Biopharmaceutical Development & Research Manufacturing
Health Biotech Research Centre's (HBRC's) scientists use Quality-By-Design (QbD) tools at early as well as late stages of formulation development. Use of Design of experiments (DOE) along with risk assessment strategies helps us to design our experimental plan which is scientifically valid and targeted for completion within our delivery timelines.
Contract Process Development Services :Process Development for small molecule, injectables and biologicsLaboratory scale, pilot scale, cGMP clinical trial materials and cGMP commercial scaleProcess optimization,Technology transfersFORMULATION DEVELOPMENT
Formulation development for injectable andlyophilized products (clinical to commercial)Process development, optimization and upstream / downstream processingLab & pilot scale process developmentTest batches manufacturing for stability studies, test and analysisClinical packaging & labelingHBRC has team of expert scientist with rich experience inbiotechnology, pharmaceuticals andnanobiotechnology,synchronized for successful development of technology and finish formulations. HBRC's scientists have extensive multinational expertise developing formulations for conventional and specialized dosage forms, including sustained (SR) & modified release (MR) solids, liquids, and injectables. Pharmaceutical finished formulation are developed keeping in view product stability, compatibility and patient compliance in custamarized way following Quality by Design (QBD) approach. All of the formulation are designed and developed for techno-economical feasibility and commercialization success. Before prototype development exhaustive pre-formulation studies are performed for characterization of the Active Pharmaceutical Ingredient (API) with excipients.
Quality by Design (QBD) Program
Define Target Product Profile (TPP)Critical Quality Attributes (CQAs) are determinedExtensive theoretical and literature surveyRisk assessmentControl strategy for sensitive products (moisture/oxidation)Lyophilization cycle (recipie) standardizationAnalytical Services:-
Analytical method development, optimization, validation and comparability studiesReference standard establishment and storageStability managementProduct characterizationImpurity profiling and related forced degradation studiesAnalytical capabilities(Product Related Impurities) :-
Charge related impurities- by Ion exchange chromatography and zeta potentialSize related impurities- by SEC and Non-reducing SDS-PAGEDegraded protein- by reducing SDS-PAGEOxidized and reduced impurities- by RP-HPLCFunctional group analysis by NMR and FTIRMicrobiology related analysis:-
Bio-burdenSterilityBETMICMBCTime kill curvePROJECT MANAGEMENT
HBRC's experienced project managers are pharmaceutical scientists, life scientist and biotechnologist. In coordination with manufacturing staff they are capable of ensuring your project timelines and expectations. They takes the lead on your development project, from pre-formulation, drug formulation development to clinical trial material (CTM) manufacture keeping you informed every step of the way.