When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. In Part 1 of a two-part article, Mike Cooper of Pharmatech Associates discusses exporting U.S.-manufactured material to foreign markets leveraging a certificate of pharmaceutical product (CPP) issued by the FDA.
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The new normal created by the recent COVID-19 pandemic has created disruptions in many sectors of life sciences. In the case of vaccine development, pairing SIA with digital twin modeling can provide invaluable insight into whether your equipment has the necessary capabilities to accept the process.
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Pharmatech’s Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part series in BioProcess Online. In part one, she details the biosimilar development path. Part two discusses how to prepare for your meetings with the FDA.
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Pharmatech’s Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part article in BioProcess Online.
In part one, she details the biosimilar development path. In the second part of the article discusses what–and when–to present research findings and how to prepare for your meetings with the FDA.
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In the CPhI Annual Report for 2020, Bikash Chatterjee, CEO of Pharmatech Associates, said the concept of patient centricity has gone beyond being a buzzword to being a core value and that telemedicine will have a long-lasting impact. Chatterjee also foresees the industry will see voice collection of data in the home begin to be incorporated into both home and health settings.
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We are deeply saddened to announce the unexpected passing of Warren G. Baker, CEO of Pharmatech Associates. While we mourn the passing of an inspriational leader, a succession plan was in place and announce the appointment of Mr. Bikash Chatterjee as CEO.
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What The DMF?! Industry and FDA
Ultimately, the change of oversight from CDER to CBER will affect all past, present, and future biologic-related master files and marketing applications/approvals. It will be interesting to observe how much CBER will honor past CDER reviews and approvals, and how much sponsors will have to re-defend already approved submissions and regulatory strategies.
Jennifer Markarian interviewed Bikash Chatterjee for Pharmaceutical Technology’s June 2020 Equipment and Processing Report:
Manufacturers are adapting with virtual work, remote monitoring, and re-evaluation of facility design to ensure worker safety.
Bikash Chatterjee and Adam Lambert of Pharmatech Associates weigh in with fellow industry experts on developing and manufacturing controlled release products, in the latest issue of American Pharmaceutical Review.
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“People tend to think of continuous manufacturing as something that you have to do only on a large-scale, with metric tons of material, but the reality is you can do it at small scale and have exquisite control” – Bikash Chatterjee, Pharmatech Associates
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