Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing

2018 ◽  
Vol 9 (1) ◽  
pp. 253-281 ◽  
Author(s):  
Christopher L. Burcham ◽  
Alastair J. Florence ◽  
Martin D. Johnson
Keyword(s):  
Flexible Manufacturing ◽  
Process Development ◽  
Drug Product ◽  
Good Manufacturing Practice ◽  
Continuous Manufacturing ◽  
Continuous Processing ◽  
Pharmaceutical Ingredients ◽  
Regulatory Bodies ◽  
New Applications ◽  
Processing Steps

The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

Sensors for biomanufacturing process development: facilitating the shift from batch to continuous manufacturing

2018 ◽  
Vol 22 ◽  
pp. 115-127 ◽  
Author(s):  
Timothy R Holzberg ◽  
Valencia Watson ◽  
Sheniqua Brown ◽  
Abhay Andar ◽  
Xudong Ge ◽  
...  
Keyword(s):  
Process Development ◽  
Continuous Manufacturing

scholarly journals Impact of Quality Risk Management Process in Pharmaceutical Industry to Curtail the Non Conformity

2013 ◽  
Vol 11 (01) ◽  
pp. 74-82
Author(s):  
Aachchhadita Sharma ◽  
Raju Mari Jeyaprakash ◽  
Raju Mari Jeyaprakash ◽  
Rinchi Bora ◽  
Abinash Chandra
Keyword(s):  
Risk Management ◽  
Risk Mitigation ◽  
Drug Product ◽  
Management Process ◽  
Ground Rule ◽  
Quality Risk Management ◽  
Risk Management Process ◽  
Regulatory Bodies ◽  
Quality Risk ◽  
Risk Scale

Risk is intertwined with every drug product in a market. This article’s intent is to provide ground rule and praxis of different tools for Quality Risk Management (QRM) in various aspects of pharmaceutical science. QRM comprises of tools and processes which helps in establishing objectives. Hence they are also known as Enablers. Enablers help in risk mitigation of product quality throughout a lifecycle in such a way that benefit outweighs the risk. The key properties of Enablers or QRM, i.e., attempts made, solemnness and records shall be compatible with risk scale. The Enablers accomplishment gives recognized, obvious and steps of Enabler process produced by regeneratable methods which is based on customary comprehension to evaluate feasibility, ability to find out risk prejudice. The QRM or Enabler tools can assist the manufacturing company and regulatory bodies to scrutinize, handle, notify, and inspect the risk.

scholarly journals INTERNATIONAL EXPERIENCE OF PUBLIC ADMINISTRATION OF PRODUCTION AND TURNOVER OF MEDICINES IN UKRAINE

2020 ◽  
pp. 151-159
Author(s):  
Л. В. Котенко
Keyword(s):  
Health Care ◽  
Life Expectancy ◽  
Public Administration ◽  
International Cooperation ◽  
International Organizations ◽  
Good Manufacturing Practice ◽  
International Experience ◽  
Iso 9001 ◽  
Regulatory Bodies

The article forms the international experience of public administration of production and circulation of medicines in Ukraine. The role of international organizations in maintaining the health of the nation, increasing the level of labor productivity, as well as the quality and life expectancy of people is studied. The leaders of the European market of drug manufacturers have been identified. The international standard ISO 9001 and features of introduction of good manufacturing practice (GMP) are analyzed. The international cooperation for the regulatory bodies of the WHO member states is described in order to discuss ways to strengthen cooperation in the field of health care.

scholarly journals PROCESS DEVELOPMENT FOR PRODUCTION OF ACTIVE PHARMACEUTICAL INGREDIENTS WITH PICHIA PASTORIS

2007 ◽  
Vol 40 (4) ◽  
pp. 13-18
Author(s):  
R. Luttmann ◽  
M. Eicke ◽  
A. Kazemi ◽  
A. Ellert ◽  
B. Hahn ◽  
...  
Keyword(s):  
Pichia Pastoris ◽  
Process Development ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients

scholarly journals Reliable Characterization of Organic & Pharmaceutical Compounds with High Resolution Monochromated EEL Spectroscopy

Polymers ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1434
Author(s):  
Partha Pratim Das ◽  
Giulio Guzzinati ◽  
Catalina Coll ◽  
Alejandro Gomez Perez ◽  
Stavros Nicolopoulos ◽  
...  
Keyword(s):  
Organic Compounds ◽  
Drug Product ◽  
Amorphous Solid ◽  
High Energy ◽  
New Drugs ◽  
High Energy Resolution ◽  
Amorphous Solid Dispersion ◽  
Pharmaceutical Ingredients ◽  
Transmission Electron ◽  
Optical Region

Organic and biological compounds (especially those related to the pharmaceutical industry) have always been of great interest for researchers due to their importance for the development of new drugs to diagnose, cure, treat or prevent disease. As many new API (active pharmaceutical ingredients) and their polymorphs are in nanocrystalline or in amorphous form blended with amorphous polymeric matrix (known as amorphous solid dispersion—ASD), their structural identification and characterization at nm scale with conventional X-Ray/Raman/IR techniques becomes difficult. During any API synthesis/production or in the formulated drug product, impurities must be identified and characterized. Electron energy loss spectroscopy (EELS) at high energy resolution by transmission electron microscope (TEM) is expected to be a promising technique to screen and identify the different (organic) compounds used in a typical pharmaceutical or biological system and to detect any impurities present, if any, during the synthesis or formulation process. In this work, we propose the use of monochromated TEM-EELS, to analyze selected peptides and organic compounds and their polymorphs. In order to validate EELS for fingerprinting (in low loss/optical region) and by further correlation with advanced DFT, simulations were utilized.

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