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Institute for Bioengineering and Biosciences
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Today’s Pharma and Biotech Projects: A Phased Approach

Today’s Pharma and Biotech Projects: A Phased Approach | iBB | Scoop.it

The general outline of a pharma or biotech engineering project includes phases and tasks that typically span 2–3 years. The concept of phased engineering, procurement, and construction (EPC) is revisited in a paper co-authored by José Cardoso Menezes from BERG-iBB and colleagues and published in Pharmaceutical Engineering. The concept is further updated with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects.

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Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry | iBB | Scoop.it

The book "Multivariate Analysis in the Pharmaceutical Industry", co-edited by José Cardoso Menezes from BERG-iBB in collaboration with colleagues Ana Patrícia Ferreira and Mike Tobyn from Bristol-Myers Squibb has just been released by Academic Press. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Click on title to learn more.

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Advanced Qualification of Pharmaceutical Excipient Suppliers

Advanced Qualification of Pharmaceutical Excipient Suppliers | iBB | Scoop.it

Pharmaceutical excipients have different functions within a drug formulation and can influence the manufacturability and/or performance of medicinal products.  Sometimes it may be necessary to qualify a second supplier, but its product will not be completely equal to the first supplier product. In a recent study co-authored by José Cardoso Menezes from BERG-iBB, Multivariate Analysis is used to extract relevant information  from Raman spectroscopy, laser diffraction and Xray powder diffraction analysis of calcium hydrogen phosphate from two suppliers. The two lots of CaHPO4 could be discriminated by their supplier and the  gained knowledge made it possible to specify an enhanced strategy for second supplier qualification. Click on title to learn more. 

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Opportunities in Continuous Manufacturing of Large Molecules

Opportunities in Continuous Manufacturing of Large Molecules | iBB | Scoop.it

Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) is made in a paper co-authored by José Cardoso Menezes from BERG-iBB and colleagues and published in Pharmaceutical Engineering. The article briefly reviews continuous biomanufacturing (CBM) at a time of very high and global demand for vaccines as well as increased demand for cell and gene therapy products.

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José Menezes Co-Edits "A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry"

José Menezes Co-Edits "A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry" | iBB | Scoop.it

The book "A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry", co-edited by José Cardoso Menezes from BERG-iBB in collaboration with colleagues Nuala Calnan (St. Gallen University), Martin Lipa (Merck) and Paige Kane (Merck) has just been released by CRC Press. The book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence. Click on title to learn more.

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IFPAC-2016: International Forum on Process Analytical Technology

IFPAC-2016: International Forum on Process Analytical Technology | iBB | Scoop.it

Process Analytical Technology is one of the most exciting and important advanced technology areas meeting both the current challenges, as well as the future needs of industry. The thirtieth International Forum Process Analytical Technology (IFPAC-2016), which will take place in Arlington, Washington DC (24-27 Jan 2016), will cover the latest trends and real-life applications in the fields of Quality by Design, Process Analytical Technology, Quality Metrics, Continuous Manufacturing and Process Control applications for the pharmaceutical, biotechnology, generic, chemical, petrochemical, food, and related industries. The Scientific Board of IFPAC 2016 is co-chaired by Prof. José Cardoso Menezes from BERG -IBB. Click on title to learn more.

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