It is essential that the drug substance is safe and effective for its intended use. Process optimization and validation play a pivotal role in ensuring its quality.
Process optimization
Process optimization focuses on enhancing the efficiency and atom economy at every stage of its development. Through analysis and redesigning of processes we eliminate unnecessary steps, reduce waste, and increase the overall output. A dedicated team continuously evaluates and improves processes using a data-driven approach and advanced technologies.
Process validation
Our quality assurance and validation team work together on data from the process design stage through to commercial production to ensure that manufacturing processes consistently deliver quality products from batch-to-batch and unit-to-unit. We adopt three key process validation stages:
The key to a robust process design is thorough appropriate documentation and evaluation. It consists of two elements: designing the facility and qualifying the equipment and utilities, as well as conducting process performance qualification (PPQ). We use DoE studies, risk analysis tools and verification runs at lab or pilot scale. Together these help us predict performance of commercial scale processes. The pilot plant consists of identically equipped manufacturing blocks and MOCs (Management of Change) which enable smooth tech transfer of molecules. We also provide a genotoxic impurity evaluation and nitrosamine impurity assessment to help customers right from the early phase of their project.
Process qualification assesses the data gathered from all relevant studies, including experiments, lab-, pilot- and commercial batches. Successful qualification demonstrates that commercial manufacturing processes will perform as expected.
We have systems in place to detect any nonconformities in processes enabling us to constantly improve or optimize strategies, even if this means additional regulatory approval or further process validation.
Technology transfer
Neuland has the scientific knowledge and technical support to ensure efficient and seamless tech transfer of products. We implement careful forward planning and execution to help avoid any unnecessary disruptions or delays. Our process involves a systematic approach that begins with a thorough evaluation of the technology to be transferred. This includes a comprehensive assessment of the existing manufacturing process, equipment, and quality control methods.
Neuland’s scientific and project management team works closely with customers to identify any potential gaps or challenges that may arise during the transfer process. We also provide regular updates, enabling collaborative manufacturing decisions for projects in the plant.
Quality by Design (QbD) and Design of Experiments
In the R&D laboratory, Neuland’s scientific team applies rigorous scientific and engineering tools and methodologies, using QbD principles, risk management strategies, and DoE software to understand and control processes. QbD applied to process development and scale-up focuses on five main issues: safety, quality, environment, health, and economics.
To support our QbD approach we have a Process Engineering (PE) Laboratory, equipped with state-of-the-art instrumentation and automation, and operated by highly qualified engineers and chemists trained in the best practices of QbD and DoE. We use Minitab and Design Expert as DoE software platforms. Based on experiments to identify the critical quality attributes (CQAs) of an API and the critical process parameters (CPPs), our scientists create a robust design space with flexibility built in to maximize accuracy and reproducibility on scale-up and transfer to a manufacturing facility.
Particle engineering
At Neuland, we understand the importance of API particle size towards product bioavailability, efficacy, and shelf-life. The process engineering team uses PAT tools to develop a robust process for API. We provide customers with comprehensive PSD, BD TBD and other relevant data required for pre-formulation studies.
Based on customers’ requirements, our particle engineering team performs milling and micronization studies and checks the impact on the PXRD and other physical and chemical properties. Other studies, such as exploration of different drying techniques, are part of the optimization plan. Temperature excursions studies for the drying period and RPM studies are performed to understand the impact on any polymorphs. Using microscopic images, crystal morphologies are studied during the process optimization phase.
Analytical Development & Validation
Phase Appropriate Development
