Main Chemistry Research Articles

Scale-up and scale-out: what do we really need and how will we get there?

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://bioinsights.blob.core.windows.net/uploads/Thirkettle colour 2020 copy.jpg" data-image="1"></div><div class="author-det"> <b>Jan Thirkettle</b> is Chief Executive Officer of Transine Therapeutics, UK based biotech developing SINEUPs (a novel lncRNA platform which upregulates protein expression) in ocular and neurodegenerative diseases. He was previously Chief Development Officer at Freeline, a clinical phase AAV gene therapy company with a novel AAV capsid platform. Jan has extensive experience in the devel¬opment and commercialisation of novel platforms including NCEs, natural products, biologics and gene therapies, and has played a role in launching products in all these classes. Prior to joining Freeline Jan led the establishment of GSK’s Cell and Gene Therapy platform and was responsible for CMC/sup¬ply for Strimvelis, the first <i>ex vivo</i> gene therapy to receive an EU Marketing Authorisation Application. Jan holds an MA in Chemistry and a PhD in Biological Chemistry from Oxford University. </div></div></div>

Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://bioinsights.blob.core.windows.net/uploads/Thirkettle 200 x 200.jpg" data-image="1"></div><div class="author-det"> <!--StartFragment-->Jan Thirkettle is Chief Development Officer at Freeline, a clinical-phase AAV gene therapy company focused on the development of systemically delivered gene therapies for the treatment of chronic diseases. As such, Jan has responsibility for Programme Management and CMC/Manufacturing. Jan is a Director of the US, Irish and German Subsidiaries. Jan has extensive experience in the development of novel manufacturing platforms including natural product and enzyme-derived NCEs, biologics and gene therapies, and has enabled the launch of medicines in all of these areas. Prior to joining Freeline Jan led the establishment of GSK’s Cell &amp; Gene Therapy platform and was responsible for CMC/supply for Strimvelis, the first ex vivo gene therapy to receive an EU Marketing Authorisation Application. He has held pharma industry positions spanning from discovery to commercial manufacturing, but is most passionate about the cross-functional elements of late-state development and new platform deployment. Jan holds an MA in Chemistry and a PhD in Biological Chemistry from Oxford University.<!--EndFragment--> </div></div></div>

Interview With Richard H Guy

Richard Guy received an MA in chemistry from Oxford University (Oxford, UK), and his PhD in pharmaceutical chemistry from the University of London (London, UK). He has held academic posts at the University of California, San Francisco (CA, USA), and the University of Geneva (Geneva, Switzerland). In 2004, he joined the University of Bath (Bath, UK) as Professor of Pharmaceutical Sciences. Professor Guy‘s research focuses on skin barrier function characterization, transdermal drug delivery, enhancement of percutaneous absorption, iontophoresis, noninvasive biosensing and the prediction and assessment of skin penetration and topical bioavailability. Interview conducted by Hannah Coaker, Assistant Commissioning Editor