Ph.D.-qualified licensed Pharmacist and biotechnologist with extensive expertise in Biological Evaluation Report for Medical Device as part of EU-MDR 2017/745, Gap Analysis for EU MDR 2027/745 and ISO 10993 test standards. Biocompatibility, Extractable and Leachable (E&L) and toxicological risk assessment (TRA) for the final finished medical devices. CMR/ED assessment for the Raw materials and final finished medical devices. Skilled in Raw material characterization and risk assessment. Expertise in Manufacturing, Packaging and Sterilization risk assessment for the final finished medical devices. Familiar with Regulatory affairs for pharmaceutical and cosmeceutical products. Skilled in ISO 10993-1,17,18:2018, nitrosamine impurities, PFAS, and DMF content analysis, I specialize in various pharmaceutical product development, characterization, and CTD documentation. Backed by a strong research background, I ensure compliance and safety in line with global regulatory standards.
Biocompatibility assessment
Toxicological risk assessment
ISO10993-1,17,18 : 2018
Nitrosamine impurities
PFAS DMF content
CTD Documentation
Regulatory affairs on Pharmaceutical and Cosmeuticals
Cell culture: Chondrocytes isolation from cartilage, Bone marrow stem cell isolation, Cytotoxic assay, Cryopreservation, Flow cytometry, Fluorescent microscopy
Molecular Biology: DNA, RNA isolation, PCR, Competent cell preparation Agarose gel electrophoresis, Primer design
Tissue Engineering: Scaffold preparation in various forms including porous matrices, film and hydrogels
Nanotechnology: Preparation of nanoparticles eg chitosan, gold and physicochemical characterization
Bioprocessing: Microbial cell culture, Production of enzymes in flasks or small-scale bioreactors
Protein Separation and Purification: PAGE, Western Blot, Ultra and Micro Filtration
Analytical Techniques: HPLC, FPLC, FT-IR, SEM, DSC/TGA, UV-VIS spectrophotometry
Formulation development of various solid dosage forms such as Tablets, Capsules, Paraenterals, and Semisolids
Animal studies: Wound healing and tissue regeneration in rodent models
Dr. Sasikala Chinnappan, Head, Department of Pharmaceutical Biology, Faculty of Pharmaceutical Sciences, UCSI University Kuala Lumpur, sasikala@ucsiuniversity.edu.my, +603 - 9101 8880 (Ext: 2246), +60186653642,
Dr.C.Rose, Chief Scientist (Retd), Dept of Biotechnology, CSIR-CLRI, Adyar, Chennai, TN, India, Chellanrose@yahoo.co.in, +91444462356