Pharmacotherapeutics of Biotechnology-Derived Products

1998 ◽  
Vol 11 (1) ◽  
pp. 54-71
Author(s):  
Peggy Bush
Keyword(s):  
Gene Therapy ◽  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Small Molecules ◽  
Orphan Drug ◽  
Recombinant Proteins ◽  
Human Disease ◽  
Drug Status ◽  
Small Patient ◽  
Biotechnology Products

Biotechnology has contributed to important advances in the healthcare field. Products include various hormones, enzymes, cytokines, vaccines, and monoclonal antibodies, with use in diverse therapeutic areas. The majority of approved biotechnology-derived therapeutic products are recombinant proteins. Many have orphan drug status and, therefore, are used in relatively small patient populations. Newer generation biotechnology products are likely to include small molecules, gene therapy products, and increased numbers of vaccines and monoclonal antibody products. Biotechnology provides the means to develop diverse, innovative, and effective approaches to the prevention, treatment, and cure of human disease.

scholarly journals Monoclonal antibodies used for management of hematological disorders

2021 ◽  
Vol 1 ◽  
pp. 12-21
Author(s):  
Kanjaksha Ghosh ◽  
Kinjalka Ghosh
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Small Molecules ◽  
Chemotherapeutic Agents ◽  
Hematological Disorders ◽  
Scopus Database ◽  
Improved Function ◽  
Benign Disorders ◽  
Dosage Frequency ◽  
Organ Dysfunctions

Objectives: Monoclonal antibodies (MAs) are increasingly becoming part of therapeutic armamentarium for hematologists and hemato-oncologists. There is paucity of review on majority of these antibodies in one place. The objective of this review is an attempt to fill the gap in paucity of review on majority of these monoclonal antibodies (MAs) in one place. Material and Methods: ‘Pubmed’ and ‘Scopus’ database was explored focusing on monoclonal antibodies (MAs) in clinical hematological practice. Emphasis was given to the more recently published review articles on different monoclonal antibodies (MAs). Results: In the present review, a total of 23 different monoclonal antibodies (MAs) were discussed; some are very frequently used and some rarely. Monoclonal antibodies (MAs) are used for treatment of diverse hematological conditions, i.e. malignant and benign disorders and at various phases of stem cell transplantation. These antibodies were used either alone or in combination with various chemotherapeutic agents, targeted small molecules or as immunoconjugates. Some of the side effect profiles of these antibodies were common and some were unique to the particular monoclonal antibody (MA). Unusual infections or organ dysfunctions were noted. Improved function of antibodies by protein engineering is also advancing rapidly. Dosage, frequency and route of administration depended on the convenience and condition for which the antibody is used. Conclusion: Monoclonal antibodies (MAs) are going to stay for hematological practice. Some amount of familiarity with their usage, advantages, disadvantages and side effects are essential in clinical practice.

NIH assistance for new therapeutic development: NIH-RAID Pilot Program

2009 ◽  
Vol 15 (1) ◽  
Author(s):  
David G Badman
Keyword(s):  
Gene Therapy ◽  
Monoclonal Antibodies ◽  
Natural Product ◽  
Small Molecule ◽  
Recombinant Proteins ◽  
Therapeutic Agents ◽  
Preclinical Development ◽  
Non Profit ◽  
Data Services ◽  
Therapeutic Development

The National Institutes of Health (NIH) wishes to alert the biotech/medical research community to an opportunity to obtain assistance in the development of new therapeutic agents. The NIH Roadmap has established a pilot programme, the NIH-Rapid Access to Interventional Development (RAID) Pilot, to make available, on a competitive basis, critical resources needed for the development of new small-molecule or natural product-derived therapeutic agents. This programme, part of the Translational Research component of Reengineering the Clinical Research Enterprise, uses resources of NCI's Developmental Therapeutics Program. Services provided depend upon the project and strength of the preliminary data. Services potentially available include bulk supply, GMP manufacturing, formulation, assay development suitable for pharmacokinetic testing, and animal toxicology. Assistance can also be provided in the regulatory process. Currently, animal efficacy studies and synthesis of recombinant proteins, monoclonal antibodies, or reagents for gene therapy are not supported. The NIH-RAID Pilot will, however, consider requests for services to support later-stage preclinical development of monoclonal antibodies, recombinant proteins, and gene therapy agents. Additionally, the NIH-RAID Pilot will now consider requests for the manufacture of small-molecule or natural product material for any clinical study. Proposals must originate from academic or non-profit investigators, but collaboration with industry partners is encouraged.

Neues aus der Pharmakotherapie

2010 ◽  
Vol 29 (04) ◽  
pp. 191-198
Author(s):  
G. Kluger ◽  
S. Arnold
Keyword(s):  
Orphan Drug ◽  
Orphan Drug Status ◽  
Drug Status

ZusammenfassungRund ein Drittel aller Patienten mit fokaler Epilepsie ist trotz medikamentöser Behandlung nicht anfallsfrei (1). Insbesondere für diese Patienten mit schwer behandelbaren Epilepsien bieten medikamentöse Neuentwicklungen neue Chancen. Seit 2008 steht in Deutschland für Patienten mit fokaler Epilepsie mit Lacosamid ein Wirkstoff mit einem neuen Wirkungsmechanismus zur Verfügung. 2009 wurde die Medikamentenpalette um Eslicarbazepinacetat erweitert. Beide Substanzen haben in großen randomisierten Doppelblindstudien eine signifikante Reduktion der Anfallshäufigkeit im Vergleich zu Placebo belegen können. Zur Behandlung seltener Erkrankungen können Substanzen mit der Option des “Orphan- Drug”-Status auch nach Untersuchung vergleichsweise geringer Patientenzahlen unter besonderen Auflagen zur Verfügung gestellt werden. Als “Orphan Drug” zur Zusatzbehandlung des Lennox-Gastaut-Syndroms wurde 2007 Rufinamid von der EMEA zugelassen. Bereits seit 2001 ist Stiripentol als “Orphan Drug” von der EMEA zur Zusatzbehandlung des Dravet-Syndromes ausgewiesen und seit 2007 als “Orphan Drug” mit Auflagen für Europa zugelassen. 2008 konnte Stiripentol auch in Deutschland eingeführt werden. In dieser Übersicht sollen die wesentlichen Merkmale der genannten Substanzen dargestellt werden.Da selten auftretende Nebenwirkungen nach der Markteinführung einer Substanz auftreten können, sind weitere Untersuchungen notwendig,um die langfristige Sicherheit der vorgestellten Substanzen zu überprüfen.

Rapid quantification and in situ detection of nitrifying bacteria in biofilms by monoclonal antibody method

2000 ◽  
Vol 41 (4-5) ◽  
pp. 301-308 ◽  
Author(s):  
N. Noda ◽  
H. Ikuta ◽  
Y. Ebie ◽  
A. Hirata ◽  
S. Tsuneda ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Fluorescent Antibody ◽  
Nitrifying Bacteria ◽  
Fluorescent Antibody Technique ◽  
Antibody Technique ◽  
Antibody Method ◽  
In Situ Detection ◽  
Rapid Quantification

Fluorescent antibody technique by the monoclonal antibody method is very useful and helpful for the rapid quantification and in situ detection of the specific bacteria like nitrifiers in a mixed baxterial habitat such as a biofilm. In this study, twelve monoclonal antibodies against Nitrosomonas europaea (IFO14298) and sixteen against Nitrobacter winogradskyi (IFO14297) were raised from splenocytes of mice (BALB/c). It was found that these antibodies exhibited little cross reactivity against various kinds of heterotrophic bacteria. The direct cell count method using monoclonal antibodies could exactly detect and rapidly quantify N. europaea and N. winogradskyi. Moreover, the distribution of N. europaea and N. winogradskyi in a biofilm could be examined by in situ fluorescent antibody technique. It was shown that most of N. winogradskyi existed near the surface part and most of N. europaea existed at the inner part of the polyethylene glycol (PEG) gel pellet, which had entrapped activated sludge and used in a landfill leachate treatment reactor. It was suggested that this monoclonal antibody method was utilized for estimating and controlling the population of nitrifying bacteria as a quick and favorable tool.

Therapeutic Monoclonal Antibodies in Clinical Practice against Cancer

2020 ◽  
Vol 20 (16) ◽  
pp. 1895-1907
Author(s):  
Navgeet Kaur ◽  
Anju Goyal ◽  
Rakesh K. Sindhu
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Clinical Practice ◽  
Therapeutic Agent ◽  
Hematologic Malignancies ◽  
Immune Checkpoints ◽  
Malignant Cells ◽  
Main Target ◽  
Therapeutic Monoclonal Antibodies ◽  
Cancerous Cells

The importance of monoclonal antibodies in oncology has increased drastically following the discovery of Milstein and Kohler. Since the first approval of the monoclonal antibody, i.e. Rituximab in 1997 by the FDA, there was a decline in further applications but this number has significantly increased over the last three decades for various therapeutic applications due to the lesser side effects in comparison to the traditional chemotherapy methods. Presently, numerous monoclonal antibodies have been approved and many are in queue for approval as a strong therapeutic agent for treating hematologic malignancies and solid tumors. The main target checkpoints for the monoclonal antibodies against cancer cells include EGFR, VEGF, CD and tyrosine kinase which are overexpressed in malignant cells. Other immune checkpoints like CTLA-4, PD-1 and PD-1 receptors targeted by the recently developed antibodies increase the capability of the immune system in destroying the cancerous cells. Here, in this review, the mechanism of action, uses and target points of the approved mAbs against cancer have been summarized.

Evaluation of the Efficiency of Protein A Affinity Chromatography to Purify a Monoclonal Antibody for Cancer Treatment and its Purity Analysis

2020 ◽  
Vol 7 (2) ◽  
pp. 121-133
Author(s):  
Ayesha Akhtar ◽  
Shivakumar Arumugam ◽  
Shoaib Alam
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Affinity Chromatography ◽  
Protein A ◽  
Exchange Chromatography ◽  
Size Exclusion ◽  
High Yield ◽  
Staphylococcal Protein A ◽  
Purification Step ◽  
Purity Analysis

Background:: Protein A affinity chromatography is often employed as the most crucial purification step for monoclonal antibodies to achieve high yield with purity and throughput requirements. Introduction:: Protein A, also known as Staphylococcal protein A (SPA) is found in the cell wall of the bacteria staphylococcus aureus. It is one of the first discovered immunoglobulin binding molecules and has been extensively studied since the past few decades. The efficiency of Protein A affinity chromatography to purify a recombinant monoclonal antibody in a cell culture sample has been evaluated, which removes 99.0% of feed stream impurities. Materials and Method:: We have systematically evaluated the purification performance by using a battery of analytical methods SDS-PAGE (non-reduced and reduced sample), Cation Exchange Chromatography (CEX), Size-exclusion chromatography (SEC), and Reversed phased-Reduced Chromatography for a CHO-derived monoclonal antibody. Results and Discussion:: The analytical test was conducted to determine the impurity parameter, Host Cell Contaminating Proteins (HCP). It was evaluated to be 0.015ng/ml after the purification step; while initially, it was found to be 24.431ng/ml. Conclusion:: The tests showed a distinct decrease in the level of different impurities after the chromatography step. It can be concluded that Protein A chromatography is an efficient step in the purification of monoclonal antibodies.

scholarly journals Development of a New Highly Selective Monoclonal Antibody against Preferentially Expressed Antigen in Melanoma (PRAME) and Identification of the Target Epitope by Bio-Layer Interferometry

2021 ◽  
Vol 22 (6) ◽  
pp. 3166
Author(s):  
Jwala Priyadarsini Sivaccumar ◽  
Antonio Leonardi ◽  
Emanuela Iaccarino ◽  
Giusy Corvino ◽  
Luca Sanguigno ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Western Blotting ◽  
Cancer Biomarkers ◽  
Trypsin Digestion ◽  
Protein Fragments ◽  
Target Epitope ◽  
Potential Activity ◽  
Antibody Epitopes

Background: Monoclonal antibodies (mAbs) against cancer biomarkers are key reagents in diagnosis and therapy. One such relevant biomarker is a preferentially expressed antigen in melanoma (PRAME) that is selectively expressed in many tumors. Knowing mAb’s epitope is of utmost importance for understanding the potential activity and therapeutic prospective of the reagents. Methods: We generated a mAb against PRAME immunizing mice with PRAME fragment 161–415; the affinity of the antibody for the protein was evaluated by ELISA and SPR, and its ability to detect the protein in cells was probed by cytofluorimetry and Western blotting experiments. The antibody epitope was identified immobilizing the mAb on bio-layer interferometry (BLI) sensor chip, capturing protein fragments obtained following trypsin digestion and performing mass spectrometry analyses. Results: A mAb against PRAME with an affinity of 35 pM was obtained and characterized. Its epitope on PRAME was localized on residues 202–212, taking advantage of the low volumes and lack of fluidics underlying the BLI settings. Conclusions: The new anti-PRAME mAb recognizes the folded protein on the surface of cell membranes suggesting that the antibody’s epitope is well exposed. BLI sensor chips can be used to identify antibody epitopes.

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