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    Add as FriendBCG VACCINE

    by: SHRAVAN

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    1 : PRESENTED BY:- SHRAVAN PASWAN paswanshravan@gmail.com BCG VACCINE ADVANCE INSTITUTE OF BIOTECH & PARAMEDICAL SCIENCES,KANPUR
    2 : BCG VACCINE The BCG vaccine (Bacillus Calmette-Guerin) was introduced into the UK in 1953. Robert Koch first distinguished Mycobacterium bovis from Mycobacterium tuberculosis. BCG Vaccine is :- Live Freeze-dried Vaccine Conjugate vaccines (conjugate of suitable toxoids with a tuberculosis cell wall saccharide ) Composition & Reconstitution :- Each 0.1 ml contains between: 1x105 and 33x105 C.F.U Reconstitute with Sodium Chloride Injection. Dose: 0.05 ml, intradermally for infants under one year old. Route :- Intradermal
    3 : Injection Technique:- The skin is stretched between thumb and forefinger and sterile needle (25 G or 26 G) inserted bevel upwards for about 2mm into superficial layers of the dermis. Storage:- BCG (Freeze-dried) should be stored in dark between 2°C & 8°C. It is stable if stored in temperatures as low as -20°C. Protect from light. The diluents should not be frozen, but should be kept cool. Shelf Life:- 24 months Role of BCG in tuberculosis control:- Treatment of tuberculin infection. BCG vaccines affords sustained immunity in man.
    4 : 2. EFFECT OF BCG AFTER ADMINISTRATION Table:-1
    5 : 3. GMP REGULATIONS OF BCG VACCINE 3.1 (SUBPART-A) GENERAL PROVISION FINISHED PRODUCT
    6 : 3.2 (SUBPART-B) PERSONNEL All personnel (including those concerned with cleaning, maintenance or quality control) employed in areas where biological medicinal products are manufactured should receive additional training specific to the products manufactured and to their work. Personnel should be given relevant information and training in hygiene and microbiology. The immunological status of personnel may have to be taken into consideration for product safety. All personnel engaged in production, maintenance, testing and animal care (and inspectors) should be vaccinated where necessary with appropriate specific vaccines and have regular health checks.  
    7 : 3.3 (SUBPART-C) BUILDING & PREMISES Approximately 23,000 sqft of manufacturing areas including: Master Cell Bank (MCB) Cell Culture Expansion / Inoculation Cell Culture Harvest Filtration Chemical Inactivation Ultrafiltration Buffer Formulation Downstream Processing 3.4 (SUBPART-D) LIST OF EQUIPMENTS Freeze Driers Autoclaves Clean room facility at Class 10,000 level. Laminar Flow Benches at Class 100 level. Vial filling & vial capping machines.
    8 : EQUIPMENTS USED IN BCG MANUFACTURING FREEZE DRYER SPRAY DRYER INCUBATOR AUTOCLAVE PILOT SCALE HOT PLATE Fig 1: Respective photographs of equipments used in BCG production
    9 : 3.5 (SUBPART-E) LIST OF RAW MATERIAL The concentration of the reconstituted vaccine is 8 x 105 to 32 x 105 colony forming units (CFU) per adult dose of 0.1 mL (= 0.1 mg BCG), equivalent to 4 x 105 to 16 x 105 CFU per infant dose of 0.05 mL (= 0.05 mg BCG). Table2: Required raw materials 3.6 (SUBPART-F) PRODUCTION & CONTROL OF BCG VACCINE Synthetic liquid medium (Sauton medium) subculturing every 2 weeks. More frequent transfers enhance the virulence and longer transfers cause more attenuation.With suitable virulence the growth should completely cover the surface of medium in an Erlenmeyer flask in I2 to 14 days. At Gothenberg laboratory in Sweden the B.C.G. are grown successively on barren potato for 14 days; on glycerine potatoes for II days; II days in Sauton I and ii days in Sauton II and then they are prepared as vaccine
    10 : MANUFACTURING OF BCG VACCINE
    11 :
    12 : 3.6 (SUBPART-G) PACKAGING & LABELING Table-2: Types of packaging & labeling for BCG vaccine
    13 : 3.7 (SUBPART-H) HOLDING & DISTRIBUTION 3.8 (SUBPART-I) LABORATORY CONTROL SAMPLING OF BCG VACCINE INPROCESS QUALITY CONTROL OF BCG In-process controls play an important role in ensuring the consistency of the quality of biological medicinal products. Those controls which are crucial for quality (e.g. virus removal) but which cannot be carried out on the finished product should be performed at an appropriate stage of production. Sterility test Shake test
    14 : QUALITY CONTROL OF BCG VACCINE 3.9 (SUBPART-J) DOCUMENTATION The documentation must include the following:   Airway bill (AWB) Supplier’s invoice Packing list Lot release certificate (LRC) issued by the national regulatory authority (NRA) of the country of manufacture for each lot of vaccine supplied
    15 : 4. STANDARDIZATION OF B.C.G VACCINE There are two methods of standardization – Tuberculin test Skin reactivity 1. TUBERCULIN TEST Six guinea pig suffered with +ve tuberculin 50 human dose of B.C.G VACCINE is given If all guinea pig was treated Test pass If 2/3 guinea pig was treated but remaining 1/3 suffered from tuberculin Test will be repeated If further tuberculin will present Test fail
    16 : 2. SKIN REACTIVITY Four guinea pig Standard B.C.G vaccine Test B.C.G vaccine Intradermally with 20G needle Observe change in skin Observe change in skin If change in skin is similar TEST PASS
    17 : 5. CLINICAL TRIALS FOR A CANDIDATE VACCINE Table 3 : Phases of clinical trials
    18 : 6. MARKETED PRODUCTS BRAND NAME OTHER NAME OF BCG TheraCys® BCG BCG live TICE® BCG BCG vaccine
    19 : 7. CONCLUSION FDA provides some standard to maintain GMP of industry for manufacturing of BCG vaccine. The (clinical) efficacy of a vaccine is measured in terms of the percentage reduction in disease among vaccinated individuals that is attributable to vaccination. Though the WHO now emphasizes BCG’s utility in prevention of severe childhood disease (e.g. tuberculous meningitis), the main public health burden of tuberculosis is associated with adult pulmonary disease. BCG vaccine is used to prevent disseminated and other life threatening manifestations of Tuberculosis in infants and young children. However BCG vaccine does not prevent infection with Mycobacterium Tuberculosis. BCG vaccine efficacy against childhood tuberculosis, separately from that against adult tuberculosis, leprosy and other mycobacterial infections.
    20 : 8. REFERENCES Malik V., “Drugs & Cosmetic Act1940” Edition:6th,Page no 135-143. Martin A. Bustamante P. Chun A. H. C., “Physical Pharmacy, Lippincott Williams & Wilkins”,B. I. Publication Pvt. Ltd., Indian Edition: 4th ,2005, pp.500 -501. Nash R.A., Wachler A.H., “Pharmaceutical Process of Validation” Edition:3rd , Revised & Expanded Page no 640,641,642. Pharmaceutical Labeling A Review Pharmainfo_net.htm Remington, “The Science and Practice of Pharmacy”, Vol. 1,Mack publishing Company, Edition. 19th ,1995’pp. 304-310. Lachman L, Lieberman H. A, Kanig J. L., “Theory and Practice of Industrial Pharmacy”, Verghese Publishing House, Indian Edition: 4th ,1991,pp. 534-563.
    21 : Winfield A.J., Richards R.M.E, “Pharmaceutical practice”, Edition:3rd,Page no 117-122,227-229,231,234,271-272,286,575. www.fda.gov/ohrms/dockets/ac/03/transcripts/3926T1.htm www.pharmaceuticalonline.com/ www.ropack.com/cadre.html www.botlab.com/production.asp www.sanofipasteur.ca “WHO Global Tuberculosis Programme and Global Programme on Vaccines. Statement on BCG revaccination for the prevention of tuberculosis”, WHO Wkly Epidem Rec 1995; 70, pp. 229-231
    22 : THANK YOU

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