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Leahy D.K.,Bristol Myers Squibb | Tucker J.L.,Amgen | Mergelsberg I.,Merck And Co. | Dunn P.J.,Pfizer | And 2 more authors.
Organic Process Research and Development | Year: 2013

The authors of this concept article are members of the IQ Green Chemistry working group, one of many subgroups of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) which has been officially chartered in April 2010. The IQ Green Chemistry Working Group seeks to drive innovation and the awareness of green chemistry in pharmaceutical development through the establishment and adoption of best practices, sharing of information within peer networks, and collaboration with regulatory agencies and other key stakeholders. © 2013 American Chemical Society.


Thomson N.M.,Pfizer | Singer R.,Pfizer | Seibert K.D.,Eli Lilly and Company | Luciani C.V.,Eli Lilly and Company | And 5 more authors.
Organic Process Research and Development | Year: 2015

A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control strategies that are required in order to ensure process performance and product quality. Control through process, method, and/or model design can combine to form a holistic control strategy that effectively manages risk and assures quality for the patient. A typical drug substance control strategy overview is presented, along with a number of detailed case histories that aim to demonstrate the use of process design and the development of methods and modeling to ensure control of critical quality attributes where appropriate, whether in the final drug substance or through upstream controls. © 2015 American Chemical Society.


Faul M.M.,Amgen Inc. | Argentine M.D.,Eli Lilly and Company | Egan M.,Infinity Pharmaceuticals Inc. | Eriksson M.C.,Boehringer Ingelheim Pharmaceuticals | And 7 more authors.
Organic Process Research and Development | Year: 2015

Designation and justification of an Active Pharmaceutical Ingredient Starting Material (API SM) is an important aspect of the drug development and commercialization process and defines the point at which the GMP manufacturing process starts (ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients). In 2014, the API SM Working Group of the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium or IQ), composed of representatives from the Active Pharmaceutical Ingredient and Analytical Leadership Groups, published two manuscripts on API SMs that provided (1) a review and industry perspective of the regulatory guidances that support designation and justification of API SMs, and (2) a summary of current practices across member companies of the IQ Consortium on designation and justification of API SMs based upon a survey completed by the IQ member companies. The information and data presented in these manuscripts provided a thorough overview of current practices but more importantly revealed the absence of a universal approach within the pharmaceutical industry to justifying API SMs. Using the information from manuscript 1 and 2, this manuscript, which represents part 3 of the topic series, will provide a guiding framework that is based upon the principles described in ICH Q11 and which includes relevant experiences of the IQ member companies, for the justification of a proposed API SM to the regulatory agencies. © 2015 American Chemical Society.


Purohit V.C.,Chemical Process Research and Development | Allwein S.P.,Chemical Process Research and Development | Bakale R.P.,Chemical Process Research and Development
Organic Letters | Year: 2013

An efficient, catalytic hypervalent iodine-mediated oxidative 1,2-shift of 1,1′-disubstituted olefins is described. This methodology provides concise access to homobenzylic ketones with electron-donating substituents. In the case of cyclic systems, this transformation results in ring-expanded β-benzocycloalkanones, which are useful for further elaboration. © 2013 American Chemical Society.


Chen J.,Chemical Process Research and Development | Przyuski K.,Chemical Process Research and Development | Roemmele R.,Chemical Process Research and Development | Bakale R.P.,Chemical Process Research and Development
Organic Process Research and Development | Year: 2014

In the development of a new route to bendamustine hydrochloride, the API in Treanda, the key benzimidazole intermediate 5 was generated via catalytic heterogeneous hydrogenation of an aromatic nitro compound using a batch reactor. Because of safety concerns and a site limitation on hydrogenation at scale, a continuous flow hydrogenation for the reaction was investigated at lab scale using the commercially available H-Cube. The process was then scaled successfully, generating kilogram quantities on the H-Cube Midi. This flow process eliminated the safety concerns about the use of hydrogen gas and pyrophoric catalysts and also showed 1200-fold increase in space-time yield versus the batch processing. © 2013 American Chemical Society.

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