Biopharma

As pharmaceutical sector is growing so fast, many companies are producing their products and selling throughout the world. So to control the Drug development, licensing, production of drugs and selling many regulatory agencies are established.  There are some international regulatory agencies are available like, ICH (International conference on harmonization), WHO (World health organization), PAHO (PAN Americal health organization), WIPO (World intellectual property organization), WTO (World trade organization). Apart from these many countries are develop their own regulatory body like, USFDA(USA), EMEA( European Union), CDSCO(India), MHRA(UK), TGA(Australia), Health Canada (Canada), ANVISA(Brazil), NMPA(China), MCC(South Africa), NAFDAC(Nigeria), PMDA(Japan), NMRA(Srilanka), KFDA(Korea) etc. Indian Drug Regaulatory Authority DCGI (Drug Controller General of India) - DCGI is the head of CDSCO in India.    CDSCO (Central Drug Standard Control Organization) - Headquarter:-

Clinical trials are set of tests in medical research and drug development that generates safety and efficiency data for health intervention in human beings. Clinical trials are the part of drug development process. Drug development include the steps like,  (1) Preclinical test,  (2) IND (investigation new drug) Application filling, Review and approval,  (3) Clinical Trials  (4) NDA (New drug application filling and approval),  (5) Post marketing. Applicant before going to clinical trials, one need to complete preclinical on Cell line and Animal, (in vivo/in vitro) test.  Main evaluation phases in preclinical test are, Pharmacodynamic, Pharmacokinetic, Toxicity profile, Safety and efficiency. After successful completion of preclinical tests, applicant has to file for IND approval. Once IND approval being done then clinical trial can start. CLINICAL TRIAL:-  Clinical trial have five phases from phases 0 to phase IV. Phase 0:-  In phase 0 study of drug at micro dosing (1/100 of the dose o

Filter integrity testing methods are classified in two types,  1) Destructive test 2) Non destructive test The goal of filter integrity test is to ensure product quality, product performance and reduce the risk. Filter or filtration membrane are made up of PTFE (polytetrafluoroethylene) or PVDF (polyvinylidene fluoride), PTFE is more hydrophobic than PVDF. Destructive test is generally performed by manufacturer based on statistical sample from each lot of membrane and fabricated devices produced. Non destructive testing perform by manufacturer on each sterilizing grade filter prior to sale to ensure it's integrity. (Ref. Merk Millipore. Com "Integrity Testing methods".) The product deliver to end user are integrity tested but once the product exit from manufacturing company there will be a chance of damage during shipment/supply to end user so it's preferred to perform pre and post use integrity by the end user to ensure product integrity. 1) Destructive filter integ

E.COLI (Escherichia Coli) Discovery/History It was discovered in 1885 by German bacteriologist Theodor Escherich (Dr. Escherich) in human colon hence it called coli. Initially it was called "Bacterium Coli" latter it changed to Escherichia Coli to honor of its discover. More than 700 serotype of E Coli have been identified. The 'O' and 'H' antigens on the bacteria and their flagella distinguish the different serotype. The useful or harmless strain are the part of normal microbiota of gut, they produces vitamin K2 and helpful in prevention of colonization of pathogenic strain in intestine.    The O157:H7 is the pathogenic strain and was first recognize on 1982. This strain relentlessly evolving organism, constantly mutating and aquaring new characteristics. Biological Classification  Domain : Bacteria (Domain designed by Carl Woese, three domains Archaea, Bacteria and Eukarya) Kingdom: Bacteria (Six kingdom -Archaebacteria, Eubacteria,

  CORONA VIRUS: - Corona virus was discovered in 1960s. The thought at that time, they are responsible for mild disease of respiratory and intestinal infections in animals and humans with strain HCoV 229E and HCoV OC43. That change in 2003 as SARS ( Pandemic) and in 2012 as MERS {Ref ncbi.nlm.nih.gov} - Seven of this viruses can infect the people: (1) 229E (2) NL63 (3) OC43 (4) HKU1 (5) MERS-CoV (6) SARS-CoV (7) SARS-CoV-2, COVID-19.   {Ref webmd.com} VIRUS LIFECYCLE and Drug Target : As shows in above figure virus enter into the cells and goes to different stages of life cycle and come outs by exocytosis. DRUGS: Direct Acting: 1) Hydroxychlorouine (HCQ): In 1956 USFDA approved HCQ for symptoms lupus and rheumatoid arthritis. (Ref Lupus.org) During first wave of SARS-CoV-2, HCQ got the emergency use authorization for this disease but after solidarity trial (international clinical trials) it found ineffective. (Ref  WHO) HCQ acts by suppressing Toll-like receptors to trigger important i

Bacterial Inclusion Body (IB) ·          Inclusion body (IBs) are partially folded protein aggregate. When level of expression of protein goes beyond 2% of the total cellular proteins it leads to formation of inclusion body. It  contains mostly single type   polypeptides and very little amount of host protein components, DNA and RNA fragments. ·         IBs are found in cytoplasm, if secretion signal used it can produces in periplasm also. ·         IBs are formed due to overexpression of heterologous protein, which are unable to solubilize in  cytoplasm and form aggregates.           ·         Bacterial cytoplasm having reduced environment hence di-sulfide bonds of proteins are not formed and proteins remain unfolded/partial folded.     ·         Protein in IBs have native like secondary structure. Proteins i n IBs are aggregated by ionic and hydrophobic interaction. ·          IBs reflect light so it can be visualized by phase contrast microscopy. ·