View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
January 7, 2019

AAPS 2018: the future of continuous cell reactor manufacturing

The problem of continuous chromatography may soon be solved as proposals emerge to allow for continuous flow bioprocessing, according to a senior FDA expert. 

By GlobalData Healthcare

The problem of continuous chromatography – a barrier to true continuous manufacturing using cell reactors – may soon be solved as proposals emerge to allow for continuous flow bioprocessing, according to a senior FDA expert.

Free Report
img

What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
Enter your details here to receive your free Report.

Kurt Brorson, Lab Chief, Office of Biotechnology in Center for Drug Evaluation and Research (CDER) at the FDA, addressed large molecule production during a talk entitled “FDA Perspective: How Regulators Address Innovation” on November 7, 2018, at the AAPS meeting in Washington, DC. Brorson is part of the cross-functional Emerging Technology Program team at CDER, which is encouraging the industry to develop technologies that will move cell manufacturing from batch production to continuous processing.

Continuous manufacturing solutions are particularly needed for low-volume orphan and cell therapy products, this publication previously reported (B/POR, April 2018). FDA Commissioner Scott Gottlieb has stressed the importance of innovation in continuous manufacturing, and the agency’s FY2019 budget prioritises developing regulatory frameworks to help support continuous manufacturing platforms.

After continuous chromatography, the next hurdle for continuous manufacturing will be continuous viral clearances, Brorson said. This is because the longer running time of a continuous cell culture reactor will increase the chances of contamination with bacteria or viruses.

Once these hurdles in continuous bioprocessing are passed, the next question will be when to initiate continuous production: early on as part of an investigational new drug application (IND), or later in development to increase purity or drive up yield. From a regulatory view, the initial IND is the easiest and therefore the preferred time to implement a new technology.

Alternatively, companies could amend the IND between clinical phases if a change is needed in the process. If process changes are made after marketing approval, this would require a supplemental BLA application; regulatory requirements for these are severe enough that most sponsors do not undertake them “unless there is a clear economic or safety imperative,” noted Brorson.

Brorson said it will be “five to ten years” before fully linked truly continuous bioprocessing is possible. Continuous manufacturing trends have historically come to bioprocessing from the small molecule world, which is in turn informed by the petroleum chemistry industry, he added.

Brorson’s team reviews applications for emerging technology that would aid continuous bioprocessing. In cases where the technology is particularly novel or innovative, team members may schedule up to three 1–2-day visits to see the technology themselves, he said.

Related Companies

Free Report
img

What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology