A5033391594- Pneumonia and Respiratory Infections
- Bacterial Infections and Vaccines
- Glycosylation and Glycoproteins Research
- Pneumocystis jirovecii pneumonia detection and treatment
- Respiratory viral infections research
- Animal Disease Management and Epidemiology
- Viral gastroenteritis research and epidemiology
- Salmonella and Campylobacter epidemiology
- Streptococcal Infections and Treatments
- Immune Response and Inflammation
- Virus-based gene therapy research
- Hepatitis B Virus Studies
- Viral Infectious Diseases and Gene Expression in Insects
- Protein purification and stability
- Viral Infections and Vectors
- Biochemical Analysis and Sensing Techniques
- Hepatitis C virus research
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Viral Infections and Immunology Research
- Cervical Cancer and HPV Research
- Acoustic Wave Resonator Technologies
- Virology and Viral Diseases
- Probiotics and Fermented Foods
- Carbohydrate Chemistry and Synthesis
- Veterinary medicine and infectious diseases
Biological E (India)
2017-2024
Biotech Park
2024
Indian Immunologicals (India)
2013
Background Pneumococcal conjugate vaccines (PCVs) have considerably reduced the burden of invasive pneumococcal disease (PD) worldwide. Consequently, though, there has been an increase in non-vaccine serotype-induced PD particularly at both extremes age. Biological E developed a 14-valent PCV (PNEUBEVAX 14®) that includes additional serotypes 22F and 33F. PNEUBEVAX 14® was shown to be safe, immunogenic, non-inferior Prevenar-13® (PCV-13) when administered infants pivotal phase 3 trial. In...
The current scenario of typhoid fever warrants early prevention with conjugate vaccines in susceptible populations to provide lifelong protection. We conducted a multicenter, single-blind, randomized, Phase 2/3 study assess the immunogenicity and safety Biological E's Typhoid Vi-CRM197 vaccine (TyphiBEVTM) compared Vi-TT manufactured by Bharat Biotech International Limited (Typbar-TCV; licensed comparator) healthy infants, children, adults from India. study's primary objective was...
Abstract Maintaining the molecular size (MS) of Streptococcus pneumoniae capsular polysaccharide within specified range is essential for manufacture conjugate vaccines, either through physical or acid hydrolysis before use in conjugation process. Polysaccharide MS typically reduced, with high-pressure homogenization as an approach, preserving their chemical structure. When average Pneumococcal serotype-1(CPS1) exceeds 1200 kDa during fermentation, using a homogenizer to reduce its 150–250...
Measles is a major cause of childhood mortality and one-third the world's deaths occur in India. Rubella causes lifelong birth defects (Congenital Syndrome). Although neither condition has cure, MR vaccination can successfully prevent both diseases. The safety Biological E's live attenuated vaccine (BE-MR) was established 4-5-year-old healthy children. This phase-2/3 study conducted to assess immunogenicity BE-MR 9-12 month old infants. Overall, 600 subjects were enrolled equally randomized...
Current polysaccharide conjugate vaccine manufacturing process involves conjugation of with protein followed by separation/purification the from reaction components and free polysaccharide/protein, preparative Size-Exclusion Chromatography (SEC). Each SEC fraction is analyzed pooled based on its molar mass absence polysaccharide. In present work, we have evaluated in-line Multi Angle Light Scattering (MALS) as a Process Analytical Technology (PAT) tool to eliminate need for offline analysis...
Background: Japanese encephalitis (JE) is endemic in various parts of India. Due to the limited treatment options available, a new option that safe and effective highly expected for existing medical needs. Methods: In present randomized Phase-2/3 study, safety, immunogenicity, reactogenicity JE-vaccine manufactured by Biological E (BE-JE), given 2-dose schedule, 28-days apart was assessed 456 healthy ≥1 <3-year-old children compared licensed with 3-dose schedule Green-cross-corporation...
ABSTRACT Background Introduction of pneumococcal conjugate vaccines (PCV) reduced the cases disease at global level. However, there is an increase in clinical and economic burden PD from non-PCV serotypes, particularly pediatric elder population. In this study, immunogenicity safety BE’s 14-valent PCV (PNEUBEVAX 14 TM ; BE-PCV-14) containing two additional epidemiologically important serotypes (22F 33F) comparison to PCV-13 was evaluated infants. Methods This a pivotal phase-3 single blind...
Abstract Polysaccharide‐protein conjugates elicit a protective immune response in children below 2 years. The conjugated antigens using different carrier proteins generate T‐cell dependent antibody and increased titers adults than unconjugated polysaccharide vaccines. Different marketed conjugate vaccines, contain such as cross‐reactive material, Tetanus Toxoid, Diphtheria toxoid Protein D (derived from non‐typeable Haemophilus influenzae ). Quantification of (free poly) protein protein) the...