Biotech Innovation Lanka Claimed

Offers consultancy in biotechnology for the pharmaceutical industry. Our consultancy specializes on:

• Biosimilars, glycosylated proteins/monoclonal antibodies
• API development and production (from lab scale to market)
• Technology transfer (not only for biosimilars) from Europe to Asia and vice versa
• Mammalian cell culture and down-stream processing, final bulk analysis and product release
• GMP protocols
• Intravenous solutions (from saline to complex mixtures)

We are practical oriented, hands-on company. Patient safety is our priority maxim: if you cannot give the infusion to your child, it is not a safe product! Quality – not only on paper – is our mission statement. We are aware of the complexity of modern API production. We look deep into process development for stable product quality and process robustness, up-scale opportunities, as well as full compliance to regulatory affairs (FDA, EMA, WHO).

Our Services

OUR EXPERTISE’S IN BIOTECH-GMP CONSULTANCY

• Biosimilar development (from lab scale to market)
• Support for USP, DSP, Analytics.
• Process development (GMP in mind) Process optimization, robustness, quality
• Technology transfers from Europe to Asia and vice versa
• Planing/setting-up of Production Facilities for IV solutions
• GMP conform documentation (design/writing/review of SOP’s, validation plans/reports etc.)
• Support for GMP audits (from authorities or execution of external audits)

CONSULTANT ACTIVITIES FOR BIOSIMILARS

• Analysis of Reference Medical Product (RMP)
• Cell banking (generation/testing/release of MCB, WCB, EPC and PPC)
• USP, DSP development, up-scale, engineering batches, HCP generation
• Development of specific analytics: HCP ELISA, hDNA assay etc.
• Virus clearance study
• Establishment and characterization of reference/working standards
• Stability studies (DS, DP, RMP)
• Formulation development
• API production (DP toxicology study material, process validation, DP manufacturing)

FURTHER CONSULTANCY SERVICES

• Routine production: data interpretation, trends, trouble shooting
• Optimization of process robustness and efficiency
• Up-scale opportunities
• URS, IQ, OQ, PQ for downstream equipment
• Validation issues
• API storage, shipment
• SOP review