The present invention provides improved methods of production of rabies viral antigen. According to the instant method if microcarriers along with virus infected cells are transferred to a flat surface , instead of continuing the harvesting in a bioreactor, then the infected cells are found to live longer resulting ...

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A method for reduction or removal of protein impurities from a complex cellular bacterial lysate and purification of capsular polysaccharide thereof.

A kit for eliciting an efficient immunological response in a host consisting of a vaccine; an immunological adjuvant comprising therapeutic quantities of an aqueous extract of at least one medicinal plant selected from a group of medicinal plants comprising ashwagandha [withania somnifera], shatavari [asparagus race...

A process for preparing HIB conjugate with tetanus toxoid comprising the steps of: a. Activating HiB polysaccharide; b. Modifying carboxylic acids of tetanus toxoid to amines to create sufficient surface amino groups; c. Conjugating activated HiB Polysaccharide (PRP) and modified Tetanus Toxoid; d. Precipitating...

A process for lyophilization of Formulation Containing Mannitol is claimed.

Abstract Lyophilized preparation of a benzimidazole compound by an improved lyophilization cycle Lyophilized pantoprazole preparations having low residual moisture content obtained by an improved and cost-effective lyophilization process.Said short duration lyophilization process comprises of a sublimation step ...

The present disclosure provides polyvalent polysaccharide-protein conjugates compositions comprising a plurality of capsular polysaccharides of Streptococcus pneumoniae serotypes conjugated to a carrier protein. The Streptococcus pneumoniae serotypes include Streptococcus pneumoniae serotypes 3, 15B and 18C. ...

The present invention relates to a rapid and reproducible Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) based method for quantifying residual 4-pyrrolidinopyridine(4-PPY) in polysaccharide-protein conjugate vaccines prepared by cyanylation conjugation chemistry using l-Cyano-4- pyrrolidinopyridini...

A method for preparing polysaccharide-protein conjugates with improved immuriogenicity and less free polysaccharide content for Streptococcus pneumoniae polysaccharides containing phosphodiester linkage, particularly 19A , 19F , 6A and 6B . The conjugation process minimizes cyanylation agent by-product mediated degr...

The invention provides thermostable polysaccharide based lyophilized vaccines,particularly polysaccharide-protein conjugate vaccines and methods for preparation thereof.

The invention provides immunogenic polysaccharide protein conjugates comprising capsular polysaccharides from N.Meningitidis serogroup X and methods for preparation thereof.

The invention provides methods for s tabi1izing polysaccharide protein conjugates,particularly pneumococcal polysaccharide-protein bulk conjugates.

The present invention relates to a rapid and reproducible micellar electrokinetic capillary chromatography based method for quantifying residual 4-pyrrolidinopyridine(4- PPY)and4-dimethylaminopyridine(DMAP) in polysaccharide- protein conjugate vaccines prepared by cyanylation conjugation chemistry using 1-Cyano...

Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof The present invention provides methods for preparation of stable multivalent pneumococcal polysaccharide-protein conjugate vaccine formulations. Instant stable formulations show optimal pe...

To provide a method for simultaneous evaluation of multiple antibodies or multiple antigens in single samples, wherein carboxylated polystyrene microsphere sets are conjugated with a defined 23 candidate polysaccharide antigens by an individually optimized conjugation method and are mixed to enable the detection of ...

The present invention relates to a process for preparing an enriched plant fraction containing a mixture of Withaferin A and Withanolide A, obtained from the roots of plant Withania Somnifera.

A method for reduction or removal of “polyose type”teichoic acid impurity from a complex cellular bacterial lysate and purification of capsular polyoses thereof.

The present invention is directed to improved methods of Enterovirus inactivation by formaldehyde in presence of tromethamine buffer resulting in maximum recovery of D-antigen. Subsequent adsorption of said sIPV on aluminium hydroxide provides significantly dose reduced sIPV compositions.

This invention provides an improved process for manufacturing a Rabies monoclonal antibody (HuMab 17C7) that results in low osmolality, minimum secondary metabolites like ammonia and lactate, enhanced cell growth and productivity, minimum aggregation or degradation of monoclonal antibody during purification, thereby...

To provide a novel and efficient method for estimation of free polysaccharides in multivalent polysaccharide protein conjugate vaccines,wherein anti-carrier protein antibody coupled beads are mixed with sample containing multivalent protein polysaccharide conjugates to enable the separation of conjugated and unconju...

The invention relates to optimization of culture conditions that utilizes different feed solutions and feeding strategies for improving capsular polyoses (CP) production.

This invention is directed to methods for removing, preferably simultaneously and in one step, multiple impurities form crude culture samples, and, in particular, the removal of media components, protein, nucleic acids lipids, and lipopolysaccharides to ultralow levels. Preferably the purification process comprises:...

LYOPHILIZED VACCINE The instant invention provides a lyophilized virus formulation obtained by a short lyophilization cycle,wherein post-lyophilization virus titer loss is minimum.The said virus formulation is of rabies virus comprising an advantageous and novel stabilizer composition.

The present invention claims a method of enhancing immune response to an antigen in a composition comprising two or more antigens by manipulating the type or amount of adjuvant co-delivered with the antigen.

Process for immobilization of an enzyme, characterized by the steps comprising (a) activating said support with 1-ethyl-3 (3-dimethylaminopropyl) carbodiimide hydrochloride and N-hydroxysulfosuccinimide, (b) covalent coupling of activated support with said enzyme at a pH ranging from about 4.5 to 6.5 and tempera...

A method of isolating and purifying protein polysaccharide conjugates using hydrophobic interaction chromatography. Crude protein polysaccharide conjugate mixtures are subjected to ultrafiltration to remove unreacted protein, and loaded onto a column filled with a suitable hydrophobic resin. Elution is effected wi...

The present invention provides a simple,reproducible, inexpensive and convenient method for facile cleavage of high molecular weight bacterial cell surface native Polysaccharides by invacuo heating thus obtaining antigenic Polysaccharide fragments with size reduced by a factor not more than 10 times. The said depo...

The present invention provides a method of purifying diphtheria toxin comprising (1) fermenting a microorganism strain capable of producing diphtheria toxin using media supplemented with a mixture of glycerol, nitrogen salts & trace elements whereby the addition of glucose maintains microorganism growth effective ...

The present invention is related to non-glycosylated EPO with improved stability and half lives. The present invention also provides a process for the preparation of a non-glycosylated EPO with improved stability and half life. The invention provides an erythropoietin compound comprising a non-glycosylated human ery...

The present invention relates to a vaccine comprising polysaccharide vaccine antigen and a novel adjuvant which provides enhanced immmunological response in the host compared to known adjuvant compositions. Said novel adjuvant is capable of invoking T cell dependent immune responses to T cell independent antigens su...

The instant invention claims stable aluminium phosphate nanoparticles and a process for preparation thereof.

The present invention provides a method for the production and purification of PSA with high molecular weight from 70 KD to 100 KD comprising (1) fermenting an Escherichia coli K1 LP 1674 strain capable of produsing Polysialic acid using an appropriate carbon source, in order to maintains microorganism growth effect...

The present invention relates to a method of preparation of an immonogenic polysaccharide protein conjugate-by dry heating. A further aspect of the invention relates to a method of preparation of a polysaccharide protein conjugate comprising the steps of:a)reacting polysaccharide with protein; b)subjecting the react...

The present invention describes multi-dose lyophilized formulations of multivalent meningococcal capsular polysaccharides by utilizing a novel stabilizer composition.The said stabilizer is a mixture of saccharides,sugar alcohol and amino acids.

The instant invention provides cost effective and immunogenic IPV formulations.The said formulations contain an adjuvant that ca.n enable 5 to 10 fold dose reduction for inactivated polio virus vaccines.

The present invention refers to conjugate of erythropoietin having higher bioactivity comprises an Erythropoietin glycoprotein having N-terminal α - amino group and aldehyde derivatives of polyethylene glycol, said erythropoietin glycoprotein being selected from the group consisting of human erythropoietin and analo...

A stable & immunogenic lyophilized formulation of polysaccharide carrier protein conjugate using two or more carbohydrate excipients is claimed.

A monoclonal antibody based immunocapture ELISA was developed for the quantitation. The assay includes immobilization of the monoclonal antibody to rabies glycoprotein on the microtiter wells and blocking the free polystyrene surface with suitable blocking reagent. The monoclonal antibody is developed indigenously t...

The instant invention provides highly pure Polysialic acid and process for preparation thereof.

The present invention relates to the field of polysaccharide and polysaccharide protein conjugate vaccines, in particular to a novel, Reproducible and cost-effective size reduction method of polysaccharides by using a non-chemical method to yield fragments of desired size wherein desired structural features of the p...

This invention provides a sandwich microsphere immunoassay with a bead-based suspension array system for specific estimation/ Quantification of rabies glycoprotein antigen from a)in-process and b) final rabies vaccine bulk samples. The instant method can be used for in-process control in the production of ra...

The present invention provides novel lyophilized rotavirus vaccine formulations and methods of their preparation.The formulations include vaccine stabilizers, resulting in a vaccine formulation with enhanced stability and minimal loss of potency. The rotavirus vaccine formulations comprise an advantageous ratio of a...

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The instant invention relates to a process for preparation of a stable polysacharide-carrier protein conjugate vaccine substantially free of un-conjugated polysaccharide and also discloses lyophilization of the conjugate in the presence of one or more carbohydrates, preferably selected from group of sucrose, mannito...

A novel alcohol and CTAB free process for purification of capsular polysaccharides ,wherein the C-polysaccharide, protein,nucleic acid content of the purified polysaccharide is substantially reduced The said process is cost efficient and less laborious.

The current invention provides improved methods for preparing immunogenic conjugates wherein multiple bacterial capsular polysaccharides are linked to a single type of carrier protein,particularly polysaccharide-protein bivalent conjugates by utilizing cyanylating agent other than CDAP,resulting in optimal conjugati...

The invention provides a novel & cost-efficient process of concentrating rotavirus to obtain gel-adsorbed rotaviral liquid compositions,wherein the viral titer post-adsorption is atleast 10 fold greater than the pre-adsorption viral titer with partial removal of nucleic acid contaminants.Also present invention provi...

The present invention provides novel methods for preparing antigen adsorbed chitosan nanoparticle compositions, such that nasal delivery of said vaccine composition results in improved immunogenicity profile as compared to preexisting parenteral compositions.

Abstract Production of high yields of bacterial polysaccharides The instant invention provides improved culture ,fermentation and purification conditions for preparing Neisseria meningitidis polysaccharides.The invention in particular relates to a novel fermentation medium ,optimal feed solution addition strateg...

The present invention discloses a novel process of preparation of rabies vaccine. The process includes multiplying Rabies virus on Human diploid cells such as MRC-5. The Human diploid cells were grown on microcarriers and grown cells infected on with rabies virus seed. The multiplication of rabies virus is effected ...

The present invention relates to method of purifying tetanus toxoid using gel- filtration chromatography to achieve highly monomeric form and its use has been suggested mainly in conjugation vaccines to improve quality and consistency. In the present invention a unique dual column large scale gel-filtration chromato...

The instant invention provides significant improvement in bacterial capsular polysaccharide yield at fermentation harvest stage, particularly Neisseria meningitidis capsular polysaccharides by gradual addition of an antifoam agent alongwith an optimal feed solution from log phase onwards. Specifically, antifoam incr...

The present invention relates to the field of immunoassays for Gram negative bacteria, in particular N. meningitidis. The invention provides a simple and affordable immunoassay to quantitate polysaccharides in meningococcal vaccines for the evaluation of antigen content and lot-to-lot manufacturing consistency. The...

The present disclosure provides polyvalent polysaccharide-protein conjugates compositions comprising a plurality of capsular polysaccharides of Streptococcus pneumoniae serotypes conjugated to a carrier protein. The Streptococcus pneumoniae serotypes include Streptococcus pneumoniae serotype 12F and Streptococcus pn...

Abstract Process for stabilization of bacterial protein and its use in vaccine manufacturing thereof The present invention relates to preparation and stabilization of proteins during storage. The present invention addresses the issue of short shelf life of monomeric toxoids to be utilized as either as an antigen...

ABSTRACT LIVE ATTENUATED INFLUENZA VACCINE COMPOSITION AND PROCESS FOR PREPARATION THEREOF The present disclosure provides compositions and methods for manufacturing and obtaining a live attenuated Influenza vaccine (LAIV) composition that can be delivered intranasally to provide protection against influenza virus...

The present invention is directed to improved methods of Enterovirus inactivation by formaldehyde in presence of tromethamine buffer resulting in maximum recovery of D-antigen. Subsequent adsorption of said sIPV on aluminium hydroxide provides significantly dose reduced sIPV compositions.

Novel multivalent vaccine composition The present invention relates to stable, immunogenic combination vaccine(s) comprising a mixture of antigens for prevention and prophylaxis of infections caused by Rotavirus, Poliomyelitis virus, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium tetani, Bor...

ABSTRACT Multiplex bead based assay for quantification of multiple types of carrier protein in a multivalent conjugate vaccine composition The present disclosure relates to a bead based competitive inhibition assay for estimation of individual concentration of carrier proteins in a multivalent polysaccharide prote...

The present disclosure relates to a robust method for assaying unconjugated polysaccharide (Ps) in a polysaccharide-protein conjugate vaccine compositions, preferably meningococcal pentavalent(ACWYX)conjugate comprising of a Neisseria meningitidis serogroup X polysaccharide conjugate, atleast two different types of ...

A method for assaying unconjugated or free protein in a monovalent or multivalent polysaccharide-protein conjugate preparation wherein said method comprises steps of i) estimating total protein concentration by micro - bicinchoninic acid protein assay (Micro-BCA); ii) estimating unconjugated or free protein concentr...

ABSTRACT An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof An immunogenic composition comprising of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen, Hepatitis B surface antigen (HBsAg), inactivated whole-cell B. ...

The present disclosure relates to use of affinity chromatography for separation of free or unconjugated carrier protein from a carbohydrate protein conjugate vaccine, followed by a bead based competitive inhibition assay for estimation of individual concentration of free or unconjugated carrier protein(s) in a monov...

ABSTRACT STABLE VACCINE COMPOSITIONS COMPRISING INTER ALIA LIVE ATTENUATED RECOMBINANT FLAVIVIRUS AND PROCESS FOR PREPARATION THEREOF Stable lyophilized immunogenic compositions comprising inter alia live attenuated recombinant flaviviruses, more preferably live attenuated recombinant dengue viruses, atleast one c...

ABSTRACT COMBINATION VACCINE COMPOSITION COMPRISING REDUCED DOSEINACTIVATED POLIOVIRUS AND METHOD FOR PREPARING THE SAME The present disclosure relates to a fully liquid immunogenic composition comprising a combination of antigens/immunogens. The immunogenic composition comprises optimum amount of antigens/immunog...

The present disclosure relates to a vaccine composition comprising Neisseria meningitidis polysaccharide-proteinconjugates. The composition typically comprises Neisseria meningitidis serogroup A conjugated to tetanus toxoid, Neisseria meningitidis serogroup C conjugated to CRM197, Neisseria meningitidis serogroup Y ...

The invention, describes an efficient platform for antibody manufacturing and formulation, that provides i) cell culture process with improved feeding strategy resulting in high antibody titer between 2 gm/L to 5 gm/L; ii) improved purification process showing optimal percentage recovery, high purity monomer content...

ABSTRACT METHOD FOR OBTAINING PURIFIED BACTERIAL POLYSACCHARIDES The present disclosure relates to a method for obtaining purified bacterial polysaccharides. The method comprises simultaneous removal of impurities as well as sizing of bacterial polysaccharides using an acid instead of conventional mechanical sizin...

ABSTRACT METHODS FOR SIMULTANEOUS FRAGMENTATION AND PURIFICATION OF BACTERIAL POLYSACCHARIDES The present disclosure relates to alternative, cost effective, rapid and simple methods for bacterial capsular polysaccharide (CPS) manufacturing resulting in 1) simultaneous sizing and purification of CPS 2) high CPS ...

Abstract PROCESS FOR PRODUCTION OF STRESS PROTEIN AND IMMUNOGENIC COMPOSITION COMPRISING THE SAME The present disclosure relates to an improved method for enhanced, stable expression and purification of stress protein (such as HSPs) or a stress protein-peptide complex isolated from a microbial pathogen, where...

Stable lyophilized immunogenic compositions comprising inter alia live attenuated recombinant flaviviruses, more preferably live attenuated recombinant dengue viruses, atleast one carbohydrate, atleast one amino acid and is particularly amenable to rapid freeze-drying treatments wherein, the composition preserves de...

A method for assaying unconjugated protein in a carbohydrate-protein conjugate composition The present disclosure provides a method for evaluating unconjugated or free protein in a polysaccharide-protein conjugate composition (test sample) wherein the unconjugated or free protein is Tetanus toxoid (TT). The said me...

The present disclosure relates to the field of improved liquid based multivalent polysaccharide–carrier protein (CP) conjugate vaccine composition and methods for manufacturing such vaccine composition comprising atleast at least two antigen selected from a group consisting of Salmonella typhi saccharide-CP conjugat...

IMPROVED METHODS FOR POLIOVIRUS INACTIVATION, ADJUVANT ADSORPTION AND DOSE REDUCED VACCINE COMPOSITIONS OBTAINED THEREOF The present invention relates to method for producing vaccine composition containing alum adsorbed reduced-dose Inactivated Polio Virus (IPV) antigens selected from the group comprising of type 1...

The present disclosure relates to vaccine compositions comprising pneumococcal polysaccharide-carrier protein conjugates. The present disclosure particularly relates to improved, stable, immunogenic multivalent Streptococcus pneumoniae polysaccharide-protein conjugate vaccine compositions having at least three disti...

The present disclosure relates to alternative, cost effective, rapid and simple methods for bacterial capsular polysaccharide (CPS) manufacturing resulting in 1) simultaneous sizing and purification of CPS 2) high CPS yield, 3) improved CPS purity and removal of protein and nucleic acid contaminants, 4) CPS with pre...

The invention describes an efficient platform for antibody manufacturing and formulation that provides i) cell culture process with improved feeding strategy resulting in high antibody titer between 2 gm/L to 5 gm/L; ii) improved purification process showing optimal percentage recovery, high purity monomer conten...

ABSTRACT IMMUNOGENIC COMPOSITIONS AGAINST ENTERIC DISEASES AND METHODS FOR ITS PREPARATION THEREOF Immunogenic composition for prophylaxis against infections caused by Salmonella and Non-typhoidal Salmonella infections and processes for its preparation is disclosed levels. The immunogenic composition comprises of...

The present invention relates to stable, immunogenic combination vaccine(s) comprising a mixture of antigens for prevention and prophylaxis of infections caused by Rotavirus, Poliomyelitis virus, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and Hepatitis B virus. The ...

The present invention relates to an improved process for purification of bacterial capsular polysaccharides, more specifically capsular polysaccharides of gram negative bacteria. The process comprises of concentration and dia filtration of harvest, treatment with anionic detergent and strong alkali followed by centr...

The present disclosure relates to field of lyophilized/freeze-dried viral combination composition/formulation and methods for manufacturing and obtaining the composition comprising at least three live attenuated virus selected from a group of Coronavirus, Measles virus and Rubella virus; and stabilizers comprising o...

The present disclosure provides a process for assaying stability of monovalent and/or multivalent, liquid and lyophilized polysaccharide protein conjugate vaccine compositions using HPLC-SEC method. The method provides stability analysis (lot to lot) of polysaccharide protein conjugate vaccine with respect to aggreg...

The present disclosure provides a method for quantifying low level of unconjugated or free monomeric protein in a polysaccharide-protein conjugate bulk (test sample); wherein the polysaccharide-protein conjugate bulk comprises high molecular weight molecules, aggregate, monomer, dimer, trimer, low molecular weight m...

METHOD FOR MANUFACTURING RECOMBINANT TRANSFERRIN BINDING PROTEINS AND VACCINE COMPOSITIONS COMRPISING SAME The present disclosure relates to manufacturing transferrin binding proteins. Specifically, the present disclosure relates to a simple, scalable, commercially viable fermentation and purification process for o...

The present disclosure relates to field of lyophilized/freeze-dried viral vaccine composition and methods for manufacturing and obtaining the vaccine composition comprising live attenuated flavivirus as vaccine antigen selected from a group of yellow fever virus, dengue virus, Japanese encephalitis (JE) virus, Kunji...

METHOD FOR MANUFACTURING VIRAL VACCINES AND COMPOSITIONS THEREOF Present invention provides a method of producing clarified virus pool of virus to obtain a lyophilized/freeze-dried live attenuated virus immunogenic composition/ formulation comprising atleast one or more than one antigens/immunogens. Present inventi...

ABSTRACT MENINGOCOCCAL PROTEIN BASED VACCINE FORMULATIONS AND METHODS FOR MANUFACTURING THEREOF Present invention provides fusion proteins with desired reduction in factor H binding, particularly the present invention provides optimized manufacturing process for fusion 5 proteins and formulations comprising the...

METHOD FOR QUANTIFICATION OF AN INGREDIENT USED IN VACCINE MANUFACTURING & FORMULATIONS The present disclosure relates to a method for quantification of a vaccine constituent, buffering agent or ingredient content in vaccine formulations or vaccine manufacturing processes. Particularly, the present disclosure relat...

ABSTRACT The present disclosure relates to determining potency of biological products such as therapeutic proteins and antibodies by bio-analytical methods. In some embodiments, the disclosure provides a method for determining potency of monoclonal antibodies (mAbs) or charge variants of monoclonal antibodies (m...

The present invention relates to the construction of Adenovirus-based vectors und to their use for inducing a broad, robust and durable cellular and humoral immune response in a subject.

ABSTRACT “A METHOD FOR DETECTING AND QUANTIFYING TARGET BIOLOGICAL AGENT” The present disclosure relates to a platform technology for analysing target biological agent based on lateral flow assay (LFA) in a biological sample using a serial dilution approach. The present disclosure determines and semi-quantifies...

ASSAY FOR DETERMINATION OF FUNCTIONAL IMMUNITY AGAINST SALMONELLA ABSTRACT The present invention relates to the field of Serum Bactericidal Activity (SBA) assay for 5 Salmonella spp., particularly S. Typhi and S. Paratyphi for determining the functional antibody titre. The improved SBA assay of the present inventi...

The present disclosure relates to a method for separation and/or quantification of free polysaccharide and/or total polysaccharide content in the monovalent polysaccharide protein conjugate bulk or multivalent conjugate vaccine composition. Particularly, the present disclosure relates to a method involving separatio...

ABSTRACT NOVEL REFERENCE STANDARD AND IMPROVED METHOD FOR QUANTIFICATION OF SACCHARIDE IN VACCINE The present disclosure relates to a method for quantification of total polysaccharide as well as free polysaccharide content in a conjugate bulk or vaccine composition by spectrophotometry or colorimetry. Colorimetry ...

The present disclosure provides a process for purification of bacterial polysaccharides, particularly Salmonella polysaccharides, the process comprising: acid hydrolysis; concentrating and diafiltering the cell harvest; treating the solution having polysaccharide with Sodium acetate, SDS, and Ethanol; centrifuging a...

ABSTRACT SACCHARIDE COUPLED MICROSPHERE, METHODS OF PREPARATION & APPLICATIONS THEREOF The present invention relates to an improved non-covalent (electrostatic) coupling of polysaccharides to microspheres to form couples where structure of saccharides remains unaffected/intact and retaisns epitope confirmation...

A METHOD OF MANUFACTURING INACTIVATED VIRAL VACCINE COMPOSITIONS THEREOF ABSTRACT The present invention relates to a method of manufacturing an inactivated viral vaccine that provides desired vaccine wherein complete virus inactivation occurs along with optimum virus recovery, less impurities and said process i...