Displaying 1–25 of 40 results for PAT

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The Drug Industry at a Crossroad: PAT's Role

(Whitepaper)

In this 6-page PDF document, author Efraim Shek asserts that PAT is part of a new paradigm whose time has come, and suggests how PAT can become more the rule than the exception.

The Business Case for PAT

(Whitepaper)

Having trouble justifying PAT projects to top management? The business drivers for PAT are compelling, both on the regulatory and on the financial side. This Rockwell Automation white paper discusses how to conduct a "productivity improvement appraisal" and how to handle discovery and analysis ...

Raman 101: A Primer for In-Situ PAT

(Whitepaper)

For in-situ PAT, Raman spectroscopy has advantages over Near-IR and Mid-IR. This technical note by Kaiser Optical Systems discusses Raman’s suitability for PAT applications and lists specific application opportunities.

Engineering Standards Advance Pharmaceutical PAT

(Whitepaper)

Manuel Hormaza, CEO of IBS Caribe, discusses process understanding and management, and the engineering standards that promise to bring plug-and-play capabilities to PAT.

Optimize Bioreactor Design with PAT

(Whitepaper)

This article outlines how PAT can be used to monitor bioreactors, and how this real-time monitoring was achieved by integrating advanced process control tools into the Simatic PCS 7.

Implementing PAT and QbD? Real-time Particle Size Measurement for the ...

(Whitepaper)

As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release - the realization of a transformed way of working. This article reviews changing practice ...

Using PAT in Risk-Based Development and CMC

(Whitepaper)

This July presentation by Professor Kenneth R. Morris, Purdue University's Department of Industrial and Physical Pharmacy, discusses the use of PAT in a risk-based approach to drug development and CMC.

PAT Answers: FDA's Final Guidance

(Whitepaper)

FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative.

The State of PAT in the Pharmaceutical Industry

(Whitepaper)

Pavilion Technologies’ recent survey of major manufacturers reveals divergent strategies between the U.S. and Europe, and mixed opinions about how broadly PAT should be defined. Quantitative and qualitative data are summarized here.

How MES Enables PAT

(Whitepaper)

A Manufacturing Execution System provides a framework for PAT, allowing for enhanced productivity and quality, says Joseph Vinhais, vice president of regulatory compliance at Camstar Systems.

Taming the Data Monster: Practical Guidance on Implementing PAT

(Whitepaper)

A new applications document from Automsoft summarizes the IT requirements for PAT, focusing on data management issues.

Using PAT for Crystallization and Drying

(Whitepaper)

In this article, Zhihong Ge and colleagues from Merck Research Labs discuss how they used PAT to monitor asymmetrical hydrogenation, crystallization and API drying.

Kick–Starting PAT to Achieve Quality by Design in cGMP Bioprocessing

(Whitepaper)

Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product–centric one. Yet, many pharma and biopharma companies have failed to incorporate that approach into their strategic plan. This white paper explains the new distinctions and what they mean ...

Achieving Manufacturing Process Excellence with Quality by Design, Design ...

(Whitepaper)

Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the ...

PAT: The Value of Better Control

(Whitepaper)

Process Analytic Technology (PAT) provides pharmaceutical manufacturers with an opportunity to use the latest Advanced Process Control (APC) tools to better understand and control process variability. Learn the keys to successful PAT projects and how you can use them to turn data into knowledge, ...

PAT Needs and Applications in the Bioprocess Industry

(Whitepaper)

In this comprehensive report, the authors examine what PAT means in practice for the biotechnological manufacture of pharmaceuticals. They analyze regulatory issues, monitoring methods and available technologies, and compare their findings against the needs for monitoring in bioprocess-based ...

Standards for Pharmaceutical Applications of PAT

(Whitepaper)

This presentation by Don Marlowe, FDA Standards Coordinator in the Office of the Commissioner, outlines the ASTM E-55 Committee's efforts in developing PAT standards for pharmaceutical applications.

Applying PAT to Crystallization

(Whitepaper)

Crystallization processes pose challenges to manufacturers who seek to apply process analytical technologies (PAT), but progress is being made. This paper, from FDA's Center for Drug Evaluation and Research, discusses the challenges and provides some examples of how they're being addressed.

PAT application: At-line TOC for Cleaning Validation and Product Changeover

(Whitepaper)

The Food and Drug Administration's 2004 PAT guidance document for improving pharmaceutical manufacturing efficiency and quality discusses using at-line methods for data collection. This application note from GE Analytical Instruments demonstrates the applicability and capability of at-line total ...

Aseptic PAT and Particle Monitoring — from Snapshots to Continuous Feedback

(Whitepaper)

Particle monitoring is critical for maintaining aseptic conditions, but portable counters won’t help develop trending data. In this white paper, Mark Hallworth, pharmaceutical manager for Particle Measuring Systems, discusses continuous monitoring methods, how they’re evolving, and why they’re ...

NIR-based PAT Replaces HPLC for Bottling

(Whitepaper)

This application note from Uhlmann VisioTec discusses NIR spectroscopy, offering some insights into how it was used to replace HPLC analysis at a pilot-scale pharmaceutical suspension bottling line.

PAT and Pharma Competence

(Whitepaper)

This Guide to Process Analytical Technology analyzes the industry’s needs and discusses Siemens' multidisciplinary approach to meeting them.

Using PAT to Optimize Cell Culture for Monoclonal Antibody Development

(Whitepaper)

Ache Stokelman and colleagues on Amgen’s Global Process Science Team outline how they used BioProcessors Corp.’s SimCell platform to improve results.

Control Particle Size, Polymorphic Form and Blending

(Whitepaper)

This applications note by the contract research firm SSCI Inc. provides an overview on how PAT can be used in pharmaceutical solids processing.

Online Reaction Monitoring of Inprocess Manufacturing Samples by UPLC

(Whitepaper)

Process Analytical Technology (PAT) is a critical component in manufacturing, relied upon to ensure product quality and improve process yields. In this white paper, Waters Corp. discusses the use of novel Waters technology for online reaction monitoring of inprocess manufacturing samples, which ...

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