SIGNIFICANCE OF PHARMACEUTICAL FACTORS ON SELECTION OF BIOBATCH

Biobatch is usually prepared for the purpose of pharmacokinetic evaluation before NDA or IND filing. There are several critical issues that one has to face during the audit process like equivalence between the Biobatch and proposed commercial production batch. During the development and scale-up of the manufacturing process, various standard operating processes have to be documented to provide link between the bio/clinical batch and commercial batch. The Biobatch is a key component of the quality assessment, regardless of whether there is a bio waiver supported by dissolution studies or a formulation comparison, or bioequivalence study. IVIVC is one of the methods accepted by regulatory authorities including USFDA and it is applied while preparing the Biobatch. Extensive pilot experiments are to be carried out before a Biobatch is prepared. This may increase the cost of production for the company. Further, even after the approval of the formulation, various pharmaceutical factors may vary and lead to inconsistencies during the production phase. Recently, to overcome these problems, several software are available. Judicious use of the comprehensive software coupled with suitable in-vitro testing may provide an economical solution for the preparation of a Biobatch. Among various software ‘Gastroplus’ is one of the best software  that predicts the absorption pattern, pharmacokinetics, and pharmacodynamics for drugs administered via intravenous, oral, ocular, and pulmonary routes in human and preclinical species and may become must alternative for Bio studies.