Biopharmaceutical Development & Research Manufacturing

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.


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HEALTH BIOTECH LIMITED, a Contract Manufacturing Pharmaceutical Company launched and initiated together a modern Lyophilizer for injection.WHO GMP quality assurance procedures guarantee a peak performance of all products. With the assistance of latest equipments, the automated and modern production process has been prepared. We offer a complete range of services with prompt and reliable assistance for all our customers. We manufacture an extensive spectrum of brand pharmaceutical formulation products in almost any form. Importers, distributors, and agents are always welcome to help us to introduce our products in their national markets.

HEALTH BIOTECH LIMITED also provides attractive dossier licensing opportunities. Amongst the main activities, contract manufacturers of Injectables , Dry Liquid Injections, Ointments, Syrups, Capsules and Tablets are involved along with the production of HEALTH BIOTECH LIMITED’s own commercial range. Being fully independent pharmaceutical formulation company,HEALTH BIOTECH LIMITED offers flexible terms of trade and gives each customer a personal attention. Thanks to modern production line and WHO GMP standards, our products are of highest quality and yet reasonably priced.

Consequently, our large-scale production capacities, highly qualified production, and quality control staff, state of art WHO-GMP certified manufacturing facility combines to give a perfect environment for outsourcing or contract manufacturing pharmaceutical products. Kindly contact us for your requirements to enable us to give you our best rates. We offer our products on third party basis and under neutral label for export.
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