Salvatore Carmisciano

Salvatore Carmisciano, Msc.

Salvatore Carmisciano graduated from the Faculty of Chemical Engineering in Roma.

He joined Novartis vaccines in 2010 working as formulation expert in the fields of Drug Product process and formulation development.

In 2013, Salvatore joined Sandoz Austria working as Drug Product Leader being responsible on project process characterization and down scale model concepts.

In 2017, he joined the Novartis Drug Product Development Slovenia as Senior Scientist leading technical transfer/validation activities and supporting projects submission. He advised drug product leaders and Scientists inside Novartis Drug Product Development organization for studies, concepts and procedures regarding liquid and freeze-dried sterile products.

In 2018, he moved to the position of Head Project and Process Sciences in the Novartis Drug Product Development organization by managing pharmaceutical (drug product) development projects and leading late phase development team of scientists.

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2nd Annual Pharmaceutical
Lyophilization Summit 2020

Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring, new products development.

12 Feb 2020
Berlin, DE
Pharma

Day 2: Thursday, 13 February 2020

CASE STUDY: Lyophilization cycle development and scale-up for recipe conditions where Rp changes as function of shelf temperature.

Lyophilization is a complex process including several stages (freezing, primary and secondary drying).The selection of process conditions for each lyophilization step is extremely important with regards to the overall cycle duration and product quality attributes (e.g. appearance).

By using a mathematical modelling approach which requires measuring the heat transfer coefficient (Kv) and resistance to mass flow (Rp), the design space is constructed to predict the primary drying duration and maximum product temperature. Lyophilization recipe is then selected based on the defined design space. Conventionally, the approach used for the design space calculation takes into account that Rp change over time is not a function of the shelf temperature in the design space area.

The case study elaborates a model-assisted development and scale up of a lyophilization cycle with primary drying conditions where the temperature of the shelf exceeds the glass transition temperature (Tg’) and Rp over time is changing as a function of shelf temperature due to microstructural cake changes known as ‘cake micro-collapse’.

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