Scale Up

Jul 02, 2016
Pharmaceutical Technology
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
May 31, 2016
PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.
May 02, 2016
Pharmaceutical Technology
Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.
Apr 02, 2016
Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.
Apr 02, 2016
Pharmaceutical Technology
Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.
Mar 02, 2016
Pharmaceutical Technology
Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.
Jul 01, 2015
PharmTech Multimedia
By Pharmaceutical Technology Editors
Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.
Apr 02, 2015
Pharmaceutical Technology
Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.
Dec 08, 2014
By Pharmaceutical Technology Editors
Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.
Aug 01, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.
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