Pharmaceutical Development & Manufacturing
We supports cGMP finish formulation development/product manufacturing with sterile fill and finish, with separate process development laboratory, filling, lyophilization and finish to support production of biopharmaceuticals. 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.Whether you are seeking a new formulation, involved in life-cycle management, manufacturing process improvement, or transferring manufacturing to a new site, HBRC’s scientists at Health Biotech Limited can meet your needs.
Contract Process Development Services
- Process Development for small molecule, injectables and biologics
- Laboratory scale, pilot scale, cGMP clinical trial materials and cGMP commercial scale
- Process optimization
- Technology transfers
Services offered are as follow:
HBRC has team of expert scientist with rich experience in biotechnology, pharmaceuticals and nanobiotechnology, 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.
- Formulation development for injectable and lyophilized products (clinical to commercial)
- Process development, optimization and upstream / downstream processing
- Lab & pilot scale process development
- Test batches manufacturing for stability studies, test and analysis
- Clinical packaging & labeling
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. It eliminates potential formulation, manufacturing, scale up, and instability issues. All of the quality and regulatory approval factors are considered at each stage of formulation development for successful commercialization.
Quality by Design (QBD) Program
- Define Target Product Profile (TPP)
- Critical Quality Attributes (CQAs) are determined
- Extensive theoretical and literature survey
- Risk assessment
- Control strategy for sensitive products (moisture/oxidation)
- Lyophilization cycle (recipie) standardization
We offers excellent analytical services biopharmaceutical products to support your development and marketed-product needs. We are equipped with state- of-the art analytical equipment required for routine testing, complete characterization of biopharmaceuticals. Our experienced staff possesses an in-depth understanding and regulatory knowledge. We provide quality services and data at affordable cost.
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.