sufficient. These methods are unable to detect microbial components by which the product quality and patient safety is impacted significantly.

Unlike LAL or rFC (solely Endotoxin assays), the MAT is an in vitro pyrogen test that detects both endotoxin and non-endotoxin contaminants. Omitting testing for non-Endotoxin Pyrogens carries significant risks, specifically when biological based products are involved. The proprietary methods we employ in isolating and cryopreserving our PBMCs mean our kits deliver reactivity of fresh blood, highest sensitivity and consistent reproducibility both within and across our large batches of up to 2,000 vials. Using the MAT during COVID-19 vaccine development and manufacturing is an important contribution to ensure human protection based on an effective non-animal based method of quality control.

 

Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Abdulmohsen Alrohaimi       photo
Biography:

Dr. Abdulmohsen H. Alrohaimi has earned his doctorate degree from Tufts University Boston USA in the area of Pharmacogenetics. Back in Saudi Arabia, he joined Saudi Food and Drug Authority (SFDA) as an executive director and established the infrastructure for clinical trial in the kingdom. He contributed to SFDA all his skill and expertise and initiated many educational awareness programs for the community development.  Currently he is holding position of dean in the School of Pharmacy Shaqra University.

Dr. Alrohaimi chairs more than ten scientific and research committees. He has to his credit two books and a good number of research papers in various highly index journals. He has presented many of his research works in several national and international conferences in Saudi Arabia and abroad. His area of interest is Clinical trial, Pharmacovigilance, Pharmacogenetics Biotechnology and Stem cell techniques.

Abstract:

The Coronavirus (COVID-19) has become an issue of international concern, with many countries enforcing total lockdowns on their citizens to combat its spread. The initial cases of this virus are traced in Wuhan, a Chinese city in December 2019. It has, however, spread to numerous countries over the past three months, causing multiple fatalities and strain on countries’ healthcare systems. Statistics reveal that approximately 800,000 cases have been recorded worldwide, with deaths almost reaching the 40,000 mark (New York Times). China, Italy, Spain, and the United States of America have so far recorded the highest numbers of confirmed cases and fatalities. The World Health Organization already declared it a global pandemic due to the numerous risk factors. The infectious nature of the disease has led to healthcare crises, with scientists desperately searching and testing for potential treatment interventions and vaccines.

The search for a cure has led many scientists and virologists to engage in numerous trials to secure the appropriate intervention. Some of these interventions interfere with the recipients’ immune system, resulting in a host of other complications. The testing of the vaccine could also be delayed since its safety and effectiveness must be ascertained before it is rolled out. It is, therefore, imperative to explore other alternatives that are effective with fewer risks on the human body. Firstly, a robust immune system is critical in the treatment and cure for COVID-19. The severity of the disease is proportional to an individual’s immune system, with compromised immunity posing significant challenges. Supplementation with minerals, herbs, and vitamins could improve immunity, helping to prevent the severity of the disease as well as helping with the healing process. Besides, antiviral medication such as remdesivir could also be useful in combating this disease. This drug has been effective in treating virus-related respiratory diseases such as SARS (Campell et al). Its effectiveness is known, and safety guaranteed, hence a milestone in protecting the immunity of COVID-19 patients.

Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Segundo Mesa Castillo photo
Biography:

Segundo Mesa Castillo. As Specialist in Neurology, he worked for 10 years in the Institute of Neurology of Havana, Cuba.  He has worked in Electron Microscopic Studies on Schizophrenia for 32 years. He was awarded with the International Price of the Stanley Foundation Award Program and for the Professional Committee to work as a fellowship position in the Laboratory of the Central Nervous System Studies, National Institute of Neurological Diseases and Stroke under Dr. Joseph Gibbs for a period of 6 months, National Institute of Health, Bethesda, Maryland, Washington D.C. USA, June 5, 1990. 

Abstract:

There is increasing evidences that favor the prenatal beginning of schizophrenia. These evidences point toward intra-uterine environmental factors that act specifically during the second pregnancy trimester producing a direct damage of the brain of the fetus. The current available technology doesn't allow observing what is happening at cellular level since the human brain is not exposed  to a direct analysis in that stage of the life in subjects at high risk of developing schizophrenia. Methods. In 1977 we began a direct electron microscopic research of the brain of fetuses at high risk from schizophrenic mothers in order to finding differences at cellular level in relation to controls. Results. In these studies we have observed within the nuclei of neurons the presence of complete and incomplete viral particles that reacted in positive form with antibodies to herpes simplex hominis type I [HSV1] virus, and mitochondria alterations. Conclusion. The importance of these findings can have practical applications in the prevention of the illness keeping in mind its direct relation to the aetiology and physiopathology of schizophrenia. A study of amniotic fluid cells in women at risk of having a schizophrenic offspring is considered. Of being observed the same alterations that those observed previously in the cells of the brain of the studied foetuses, it would intend to these women in risk of having a schizophrenia descendant, previous information of the results, the voluntary medical interruption of the pregnancy or an early anti HSV1 viral treatment as preventive measure of the later development of the illness.

 

Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Walaa H. El-Maadawy photo
Biography:

Walaa El-Maadawy “Researcher at the Pharmacology Department, Theodor Bilharz Research Institute (TBRI)” has completed her PhD in 2017 from Faculty of Pharmaceutical Sciences, Cairo University in the field of Pharmacology &Toxicology. She is also the Moderator of the Research Ethics Committee, TBRI. Her research work focuses on: pharmacokinetics, bioavailability and bioequivalence studies; investigation of therapeutic approaches for hepatic fibrosis and fatty liver diseases. She has published seven research articles in reputed journals and participated in four research projects sponsored by international and national agencies.

 

Abstract:

Gallic acid (GA), a polyphenolic compound, is reported to possess potent antifibrotic effects in experimental animals, but exhibits low bioavailability due to its rapid clearance. Accordingly, we designed polymeric composite nanoparticles (NPs) as specific targeted delivery system for GA into hepatic stellate cells (HSCs); pivotal cells in orchestrating hepatic fibrogenesis. GA-loaded-NPs were prepared by solvent evaporation technique and characterized by different techniques. Cytotoxicity of GA-loaded-NPs was evaluated in rat HSCs cell line and primary hepatocytes using sulforhodamine B (SRB) assay. We also recorded the uptake of GA-loaded-NPs and their effects on cell migration in activated HSCs. The gene expressions of collagen I (col-1α), transforming growth factor (TGF)-β1 and α-smooth muscle actin (α-SMA) in HSCs were measured using qRT-PCR. Thereafter, bio-distribution of GA-loaded-NPs in rats was monitored via confocal laser scanning microscopy (CLSM). Results revealed that GA-loaded-NPs showed mean Particle size= 230nm, zeta potential= -33mV, polydispersity index= 0.22, encapsulation efficiency= 66 %w/w and in vitro drug release profile with burst release in the first hours followed by a sustained GA release for 24 hours. GA-loaded-NPs were more cytotoxic on HSCs by 80% than free GA solution without showing any cytotoxic effects on hepatocytes. GA-loaded-NPs exhibited enhanced uptake in activated HSCs and inhibition of migration and fibrogenic genes expression of col-1α, TGF-β1and α-SMA in HSCs. Furthermore, CLSM illustrated higher accumulation of GA-loaded-NPs in liver than other organs. This is the first study that clearly shows the efficacy of GA-loaded NPs targeted delivery for HSC as a promising therapeutic approach for liver fibrosis.

Keynote Forum

Felicia Andrei

University of Medicine and Pharmacy Victor Babeș Timișoara, Romania

Keynote: TTYH2- Promising colon cancer treatment development
Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Felicia Andrei photo
Biography:

Felicia Andrei is a PhD in Medicine (Anathomy and Embriology) and a pharmacist specialised in Clinical Pharmacy with two Masters degrees: one in Pharmacy -Formulation and evaluation of the dermatocosmetic product and the other in Polytehnic Computer Automation - Information Systems in Health Care, now Assistant Professor of the Faculty of Pharmacy in Timisoara. Active member in the College of Pharmacists (Romania) and of the European Federation for Pharmaceutical Sciences

Abstract:

Most of the cancers harbor molecular alterations in their genomes. These mutations have not yet been comprehensively explored in the colon cancer. TTYH2, a human homologue of the Drosophila melanogaster gene tweety, is involved in cell proliferation and cell aggregation.The TTYH2 gene may play an important role in regulating both proliferating and metastatic potentials of colorectal cancer. Here we present in the first part a large scale database sequencing study of colon cancer, frecquent in Romania but also in the world. The aim was to demonstrate its power to produce somatic expresions.The tissue specificity of these gene is expressed at higher level in brain and testis and at lower levels in heart, ovary, spleen and peripheral blood leukocytes as well as in the skin. Up-regulated in 13 of 16 renal carcinoma and in 164 total unique samples of colon carcinoma, surgical specimens examined, our results reveal the genetic basis of 180 cases. So we identified and deeply characterized this driver of neocellular changes. These findings broaden our understanding of colon cancers and lead to new diagnostic and therapeutic approaches using TTYH2 antibodies.

Keynote Forum

Kimia Kardani

Department of Hepatitis and AIDS, Pasteur Institute of Iran, Tehran, Iran

Keynote: Enhanced Immunogenicity of MPG/HIV-1 MPER-V3 nanoparticles using prime-boost strategy in BALB/c mice
Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Kimia Kardani photo
Biography:

Kimia Kardani is 27 years old and she is PhD candidate in Pharmaceutical Biotechnology at Shahid Beheshti University of Medical Sciences, Tehran, Iran. She has published five papers in reputed journals and also she is one of the contributors of HPV Infections: Diagnosis, Prevention and Treatment book which has published by Bentham Science Publishers.

 

Abstract:

Due to the global pandemic of human immunodeficiency virus type 1 (HIV-1), expanding research and accelerating HIV-1 vaccine development is a serious importance. To trigger potent and strong humoral and cellular immune responses, efficient and powerful HIV-1 preventive vaccine is needed. It has shown that MPER of gp41 and V3 Loop of gp120 are highly conserved regions and they are great targets of bNAbs. Thus, in order to induce potent immunogenicity, we have used the fusion construct of MPER-V3 along with a DNA delivery system (MPG cell penetrating peptide) and a peptide adjuvant (Montanide 720) in mice. The in vivo analysis was performed in BALB/c mice as three vaccination strategies including DNA/DNA, peptide/peptide, and DNA/ peptide (prime/boost). Our data showed that the MPG/MPER-V3 complexes were formed as stable non-covalent nanoparticles at the N/P ratio of 10:1 with a size of 110-130 nm. The results indicated that MPG and Montanide improved IgG1, IgG2a and IFN-gamma immune responses in mice. These responses were remarkably higher in heterologous prime/boost and then peptide immunization strategies than DNA immunization. Generally, our study demonstrated that delivery of MPER-V3 fusion as DNA/Peptide could be an efficient approach to trigger immune responses as a potent and strong vaccine candidate for HIV-1 infection.

 

Keynote Forum

Priti J Mehta

Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Gujarat, India

Keynote: Biosimilars: Comparative evaluation of Regulatory requirements of selected countries

Time : 15:20-16:00

Euro Pharmaceutical Biotechnology 2020 International Conference Keynote Speaker Priti J Mehta photo
Biography:

Dr. Priti Mehta, Professor of Pharmaceutical Analysis at Institute of Pharmacy, Nirma University, has more than 20 years of teaching, Research and industrial experience. She is pioneer in starting post graduate program of Pharmaceutical Regulatory affairs in Institute of Pharmacy. Her area of expertise encompass stability studies of drugs, Impurity profiling, elucidation of degradation pathways of drugs, isolation and characterization of active moiety from plant and marine seaweeds, bioequivalence and bioavailability studies, development of long acting formulations, effects of radiation exposure on medicines, development of radioprotectors etc. She is pioneer in getting interdisciplinary research grants at Nirma University. Currently Dr Mehta is working on many government funded research projects worth of more than 10 million She is mentor of Women Scientist under WOS-A scheme of DST. Under her guidance many student got research fellowship from CSIR, INSPIRE, ICMR etc. Dr Mehta has published number of research papers and review articles in peer reviewed scientific Journals. Dr. Mehta has delivered guest lectures at various Institutions during seminars, workshops and staff development program. She has rendered professional services to leading Universities at various capacities. Her research students won scientific poster awards at national forums. She is a recipient of many national awards in India. Recently, she conferred prestigious APTI woman of the year 2018 award by Association of Pharmaceutical Teachers of India.

Abstract:

In recent few years, there are many classic Biological products are going off patent which has generated an abridged route for the Biosimilars products which relies on the extensive comparability testing against Reference Biological Products (RBP). A biosimilar demonstrates similarity to the reference biotherapeutics product in terms of quality, safety and efficacy.  Biosimilars are product similar to biologics but not identical.

The generic approach (demonstration of bioequivalence with a reference medicinal product by appropriate BABE studies) which used for most small molecule drugs is in principle not appropriate to biological/biotechnology derived products due to their complexity.

For approval of a biosimilar product, guidelines in various countries provide abbreviated approval pathway involving step-wise comparability exercise of a biosimilar with reference biological product which requires the generation of comparative analytical, non-clinical and clinical data (usually one or two phase I and phase 3 comparative studies). The scientific principles of such a biosimilar comparability exercise are based on those applied for evaluation of the impact of changes in manufacturing process of a biological medicinal product. The amount of data required for biosimilar approval is more than that for generic small molecule chemical product approval and less than that for reference biological product.

EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in USA (2009), Brazil (2010), India (2012) and in China (2015). This article summarizes the regulatory requirements for approval of biosimilars in India, Europe, USA, Brazil, and China.