Trends and new process analytical technologies in pharmaceutical manufacturing
Sijun Wu1, Yang Liu2, Xudong Fan3
1Institute of Pharmaceutical Informatics, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China; State Key Laboratory of Chinese Medicine Modernization, Zhejiang University, Hangzhou 310058, China.
International Journal of Pharmaceutics
|July 11, 2025
Summary
Process Analytical Technology (PAT) enhances pharmaceutical and food quality control by improving efficiency and cost-effectiveness. This review details PAT applications and emerging trends for better manufacturing and safety.
Area of Science:
- Analytical Chemistry
- Chemical Engineering
- Food Science
- Pharmaceutical Sciences
Background:
- Ensuring consistent quality and safety of pharmaceuticals and foods is critical for human health.
- Process Analytical Technology (PAT) is increasingly adopted in pharmaceutical manufacturing and Food Safety assessments.
- PAT offers enhanced operational efficiency and cost-effectiveness over traditional analytical methods.
Purpose of the Study:
- To comprehensively review the applications of PAT in key industries.
- To detail the latest PAT methodologies and their principles.
- To discuss emerging trends and practical requirements for PAT development.
Main Methods:
- Review of spectral information-based PAT methodologies.
- Analysis of physical information-based PAT techniques.
- Exploration of sensor array-based and microfluidic-based PAT approaches.
- Case study analysis of PAT implementation.
Main Results:
- PAT is effectively applied in oral solid dosage and biopharmaceutical manufacturing.
- PAT significantly contributes to Food Safety assessments.
- Categorization and detailed analysis of four main PAT methodology types were provided.
Conclusions:
- PAT offers significant advantages for quality control in pharmaceutical and food industries.
- Understanding diverse PAT methodologies aids in selecting appropriate analytical techniques.
- Emerging trends in PAT development align with practical industry needs, promoting wider adoption and continuous improvement.
Keywords:
Biopharmaceutical manufacturingFood SafetyOral solid dosage formProcess analytical technologySensorSpectroscopyMore Related Videos
07:48A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
Published on: September 22, 2011
22.4K
09:56Real-time Monitoring of Reactions Performed Using Continuous-flow Processing: The Preparation of 3-Acetylcoumarin as an Example
Published on: November 18, 2015
9.8K
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
178
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
178
00:57High-Performance Liquid Chromatography: Instrumentation
2.1K
High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.
2.1K
01:21Development of Analytical Methods
722
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
722
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
195
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
195
01:26Drug Administration and Therapy Phases: Overview
764
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
764
01:21Tandem Mass Spectrometry
1.2K
Tandem mass spectrometry is a technique that uses multiple mass analyzers in series to obtain a higher selectivity and signal-to-noise ratio for the analyte. Instruments with multiple analyzers separated by an interaction cell enable secondary fragmentation and selected study of the fragment ions.
Secondary fragmentations occur in the interaction cell and can be induced by various factors. Fragmentation induced by collision with inert gases, such as N2, Ar, He, etc., is called collision-induced...
Secondary fragmentations occur in the interaction cell and can be induced by various factors. Fragmentation induced by collision with inert gases, such as N2, Ar, He, etc., is called collision-induced...
1.2K