Process R&D (PRD)

Familiarization:

Our diligent replication of conditions specified by you, ensures an accurate evaluation of process repeatability. From concentration to temperature, each parameter is replicated, establishing the foundation for subsequent optimization and enhancement efforts.

Development:

During the development phase, we carefully determine parameter ranges and optimal conditions, including temperature, time, pH, and reagent equivalents and perform thorough crystallization studies to meet stringent specifications for yield, conversion, purity, and other Critical Quality Attributes (CQA). Leveraging Design of Experiments (DoE), process modelling, and other state of the art tools, we identify and validate optimal values of critical process parameters, enhancing conversion rates and yields, minimizing by-product formation and ensuring process robustness which is essential for our “Right first time” approach.

Sustainability:

Green practices drive efforts to minimize solvent usage, solvent toxicity, mitigate extreme reaction conditions, and reduce process times whenever possible. That’s why we at Porton Pharmatech prioritize striking a balance between meeting product specifications and minimizing waste generation and energy consumption.

Route scouting:

At Porton Pharmatech, we evaluate the strengths and weaknesses of a designated Route of Synthesis (RoS), considering its practicality and viability. Comprehensive analyses encompass all goals, costs, and risks, providing insights into the cost-value ratio and potential success. Feasibility assessments guide decisions on whether to proceed, redesign, or abandon the specified RoS, ensuring informed choices in pharmaceutical development.

Starting material (SM) qualification:

It is a common practice to test the same starting material produced by different manufacturers. As a result of different production processes from different manufacturers, the same starting material often has different properties (overall purity, type of impurities particle size, etc.) which can significantly impact the quality of the produced intermediates and final product. Use tests are therefore essential for selecting the appropriate manufacturer and specifying (both qualitatively and quantitatively) the Critical Mass Attributes of starting materials to obtain the final product within set specifications.

Quality By Design:

Here in Porton Pharmatech we guarantee the exceptional quality of our products, placing high priority on the discovery, evaluation, and control of risks that may occur in the research stage and manufacturing process. We strive to understand the relationships between the product’s critical quality attributes, critical mass attributes and critical process parameters that influence them. Our proactive approach yields a robust process in which the product can consistently meet all required specifications. This is achieved through experimentation, process modelling, statistical analysis and risk assessment.

Impurity identification and purification:

Investigations on Route of Synthesis (RoS) include the understanding of process-related impurities such as intermediates, side products, mutagenic impurities, residual solvents and elemental impurities. Supported by the analytical department, here at Porton Pharmatech we are able to:

• Synthesize and characterize the required impurities
• Screen for actual and potential side products
• Screen for methods to purify the final target substance