Manufacturing Diagnostic Test Kits
Achieving ISO 13485, manufacturing under the license of international well-known companies and using the skills
and experiences of expert personnel, Bayerpaul provides the diagnostics kits listed below:
• Molecular (PCR & Real time PCR kits),
• Clinical Chemistry kits,
• Immunoassay (ELISA Kits)
• Rapid Diagnostic kits
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10 9واکسن و دارویی های فرآورده و اولیه مواد کیفی کنترل رفرانس آزمایشگاه
کیفــی کنتــرل آزمایشــکاه مجهزتریــن و بزرگتریــن عنــوان بــه ویرومــد تخصصــی آزمایشــگاههای مجموعــه
و ـکارـهم ـگاهـآزمایش ـوانـعن ـهـب ISO-17025 ـتانداردـاس ـتـدریاف ـاـب ـابقهـس ـالـس 12 از ـشـبی ـاـب ـورـکش در
ـازمانـس ،ـتـزیس ـطـمحی ـازمانـس ،ـتانداردـاس ـیـمل ـازمانـس ،ـاورزیـکش ـادـجه وزارت ،ـتـبهداش وزارت ـدـمعتم
ـهـزمین در )GC Reference Laboratory( ـیـجنوب ـرهـک ـسـرفران ـگاهـآزمایش ـکارـهم ـزـنی و ـورـکش ـکیـدامپزش
.ـدـنمای ـیـم ـتـفعالی ـهـفارماکوپ ـرـمعتب ـهایـروش ـاسـاس ـرـب ـرـزی ـایـه
کننده ضدعفونی مواد و دارو ،واکسن انواع کارآیی تعیین و کیفی کنترل آزمونهای *
دارویی اولیه مواد و دارو ،واکسن انواع استرلیتی و میکروبی آزمونهای *
دارویی اولیه مواد و دارو ،واکسن انواع تخصصی شیمیایی آزمونهای *
GC , GC/MS , HPLCکروماتوگرافی روش با دارویی های فراورده و اولیه مواد شیمیایی آنالیز *
با دارویی های فراورده و اولیه مواد ،مکملها در معدنی امالح و ویتامینها گیری اندازه *
HPLC کروماتوگرافی روش
با دارویی های فراورده و اولیه مواد در سنگین فلزات و کمیاب عناصر گیری اندازه *
Atomic Absorption اتمی جذب روش
کروماتوگرافی روش ـاـب دارویی ـایـه ـراوردهـف و ـهـاولی ـوادـم در ـرهـکل و ـفرهـارگانوفس ـمومـس ـدهـباقیمان ـنـتعیی *
GC GC/MS,,HPLC
بیوتیکها آنتی انواع اثر تعیین و خلوص گیری اندازه *
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Mycotoxin Rapid test Kits:
Mycotoxins Rapid test kits can qualitatively with high sensitivity (ppb) determine aflatoxins in milk or cereals less
than 20 minutes: Total Aflatoxin, Aflatoxin B1/B2, Aflatoxin G, Aflatoxin M1. (Page 7 Table 6)
Quick Extraction Kits
Quick extraction kits for Toxins, Drugs and Pesticides are manufactured in Bayerpaul Group using the most
advanced technologies of the world. These kits separate toxins, drugs and pesticides from human/animal organs,
plants, food, feed sources and drinks with high accuracy, minimized time and lower cost.
Extracting the high percentage of toxins, drugs, medicines with high recovery range.
• Increasing work proficiency by decreasing test time, sample and chemical material.
• Protecting personnel health and dramatic decreasing of extraction expenses.
• Omitting chlorinated and non polar organic solvents
• Decreasing interfering matrixes in analysis including fatty acids, proteins, strolls , pigments
Quick Extraction kits which are included in Bayerpaul products are as follow: (Page 8 Table 7)
o Human Organs (Blood, Urine, Hair and Skin)
o Food and Drinks (Powder milk, Tuna, Supplements, Drink water and fruits juice)
o Plant (Grin, Tea, Rise, Olive kern and Fruit)
Reference QC Laboratory of Raw Material, Vaccine and Pharmaceutical Products:
• Physicochemical and microbiological test for vaccines, raw materials and pharmaceutical
products on the basis of BP, EU and US pharmacopeia.
• QC and efficiency tests of vaccines, pharmaceutical products, raw material and disinfectants.
• Sterility tests of vaccines and sterile pharmaceutical products.
• Chemical analysis of raw material, pharmaceutical products by HPLC, GC/MS, GC methods.
• Measuring heavy metals, vitamins, rare elements and minerals in supplements, raw material and
pharmaceutical products by Atomic Absorption, Graphite furnace and Amalgam methods.
• Determination of organophosphorate and chlorate residual in water, raw material and
pharmaceutical products by GC and GC/MS methods.
Quick Extraction Kit for Drug, Toxin & Pesticide
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Immunoassay (ELISA) Diagnostics Test Kits
Immunoassay (ELISA) is conducted as the most routine method with high sensitivity and specificity for primary
diagnosis and also wide range of screening survey all around the world.
Bayerpaul Group manufactures Immunoassay (ELISA) kits under the license of Green Cross Corp., South Korea,
which has international approvals and CE. Bayerpaul presents the kits to the market after conducting QC tests in
national reference laboratories. Quantitative measurement of Antibody and Antigen of Hepatitis B virus (HBsAg,
Anti-HBs), Hepatitis C virus (HCVAg, HCVAb), Human immunodeficiency virus (HIV 1/2Ag, HIV 1/2Ab),
Influenza A virus Ab and Helicobacter pylori (H.Pylori Ab) are conducted according to Page 4 Table 2.
Biochemical Diagnostics Test Kits
Biochemical kits have the most usage in medical diagnostics labs. General and specialty specifications of these kits
are according to international standards. Bayerpaul manufactures under the license of international well-known
companies and presents the products after conducting QC tests in national reference laboratories.
• Comparing to available products Bayerpaul Biochemical Kits have more accuracy, precision,
homogeneity and are more linear
• BP products handling and storage conditions and also its usage is easier and more economical.
• The kits have international standard, high quality and longer storage time.
• Using these kits is possible through automatic and manual methods
• Operating of the kits is possible through the whole auto analyzers ( American, European & Asian)
Biochemical kits which has been presented to market are listed according to Page 5 Table 3.
• Glucose, ACE, Albumin, AST (SGOT), ALT (SGPT), Calcium, Cholesterol, CPK, Creatinine,
G6PD (qualitative & quantitative), Iron, LDH, Phosphorus, Pyrogallol red, (protein), Total
Bilirubine, Direct Bilirubine, TIBC (Full Automated), Total protein, Triglycerides, Urea, Uric acid
Rapid Diagnostics test Kits
Reading the test results is possible through 15 minutes. Conducting test does not need any in-vitro space or
equipment.
Producing rapid clinical diagnostics kits of Bayerpaul for diagnosis of infectious disease and drug of abuse are done
under the license of Green Cross Corp. of South Korean refer to Page 6 Table 4 & Page 7 Table 5).
• HBs Ag, Anti-HBs, HCV, HAV IgG, HIV1/2, Influenza A&B, Vibrio cholera, H. pylori, PSA
• Drug of Abuse Diagnosis in urine and saliva
Real time PCR, ELISA, Biochemical & Rapid test Kits 1112
Manufacturing Human Viral Vaccines
Viral vaccines production line with more than 3500 square meters of clean rooms and advanced equipments
has the annual capacity of producing more than 20 million doses of human viral vaccines on the basis of GMP
requirements and also WHO standards.Currently human influenza vaccine is considered as the main product in
vaccine production line.
Vaccines developing in R&D Department:
• Epidemic influenza vaccine
• Human rabies vaccine
• Human Papiloma vaccine
• Rotavirus vaccine
• Inactivated Polio vaccine
• Chicken pox vaccine
Manufacturing Diagnostic Test Kits
Achieving ISO 13485, manufacturing under the license of international well-known companies and using the skills
and experiences of expert personnel, Bayerpaul provides the diagnostics kits listed below:
• Molecular (PCR & Real time PCR kits),
• Clinical Chemistry kits,
• Immunoassay (ELISA Kits)
• Rapid Diagnostic kits
Molecular Diagnostics Kits (PCR and Real Time PCR)
Molecular diagnostic kits have been produced by utilizing the most advanced technology.
Bayerpaul Group manufactures Molecular Diagnostics Kits under the license of Green Cross Corp., South Korea,
which has international approvals and CE. Bayerpaul presents the kits to the market after conducting QC tests in
national reference laboratories which are complied with the European standards.
Qualitative and quantitative determination of disease factors such as Hepatitis B virus (HBV), Cytomegalovirus
(CMV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), Human Papiloma virus (HPV), Influenza
virus (A &B), BK virus, JC virus and Helicobacter pylori (H.P.) are conducted according to Page 3 Table 1.
Manufacturing Human Viral Vaccines
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Bayerpaul Group a knowledge based Company was found in the 2011 by Dr Esmaeil Saberfar
virologist in Tehran Pardis Technology Park. Bayerpaul began its activities in the year 2014
with producing human influenza vaccine and wide range of diagnostic test kits. Bayerpaul
facility divides into four production lines, QC laboratory and R&D department which deal
with the main following sections:
• Manufacturing Human viral vaccines
• Manufacturing diagnostics test kits
• Manufacturing antiviral and anticancer drugs
• Reference Quality Control laboratory for pharmaceutical products, diagnostic kits
and vaccines.
Bayerpaul Group by obtaining national approvals, international certificates of ISO 13485, ISO
17025, ISO 9001, ISO 10004 and also by attracting highly qualified and expert personnel seeks to
enhance the quality of health care by developing novel vaccines and diagnostic test kits.
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