BBio is a Netherlands-based end-to-end vaccine manufacturer of viral and bacterial vaccines, with its facilities in Bilthoven - Utrecht Science Park Bilthoven. A carve-out of the former Netherlands Vaccine Institute, it was acquired by Serum Institute of India in 2012 and today employs a little under 500 people.
The company has a long-standing track record in supplying vaccines to European markets and works with global health partners such as UNICEF, PAHO, and WHO & /GAVI. With the manufacturing of polio vaccines, BBio is key contributor to the worldwide program for polio eradication. BBio is part of the EU funded pandemic preparedness program, having ever warm vaccine manufacturing facilities. Together with SII, BBio offers its unmatched end-to-end vaccine capabilities to vaccine developers and innovators, making affordable vaccines and therapies available worldwide
Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SII's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SII's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second malaria vaccine to be authorized for use in children in malaria-endemic regions. Moreover, SII has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide.
SLS Europe is a pharmaceutical consulting and development company based in Hannover, Germany. Established in 2002, SLS Europe provides strategic expertise in pharmaceutical development, clinical trial management, and regulatory affairs, specializing in guiding biotechnology and pharmaceutical companies through the European and global regulatory landscape. The company supports product development from R&D to commercialization, collaborating with partners to bring innovative products to both European and global markets.
As the Marketing Authorization Holder, SLS Europe ensures regulatory compliance and oversees the safety and efficacy of its products throughout their lifecycle. SLS Europe is part of the Cyrus Poonawalla Group, enhancing its capacity in the pharmaceutical sector.
This medicinal product is subject to additional monitoring. Name: SIILTIBCY (0.5 microgram + 0.5 microgram)/mL solution for injection Mycobacterium tuberculosis derived antigens (rdESAT 6 and rCFP 10). Pharmaceutical form and composition: One dose (0.1 mL) contains 0.05 microgram of rdESAT 6* and 0.05 microgram of rCFP 10**. *Recombinant dimer of Mycobacterium tuberculosis early secretory antigenic target1; **Recombinant culture filtrate protein of Mycobacterium tuberculosis1; 1Produced in Lactococcus lactis cells. Multidose vial. One vial (1 mL) contains 10 doses of 0.1 mL. Therapeutic indication: SIILTIBCY is indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. This medicinal product is for diagnostic use only. Posology and method of administration: Posology The dose is 0.1 mL of SIILTIBCY. Method of administration SIILTIBCY should be prepared and administered via intradermal injection by healthcare professionals trained for the Mantoux technique. The medicinal product should be administered with adequate hygiene of the hands and using aseptic technique, as follows: Withdraw 0.1 mL of SIILTIBCY using a 1 mL syringe with a short bevel needle. Before drawing SIILTIBCY from the multidose vial, expel any air from the syringe. If the vial was already opened, swab it with an alcohol swab and let it dry before use; Administer the 0.1 mL of SIILTIBCY intradermally in the middle-third of the forearm using the Mantoux technique. Therefore, stretch the skin slightly and hold the needle almost parallel to the skin surface with the bevel upwards. Insert the tip of the needle into the superficial layer of the dermis. Make sure the needle is visible through the epidermis during the injection. Do not apply the test in areas of scars, rashes, burn or tattoos; Inject the drawn 0.1 mL solution slowly. A small-blanched papule of 8-10 millimetres (mm) in diameter will appear, which should disappear after about 10 minutes. If the papule does not appear, repeat a new injection of 0.1 mL of SIILTIBCY on the other arm or on the same arm at least 4 cm away from the first injection site. The induration is measured 48 to 72 hours after the injection by a trained healthcare professional. Measure the diameter of the induration transversely to the long axis of the forearm with a ruler. To allow ease with measurement, a flexible (or easily bendable) ruler is suggested. An induration of ≥ 5 mm is considered as a positive test result, which indicates infection with Mycobacterium tuberculosis. Contra-indications: Hypersensitivity to the active substances or to any of the excipients disodium hydrogen phosphate dihydrate (E339), potassium dihydrogen orthophosphate (E340), potassium chloride (E508), sodium chloride, polysorbate 20 (E432) and phenol. Hypersensitivity to Lactococcus lactis. Severe local or systemic reaction to other Mycobacterium tuberculosis derived products. Special warnings and precautions for use: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations: Anaphylaxis Anaphylactic or other allergic type reactions are possible following administration of SIILTIBCY. Appropriate equipment for management of such reactions should always be available during the conduct of the test. Close observation for at least 15 minutes is recommended following the test. Route of administration Adherence to the Mantoux technique when administering SIILTIBCY is essential for obtaining reliable results, therefore avoid subcutaneous or intramuscular injection. Special populations The reactivity to SIILTIBCY can be lower or give false negative results in immunocompromised individuals, including those receiving immunosuppressant therapy and human immunodeficiency virus (HIV) positive individuals if cluster of differentiation 4 positive (CD4+) thymus cell (T cell) count is < 100 T cells/mm3. A positive test result indicates infection with Mycobacterium tuberculosis regardless of the CD4+ T cell count. There may be an increased risk of false-negative results in the elderly population due to immunosenescence with age. Previous exposure to non-tuberculous mycobacteria SIILTIBCY does not identify subjects with previous exposure to non-tuberculous mycobacteria as well as those who received Bacillus Calmette-Guérin vaccine or therapy, and thus use for this purpose is not appropriate. Diagnosis of active tuberculosis SIILTIBCY cannot be used as stand-alone tool for diagnosis of active tuberculosis disease. In addition, risk assessment, radiography, and other diagnostic evaluations should be considered for subjects suspected to have active tuberculosis. Excipients This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. This medicinal product contains 0.011 mg of polysorbate 20 in each dose, which is equivalent to 0.11 mg/mL. Polysorbates may cause allergic reactions. Undesirable effects: Very common (≥ 1/10): Injection site pruritus. Common (≥ 1/100 to < 1/10): Headache, Injection site haematoma, Injection site vesicles, Injection site induration, Injection site swelling, Injection site pain, Injection site rash, Injection site erythema. Uncommon (≥ 1/1 000 to < 1/100): Gastroenteritis, Lymphadenopathy, Dizziness, Diarrhoea, Nausea, Rash, Pruritus, Pain in extremity, Injection site ulcer, Injection site haemorrhage, Pyrexia, Malaise, Fatigue, Injection site discolouration, Pain, Influenza-like illness. Rare (≥ 1/10 000 to < 1/1 000): Lymphadenitis, Eosinophilia, Head discomfort, Paraesthesia, Vomiting, Hepatitis, Jaundice, Transaminases increased, Night sweats, Urticaria, Myalgia, Arthritis, Axillary pain, Injection site inflammation, Injection site urticaria, Injection site nodule, Injection site papule, Chills, Injection site hypoaesthesia. Pharmacotherapeutic group: Tuberculosis diagnostics ATC code: V04CF Full product information: for the full product information, please consult the SmPC on www.ema.europa.eu. Date: March 2025. Marketing Authorisation Holder: Serum Life Science Europe GmbH, Ahrensburger Str. 1, 30659 Hannover, Germany, +49 511 169 90 80. For other information, Bilthoven Biologicals BV, PO Box 457, 3720 AL Bilthoven, The Netherlands, +31 (0)30 – 800 4800, info@bbio.nl. STBCY/EU/004-3/2025