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By Balaji Bharatwaj, Sai Chamarthy, and Keirnan Lamarche

Balaji BharatwajSai Chamarthy-finalKeirnanLaMarcheBased on current data, it is estimated that about 27% of revenue is allocated by pharmaceutical companies toward process development and manufacturing; in some instances, more is spent on manufacturing than research and development. Presently, batch production processes dominant in the pharmaceutical industry have several advantages that include equipment flexibility and greater quality control, while rife with issues like mixing scalability and low operational asset efficiency. These shortfalls can be mitigated by the use of continuous manufacturing, an approach that can address issues pertinent to cost and robustness in pharmaceutical manufacturing.

In recent years, the advent of improved computing power and capabilities have made modeling an integral part of the pharmaceutical manufacturing toolkit. Predictive process modeling approaches can supplant pricey experimentation-based process development, enhance the understanding surrounding process variability, and expand design-space exploration. Process modeling can aid greatly in the transition of existing batch manufacturing paradigm to the much sought after continuous manufacturing regimen. Furthermore, process modeling can be used to optimize manufacturing conditions, develop and assess control strategies, and ensure optimal design and operating conditions.

With the increased emphasis laid on quality by design (QbD) by regulatory agencies, the use of predictive modeling becomes useful as technologies like high-fidelity predictive modeling can be harnessed to define an optimum design space to ensure all critical quality attributes are met. Modeling and computational tools such as flowsheet simulations, computational fluid dynamics, population-balance models, and discrete element modeling (DEM) have been used to model solid dosage form behavior and in certain instances can contribute to the identification of critical process parameters to support quality risk assessments. The aforementioned traits have contributed greatly to the rise of modeling as an indispensable instrument of the pharmaceutical manufacturing armamentarium.

A day-long facility-sponsored AAPS workshop supported by the AAPS Process Modeling and Simulation (PMSFG) and Process Development (PD) focus groups will aim to shed light on the most current trends prevailing in the modeling space pertinent to manufacture of pharmaceutical dosage forms. The overarching theme will be to provide a scientific forum for members of the group and researchers to keep abreast with the recent research that is being conducted in the field of predictive process—more specifically surrounding the unit operations involved in manufacture of solid dosage forms ranging from particle sizing (drug substance phase) to dissolution (drug product phase).

Eminent speakers from reputed academic institutions, regulatory agencies, and pharmaceutical firms will share their most recent research accomplishments in the field of modeling and simulation of pharmaceutical manufacturing—keeping in line with the workshop’s theme. Modeling of unit processes like micronization, wet granulation, coating, and dissolution are some of the topics that will be discussed at length. A panel discussion and a networking session is also incorporated wherein attendees will have an opportunity to interact with the speakers further and provide input and feedback.

Tools for Accelerating Pharmaceutical Process Development will take place at Bristol-Myers Squibb, in Plainsboro, New Jersey, on June 1.

Sai Chamarthy, Ph.D., is an associate director at Merck, in Pharmaceutical Sciences & Clinical Supply, where he leads a group specializing in formulations, process development, and manufacturing of inhaled and nasal drug products.
Balaji Bharatwaj is a senior scientist at Merck & Co., Inc., working in respiratory product development. He is a formulation scientist currently working on development of metered dose inhalers, orally disintegrating tablets, and extended release polymeric dosage forms.
Keirnan LaMarche, Ph.D., is a senior research investigator for the Drug Product Science and Technology department of Bristol-Myers Squibb. He has worked on innovative approaches to formulation and process development for solid dosage forms at BMS since 2008.