Technically Speaking

Read articles written by our team of industry experts on topics in pharmaceutical and biopharmaceutical manufacturing.

Disrupting the Industry: G-CON’s Impact on Cell and Gene Therapy Manufacturing

Dennis Powers, Vice President of Sales Engineering and Business Development

In this issue of Technically Speaking, we bring to you a special Q and A with G-CON’s Vice President of Sales Engineering and Business Development, Dennis Powers. With over 25 years of experience working in the biopharmaceutical industry, Dennis answers questions about the POD’s effect on therapeutics with off-site manufacturing of modular/podular cleanrooms and G-CON's overall impact on the cell and gene therapy sector for manufacturing advanced therapies in prefabricated cleanrooms.

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Facility of the Nuture – Part I

Thomas J. Piombino, Vice President, Biotechnology Process Architect IPS

We would like to thank special guest author, Tom Piombino of IPS for contributing to this edition of Technically Speaking. Tom is a well-recognized expert in process architecture and process design for mAbs, gene therapy, cell therapy/CAR-T and vaccines. We are delighted to have him contribute his latest thinking on facilities.

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Delivery of the First POD to Europe... Achieved with Flying Colors

Mark Taylor, Director of Engineering and Project Management

In late 2018, G-CON began working with a global pharmaceutical company whose goal was to scale up their manufacturing operations in the US and Europe for an approved CAR-T product. Specifically, the client was establishing internal lentivirus production capabilities, starting with a fast-track clinical facility at the one of their existing sites. In addition to the demand for clinical capabilities, a 200L commercial operation was also required. Both projects were schedule driven. The client chose G-CON’s POD technology for the clinical portion due to its higher probability of success in schedule driven projects.

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The Importance of Reduced and
Predictable Project Timelines

Dennis Powers, Vice President of Sales Engineering and Business Development

Reducing project schedules and completing facility projects on time has never been more important to our industry than it is today. It is critical that drug manufacturers have the capability of and capacity for producing therapies and treatments that are needed by patients around the world. With the spotlight on the new cell and gene therapies that are being launched, and their effectiveness for curing life threatening diseases, the importance of well-controlled project timelines using pre-fabricated modular facility solutions continues to grow.

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Evolution of the POD: A Decade
Inside the Box

Pete Makowenskyj, Director of Sales Engineering

In 2019, G-CON Manufacturing celebrated its 10 year anniversary and what an amazing 10 years it has been. G-CON has been at the forefront in industry, leading the way in prefabricated cleanroom solutions. Throughout this time, G-CON has been known for their POD technology which is an autonomous cleanroom technology. However, what some are not yet aware of is how far our technology has progressed over those 10 years.

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