Search
Search Results
-
Convolutional Neural Networks Guided Raman Spectroscopy as a Process Analytical Technology (PAT) Tool for Monitoring and Simultaneous Prediction of Monoclonal Antibody Charge Variants
BackgroundCharge related heterogeneities of monoclonal antibody (mAb) based therapeutic products are increasingly being considered as a critical...
-
Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review
Industry 4.0 has started to transform the manufacturing industries by embracing digitalization, automation, and big data, aiming for interconnected...
-
Phase-appropriate Application of Process Analytical Technology for Early Pharmaceutical Development of Oral Solid Dosage Forms—the Case Study of Uniformity Screening of Dosage Units and Blends
Process analytical technology (PAT) in late-stage drug product development is typically used for real-time process monitoring, in-process control,...
-
Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration
Control of single pass tangential flow ultrafiltration (SPTFF) is crucial for continuous manufacturing of monoclonal antibodies (mAbs). Integrating...
-
Revolutionizing Pharma: Prioritizing Industry 4.0 Implementation Challenges in the Indian Pharmaceutical Landscape Through Analytical Hierarchy Process Analysis
PurposeThe manufacturing industry is changing quickly because of trends like automation and high-volume customization. Industry 4.0 is a movement...
-
Analytical Quality by Design
QbD applied to analytical procedure development is termed as Analytical Quality by Design (AQbD). ICH Q14 encompasses the approach of AQbD....
-
Process Analytical Technologies (PAT) and Quality by Design (QbD) for Bioprocessing of Virus-Based Therapeutics
With the advent of modern virus-based therapeutics the need for new state-of-the-art virus manufacturing processes arose. Traditional virus vaccine...
-
Use of Resonant Acoustic Mixing Technology for Ultra-Low-Dose Blending in a Single-Step Mixing Process
PurposeTo evaluate the use of resonant acoustic mixing (RAM) technology for homogenous blending of a morphologically challenging model API in...
-
Effect of Manufacturing Conditions on Particle Characteristics in the Drug-Layering Process of a Novel Melt Granulation Technology, MALCORE®, Using a Design of Experiments
PurposeMALCORE ® , a manufacturing technology of drug-containing particles (DCPs) for coating, consists of a 2-step melt granulation process. The...
-
Application of Process Analytical Technology for Pharmaceutical Coating: Challenges, Pitfalls, and Trends
Coating process is a critical unit operation for manufacturing solid oral dosage forms. For a long time, the coating weight gain has been discerned...
-
Advancements of hot-melt extrusion technology to address unmet patient needs and pharmaceutical quality aspects
BackgroundHot-melt extrusion (HME) significantly affects pharmaceutical manufacturing by enhancing drug solubility and bioavailability. Advancements...
-
Continuous Manufacturing of a Polymer Stabilized Emulsion Monitored with Process Analytical Technology
Moving from batch to continuous manufacturing (CM) requires implementation of process analytical technology (PAT), as it is crucial to monitor and...
-
A review on-analytical tools in proteomics
BackgroundProteomics is an analytical technique employed for the identification and quantitative analysis of total protein content in a cell, tissue...
-
Analytical Quality by Design Fundamentals and Compendial and Regulatory Perspectives
Over the last years, the pharmaceutical industry and regulatory agencies have been embracing the Quality by Design (QbD) principles. Significant...
-
Metamorphosis of Twin Screw Extruder-Based Granulation Technology: Applications Focusing on Its Impact on Conventional Granulation Technology
In order to be at pace with the market requirements of solid dosage forms and regulatory standards, a transformation towards systematic processing...
-
Tableting process-induced solid-state polymorphic transition
BackgroundPolymorphism is that a substance exists into more than two crystalline forms with different molecular arrangements and/or conformations. It...
-
Analytical Target Profile (ATP) and Method Operable Design Region (MODR)
A fundamental piece of the analytical procedure lifecycle (APLC) approach involves the acquisition of understanding about total procedure variability...
-
Impact of Properties of Hydrated Silicon Dioxide as Core Material on the Characteristics of Drug-containing Particles Prepared by the 2-step Process Melt Granulation Technology, MALCORE®
Drug-containing particles (DCPs) are frequently used as cores in the development of solid oral dosage forms. The wet layering technique, which is a...
-
Analytical method development and dermal absorption of gallic acid, a hair dye ingredient
Gallic acid (GA) is a phenolic compound known as 3,4,5-trihydroxybenzoic acid. GA is used as a hair dye ingredient. It is limited to be below 4.0% in...
-
Analytical Quality by Design, Life Cycle Management, and Method Control
Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research and development, and to help control...
