“Making every pill exactly right”

Pharmaceutical companies are transitioning to continuous flow manufacturing, using digital technologies to deliver consistent quality at lower costs

Throughout my career in the chemical industry, I’ve been amazed to learn about the transformation of our chemical manufacturing processes through digital technology innovations. What used to be the manual loading of dangerous chemicals at imprecise levels has shifted to charging precisely measured raw materials with the push of a button. Quality testing that historically required manual sampling and testing has been replaced with in-process sensors that can report on many metrics continuously throughout processing.

Although the internet-of-things has enabled well-established operations for the continuous flow manufacturing of chemicals, the pharmaceutical industry’s adoption of continuous manufacturing over the same time period was limited by technological immaturity1.  In the highly regulated pharmaceutical industry where safety is of utmost importance, and where healthcare payers are imposing cost constraints, adopting digital technologies could lend itself to improving real-time quality control throughout the supply chain and reductions in costs.

According to BioPharm International, “the Food and Drug Administration (FDA) has been a strong supporter of continuous processing as early as 20041”, with the FDA reporting opportunities for achieving consistent quality, lower costs, and increased productivity2. Advancements in technology, regulatory support and competitive pressures are advancing the industry forward. Johnson & Johnson (J&J) is the first to receive FDA approval for switching from batch to continuous flow manufacturing, utilizing sensors within the production equipment to continuously monitor product quality, ultimately driving to make every pill exactly right (3). Further down the supply chain, J&J continues to monitor the product between processing and the consumer, utilizing in-product sensors to monitor temperature-sensitive medicines4. For the longer-term, J&J is taking the supply chain a step further, exploring the opportunity to continue monitoring their products once inside the human body4.

Given varying production requirements and demand across drugs, I imagine that not all drugs will be manufactured via continuous flow; however, I forsee that big data collected from these processes can prove valuable for other drugs, and recommend that Johnson & Johnson extrapolate insights that they can apply to improve the quality and safety of batch-manufactured drugs. As more data is collected, I can’t help but wonder whether pharmaceutical companies will find themselves better positioned to commercialize products faster. Backed by their capabilities to control variability in the final product, will they will be able to prove the efficacy of drugs in a more controlled way?

 REFERENCES

1Hernandez, Randi. “Continuous Manufacturing: A Changing Processing Paradigm.” BioPharm International. N.p., 10 Nov. 2017. Web. 14 Nov. 2017. <http://www.biopharminternational.com/continuous-manufacturing-changing-processing-paradigm>.

2Chatterjee, Sharmista. “FDA Perspective on Continuous Manufacturing.” The Food and Drug Administration. Proc. of IFPAC Annual Meeting, Baltimore. N.p., Jan. 2012. Web. 14 Nov. 2017. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM341197.pdf

3O’Marah, Kevin. “Smart Manufacturing Is Ready to Take Off.” Forbes. Forbes, 06 Oct. 2016. Web. 14 Nov. 2017. <https://www.forbes.com/sites/kevinomarah/2016/10/06/iot-and-supply-chain-precision/2/#55f461214233>.

4Blanchard, Dave. “The Healing Power of the IoT.” IndustryWeek. N.p., 16 May 2017. Web. 15 Nov. 2017. <http://www.industryweek.com/supply-chain/healing-power-iot>.

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4 thoughts on ““Making every pill exactly right”

  1. Continuous flow production is an exciting innovation for pharmaceutical companies. To the extent that this can lower cost, I hope that these cost savings can be passed along to the end consumer; especially for high volume drugs, like Lipitor, that are a relatively low cost ($10,000 for a course of treatment).

  2. Amy, thank you for the wonderful post!

    As we discussed in the Embril case, another challenge for the pharmaceutical industry is the uncertainty in initial demand when bringing a drug to market, as forecasting in this early stage is very difficult. A faster process allows the companies to respond more rapidly to changes in demand while shielding them if the demand remains low. This digitization also helps companies cut costs because these processes involve smaller facilities, less energy, and less raw materials. [1] As costs become lower, the medicines can be commercialized more effectively in international markets. [2] This yields an optimum outcome: cheaper, more effective drugs for the people who need them.

    [1] https://www.technologyreview.com/s/506511/breakthrough-offers-a-better-way-to-make-drugs/
    [2] https://communities.acs.org/community/science/sustainability/green-chemistry-nexus-blog/blog/2017/06/22/continuous-flow-chemistry-s-role-in-providing-greater-access-to-medication-around-the-world

  3. Amy, great article! I think the introduction of continuous flow manufacturing, together with other digital innovation to ensure consistent quality along the production line, has the potential to change pharmaceutical companies for the better. This is a much-needed improvement in the pharmaceutical sector, given the many scandals that saw major companies recalling drugs or even closing production plants due to quality concerns. Johnson & Johnson (J&J) itself recalled a high number of drugs over the course of time, with damaging consequences from a reputational and monetary perspective.[1],[2]
    On top of that, continuous production will also enable a better use of resources, with reduced material waste and machine downtime, that will result in higher production and lower costs. This increased efficiency will also benefit final consumers, as they will have access to greater volumes – possibly at a lower price.

    At the same, I believe there are many obstacles to the scalability of this solution. First of all, regulatory challenges persist. The FDA approval is on a drug by drug basis and it seems to be quite a long and stringent process, as even the industry leader J&J received the greenlight for only one product – its HIV drug Prezista.[3]
    A second challenge entails the high coordination needed within the entire supply chain – from equipment suppliers to API and excipient manufacturers. A third one is about the high capital investment needed to convert the production and to set up the required mechanism of quality control.[4]

    Given such challenges I imagine the introduction of continuous production will require some time. Nevertheless, it will definitely be a game changer with time, enabling consistent upsides for both producers and consumers.

    [1] Reuters, “Timeline: Johnson & Johnson’s product recalls”, February 2012.
    https://www.reuters.com/article/us-johnsonandjohnson-timeline/timeline-johnson-johnsons-product-recalls-idUSTRE81L01K20120222
    [2] Reuters, “Tylenol maker to pay $25 million for selling metal-contaminated drugs”, March 2015.
    https://www.reuters.com/article/us-johnson-johnson-tylenol/tylenol-maker-to-pay-25-million-for-selling-metal-contaminated-drugs-idUSKBN0M629S20150310
    [3] Pharmatech.com, “FDA Approves Tablet Production on Janssen Continuous Manufacturing Line”, April 2016.
    http://www.pharmtech.com/fda-approves-tablet-production-janssen-continuous-manufacturing-line
    [4] Pharmatech.com, “Continuous Manufacturing: A Generic Industry Perspective”, May 2017.
    http://www.pharmtech.com/continuous-manufacturing-generic-industry-perspective

  4. So this is kind of mind-blowing: “For the longer-term, J&J is taking the supply chain a step further, exploring the opportunity to continue monitoring their products once inside the human body.”

    This whole idea of technology suddenly allowing a company to ‘follow’ its product over the entire lifecycle of its product is both exciting and worrisome for things like drugs. I suppose this isn’t necessarily a novel concept — lots of firms follow the effectiveness and performance of their products once they are in the hands of final consumers (e.g. smartphones, automobiles with computer systems, etc.). However, what’s really interesting about this concept as it’s applied to drugs that a firm would have to collect (either explicitly or implicitly) biometric data of the drug’s final consumer. This seems like both massively advantageous for drug development efforts and also incredibly invasive in terms of personal privacy.

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