Our APIs: Thrombolytics, biological hormones, probiotics and postbiotics

BBT Biotech GmbH defines quality as the sum of reliability, quality of production, accuracy of analysis and documentation, and continuity of supply. The production of active ingredients is carried out under GMP conditions. We believe that this is a significant factor in meeting the expectations and requirements of our customers.

 

Furthermore, the basis for the continuous development of our high product quality are the GMP recommendations, the PIC guidelines, the Pharmacopoeias, and the specific requirements of our customers. These parameters are the main criteria for our product specifications.

Drug Master Files (DMFs) have already been issued for all our Active Pharmaceutical Ingredients (APIs) and are at the disposal of our customers for the registration of their finished products.

 

Our products are: proteins, probiotics as well as postbiotics as active substances.

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Thrombolytics

  • Streptokinase E.P.

    Streptokinase is a proteolytic enzyme which converts the zymogen plasminogen into the active enzyme plasmin. Plasmin attacks and dissolves fibrin in blood clots, thus allowing fibrinolysis to occur. The protein is obtained from the culture of hemolytic Streptococci and is highly purified.


    As a thrombolytic agent, streptokinase is used to dissolve blood clots in patients with thromboembolic diseases such as myocardial infarction, deep vein thrombosis, arterial thrombosis and embolism, coronary artery thrombosis, arteriovenous cannula occlusion and pulmonary embolism.


    The by BBT Biotech GmbH purified streptokinase  is manufactured under GMP conditions and meets the requirements of the monograph of the European Pharmacopoeia. It is available as an active pharmaceutical ingredient or as a finished drug.


    Streptokinase is available as:

    • Frozen solution
    • Powder
    • Finished drug 

  • Urokinase E.P. | J.P

    Urokinase is a serine protease which is isolated from human urine. Urokinase converts the zymogen plasminogen into the active enzyme plasmin. Plasmin targets the fibrin in blood clots and dissolves them, thus allowing fibrinolysis to occur. The protein is highly purified and features a high percentage of high molecular weight (HMW) urokinase. 


    As a thrombolytic agent, urokinase is used to dissolve blood clots in patients with thromboembolic diseases such as pulmonary embolism and myocardial infarction, and to dissolve blood clots that can form in intravenous catheters. In another application, urokinase can be used as a component of catheter lock solutions to prevent clotting in catheters filled with the catheter lock solution.


    The by BBT Biotech GmbH purified urokinase  is manufactured under GMP conditions and meets the requirements of the monograph of the European Pharmacopoeia and the monograph of the Japanese Pharmacopoeia. It is available as an EU registered active pharmaceutical ingredient or medical device component.


    Urokinase is available as:

    • Frozen solution

Biological hormones

Fertility hormones, also in highly purified grade

  • Human Chorionic Gonadotrophin (HCG | hpHCG) E.P.

    Gonadotropins are a family of glycoprotein fertility hormones with three members described: Follicle-stimulating hormone (FSH, Urofollitropin), Luteinising Hormone (LH) and Human Chorionic Gonadotrophin (HCG). All of these glycoproteins are composed of non-identical and non-covalently linked α and β subunits. The α subunit of FSH, LH and HCG is identical while the β subunit is specific to the respective polypeptide hormone. 


    Human chorionic gonadotropin (HCG) is derived from the urine of pregnant women and is highly purified. As a fertility hormone, it is used to treat infertility in women and to increase sperm count in men. It is also used to treat boys whose testicles have not descended into the scrotum normally.

    Human chorionic gonadotropin (HCG | hpHCG) purified by BBT Biotech GmbH is manufactured under GMP conditions and meets the requirements of the monograph of the European Pharmacopoeia. It is available in two grades of purity (purified | highly purified) as a frozen solution or lyophilized as an active pharmaceutical ingredient.


    Human Chorionic Gonadotropin (HCG | hpHCG) is available as:

    • Frozen solution
    • Powder

  • Human Menopausal Gonadotrophin (HMG | hp-HMG) B.P.

    Gonadotrophins are a family of glycoprotein fertility hormones with three members described: Follicle-stimulating hormone (FSH, Urofollitropin), Luteinising Hormone (LH) and Human Chorionic Gonadotrophin (hCG). All of these glycoproteins are composed of non-identical and non-covalently linked α and β subunits. The α subunit of FSH, LH and HCG is identical while the β subunit is specific to the respective polypeptide hormone. 


    Human menopausal gonadotropin (HMG) is a hormonally active substance that contains FSH and LH receptor-activating ingredients in an approximately 1:1 ratio. It is derived from the urine of postmenopausal women and is highly purified.

    As a fertility hormone, it is used to stimulate the growth and maturation of ovarian follicles in women. It is also used to induce an increase in estrogen levels and proliferation of the endometrium. In males, HMG is used to stimulate spermatogenesis by affecting the production of androgen-binding protein by Sertoli cells in the seminiferous tubules.


    The human menopausal gonadotropin (HMG | hpHMG) purified by BBT Biotech GmbH is manufactured under GMP conditions and meets the requirements of the British Pharmacopoeia monograph. It is available in two grades of purity (purified | highly purified) as a frozen solution or lyophilized as an active pharmaceutical ingredient.


    Human menopausal gonadotropin (HMG | hpHMG) is available as:

    • Frozen solution
    • Powder

  • Follicle-Stimulating Hormone (FSH | hp-FSH) E.P.

    Gonadotrophins are a family of glycoprotein fertility hormones with three members described: Follicle-stimulating hormone (FSH, Urofollitropin), Luteinising Hormone (LH) and Human Chorionic Gonadotrophin (HCG). All of these glycoproteins are composed of non-identical and non-covalently linked α and β subunits. The α subunit of FSH, LH and HCG is identical while the β subunit is specific to the respective polypeptide hormone. 

    Follikelstimulierendes Hormon (FSH; Follitropin) wird aus menschlichem Urin in den Wechseljahren gewonnen und ist hochrein.Follicle stimulating hormone (FSH; follitropin) is obtained from human urine during menopause and is highly pure.


    As a fertility hormone, it is used to stimulate the growth and maturation of ovarian follicles and therefore estrogen secretion in women. It is also used in the treatment of men to increase the function of spermatogenesis without affecting the Leydig apparatus or stimulating testosterone secretion.


    The follicle-stimulating hormone (FSH | hpFSH) purified by BBT Biotech GmbH is manufactured under GMP conditions and meets the requirements of the monograph of the European Pharmacopoeia. It is available in two grades of purity (purified | highly purified) as a frozen solution or lyophilized as an active pharmaceutical ingredient.


    Follicle Stimulating Hormone (FSH | hpFSH) is available as:

    • Frozen solution
    • Powder

Probiotics and postbiotics as API

Bacteria

  • Escherichia coli (E. coli Nissle 1917 and E. coli K12)

    Escherichia coli is a rod-shaped, Gram-negative facultative anaerobic bacterium found on plants, in the soil and especially in the intestines of humans and animals. BBT Biotech GmbH offers two non-pathogenic E. coli strains: E. coli Nissle 1917 and E. coli K12. Both strains are physiologically, genetically and biochemically well-known and their genome is fully sequenced. E. coli can be used as an probiotic drug. It can be further used as a production organism for various high quality and reliable microbial fermentation processes, such as the large-scale production of vitamins, biopolymers, amino acids, solvents/thickeners, chemical raw materials for the animal feed and food industry as well as additives for cosmetics or various pharmaceutical products including antibiotics, hormones or antibodies. 


    E. coli Nissle 1917 was isolated by Alfred Nissle in 1917 and has been used in probiotic medicines ever since. It has flagella for locomotion and attachment to the intestinal wall, can form biofilms via fimbriae, and secrete antagonistic microcins. It is particularly vital, which inhibits the growth of pathogenic germs in the intestine and stabilizes the natural function of the intestinal barrier. Furthermore, it is described that E. coli Nissle has an anti-inflammatory effect and is therefore also used to treat chronic inflammatory bowel diseases.


    E. coli K12 was isolated from a convalescent diphtheria patient in 1922 and added to the collection of the Stanford University Department of Bacteriology in 1925. It lacks most virulence factors such as toxins, O antigens, glycocalyx proteins or invasins.


    BBT Biotech GmbH offers highly viable concentrated E. coli or inactivated postbiotics manufactured under GMP conditions.

  • Staphylococcus aureus

     Staphylococcus aureus is a spherically shaped Gram-positive non-sporulating bacterium discovered in 1880. S. aureus is part of the common microbiota of the human body, such as the skin flora, the nostrils and as an inhabitant of the lower reproductive tract of females. This facultative anaerobe bacterium is often positive for catalase and nitrate reduction.


    BBT Biotech GmbH offers highly viable concentrated S. aureus or inactivated postbiotics manufactured under GMP conditions.

  • Pseudomonas aeruginosa

    Pseudomonas aeruginosa is a rod-shaped Gram-negative aerobic-facultative anaerobic bacterium discovered in 1900. P. aeruginosa is commonly found in all humid habitats such as soil, water or skin flora. It is also known as an important hospital germ that can be resistant to several antibiotics.


    BBT Biotech GmbH offers highly viable concentrated P. aeruginosa or inactivated postbiotics manufactured under GMP conditions.   

  • Enterococcus faecalis

    Enterococcus faecalis is a Gram-positive aerobic-facultative anaerobic growing coccus formerly classified as Streptococcus faecalis. It inhabits the gastrointestinal tract of humans and mammals and ferments glucose without gas production. E. faecalis can act both as a probiotic drug and as an opportunistic pathogen. 


    BBT Biotech GmbH offers highly viable concentrated E. faecalis or inactivated postbiotics manufactured under GMP conditions.

  • Lactobacillus acidophilus

    Lactobacillus acidophilus, also known as Bacillus acidophilus is a rod-shaped, Gram-positive bacterium which is commonly found in the human body (e.g. gastrointestinal tract, oral cavity, and vagina) and in various fermented foods such as fermented milk or yogurt. It is generally recognized as safe (GRAS). L. acidophilus grows at 37°C and ferments glucose to lactic acid without the formation of gases in the process. It can pass the gastrointestinal passage due to its high acid tolerance and the production of bacteriocin. 


    L. acidophilus is used as a probiotic drug. It attaches itself to the intestinal epithelium, acts as a barrier against pathogens and repairs the intestinal flora. In addition, it supports lactose digestion, strengthens the immune response and lowers cholesterol levels.


    BBT Biotech GmbH offers particularly vital, concentrated L. acidophilus produced under GMP conditions.

Yeast

  • Saccharomyces boulardii

     Saccharomyces boulardii, Hansen CBS 5926 is a variant of the yeast Saccharomyces cerevisiae, first isolated in the tropics. S. boulardii grows at 37°C and differs from S. cerevisiae in that it does not digest galactose or sporulate. 


    S. boulardii is used as a probiotic drug for the acute treatment of diarrhea and for preventive treatment during and after antibiotic administration. It is administered orally and colonizes the gastrointestinal tract within a few hours. This inhibits the growth of diarrhea pathogens and preserves or restores the natural intestinal flora.


    BBT Biotech GmbH offers highly vital concentrated S. boulardii that are manufactured under GMP conditions.

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Inhibitors and enzymes

  • Aprotinin

    Aprotinin is a broad-spectrum protease inhibitor, which modulates the systemic inflammatory response (SIR) associated with cardiopulmonary bypass (CPB) surgery.


    SIR leads to an interconnected activation of the hemostatic, fibrinolytic, cellular and humeral inflammatory systems. By inhibiting several mediators (e.g. kallikrein, plasmin), aprotinin leads to the attenuation of inflammatory reactions, fibrinolytics and the formation of thrombin. Aprotinin inhibits the release of pro-inflammatory cytokines and maintains glycoprotein homeostasis. In platelets, aprotinin reduces glycoprotein loss (e.g. GpIb, GpIIb/IIIa), while in granulocytes it prevents the expression of pro-inflammatory adhesive glycoproteins (e.g. CD11b).


    The use of aprotinin in CPB results in a reduction in the inflammatory response, which translates into a reduced need for allogeneic blood transfusions, less bleeding, and reduced mediastinal reexamination for bleeding.


    Aprotinin is available as:

    • Frozen solution
    • Powder

  • Hyaluronidase EP

    Hyaluronidase is an enzyme which catalyzes the degradation of hyaluronic acid (hyaluronan). Since hyaluronan is found in the extracellular matrix, hyaluronidase increases tissue permeability by lowering the viscosity of hyaluronan. It is used therapeutically to increase the absorption of drugs into tissue, such as for local anesthetics in ophthalmic surgery, and to reduce tissue damage in cases of extravasation of a drug. As hyaluronic acid is often used as a filler substance, subsequent hyaluronidase is essential to correct complications and unsatisfactory results.


    The hyaluronidase purified by BBT Biotech GmbH is of natural origin and is obtained from bovine testicular preparations. It is manufactured by BBT under GMP conditions and conforms to the requirements of the European Pharmacopoeia monograph.


    Hyaluronidase is available as:

    • Powder
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