A step-by-step cell culture process may improve the quantity and quality of cell replacement therapies.
一種逐步之細胞培養過程，可以提高細胞替代療法的數量及品質。
Insulin administration is the current mainstay of type 1 diabetes therapy, but it requires frequent injections and monitoring to provide patients with glycemic control. As cell therapies gain traction in the clinic for different disease states, researchers aim to optimize this approach for future diabetes treatments.
施予胰島素，是目前第1型糖尿病治療的主要方法。不過，需要頻繁注射及監測，來提供患者的血糖控制。隨著細胞療法，在不同疾病狀態的臨床中，獲得牽引(關注)。研究人員們力圖最佳化此方法，來供未來糖尿病療法之用。
Scientists are looking into islet transplantation as a promising alternative to insulin injections, primarily by creating islet-like cells from human pluripotent stem cell (hPSC) cultures.
科學家們正進行研究胰島移植，作為胰島素注射一種有指望的替代方案。主要藉由，從人類多能幹細胞(hPSC)培養物中，產生胰島樣細胞。
Differentiating stem cells into high-quality insulin-producing cells on a large scale for therapeutic manufacturing is a common bottleneck in translational research.
將幹細胞大規模分化成高品質之產生胰島素的細胞，來供治療之製造用，在轉移之研究中，是常見的一個瓶頸。
In a study published in Stem Cell Research & Therapy, a team of diabetes researchers led by Timothy Kieffer at the University of British Columbia investigated ways to improve scalable manufacturing and demonstrated key parameters for monitoring quality during cell therapy production.
在一項由加拿大英屬哥倫比亞大學，Timothy Kieffer領導的一支糖尿病研究團隊，發表於《幹細胞研究暨療法》期刊的研究中，調查研究了，於細胞療法生產期間，改進可擴展製造的方法且證實了，細胞療法生產過程中，監控品質的關鍵參數。
Their work provides insights for the larger-scale production of hPSC-derived pancreatic cells and suggests ways to standardize the manufacturing process.
他們的研究提供了，有關大規模生產，衍生自hPSC之胰臟細胞的洞察力。且提出了，標準化製造過程的方法。
The researchers applied a quality-by-design approach, which interrogates the experimental process as part of drug development rather than only testing the properties of the final product. They used this approach to investigate and improve insulin-producing cell manufacturing.
此些研究人員應用了一種，詢問實驗過程，來作為藥物開發的一部分，而不只是測試最終產品特性之品質源於設計的方法。他們使用了此方法，來調查研究及改進產生胰島素之細胞的製造。
“In this instance, the process is the product as well, because what we are doing and how we are doing it could impact the quality of the cells that are being made,” explained Priye Iworima, a bioprocess engineer from Kieffer’s laboratory who spearheaded this work.
來自帶頭開展該項研究之Kieffer實驗室的生物製程工程師，Priye Iworima解釋：「在此情況下，過程也是產品。因為，我們正在做的事情及我們如何做，會影響正在製造的細胞品質。」
Iworima and her colleagues developed and optimized a seven-step cell manufacturing process that differentiates hPSC into insulin-producing islet-like clusters.
Iworima及其同僚們開發並最佳化了一種，可將hPSC分化成，產生胰島素之胰島樣簇之七步驟的細胞製造過程。
At each differentiation step, they characterized bioprocess parameters such as cell proliferation, glucose consumption and lactate production rates, and cell fate biomarkers.
在每一分化步驟中，他們描繪了，諸如細胞增殖、葡萄糖消耗與乳酸酶產生率，及細胞宿命生物標記等，生物製程參數。
The researchers enhanced cell yield by adjusting the cell culture process, and they revealed a gradual metabolic shift from glycolysis to oxidative phosphorylation that scientists can monitor as a quality control metric during scalable manufacturing.
藉由調整細胞培養過程，此些研究人員提高了細胞產量。而且他們揭露了一項，科學家們能在可擴展製造期間進行監視，作為品質控制衡量指標之從糖酵解到氧化磷酸化的逐漸代謝變化。
“This paper is interesting in that it fills in a gap,” said stem 細胞生物學家Joe Zhou Weill Cornell Medicine, who investigates organoid-derived cell replacement therapies for diabetes and who was not involved in this study. “In terms of how you scale production or do quality control, how do you industrialize a cell therapy from the lab toward the clinic? We see very few publications like that in this field.”
未參與該項研究，來自美國威爾康奈爾醫學院，進行調查研究衍生自類器官之細胞，供糖尿病作為替代療法的細胞生物學家，Joe Zhou宣稱：「該論文是引人注目的，因為它填補了一處空白。有關如何擴大生產或進行品質控制，如何使細胞療法，從實驗室產業化到臨床？在此領域中，我們很少看到類似上述的刊物。」
Iworima believes that her findings will also help researchers evaluate whether intermediate cell products are useful for certain subsets of patients, which could shorten and simplify the manufacturing process.
Iworima認為，她可能縮短及簡化製造過程的發現，也將協助研究人員們，評估居間的細胞產品，是否對某些患者子群有用。
“Eventually, we will have different cell products that may be best suited to the individual, whether it is the more terminally differentiated islet-like cluster, or whether it is the pancreatic progenitor,” Iworima said.
Iworima宣稱：「最終，我們將擁有可能是最適合個人的不同細胞產品。不管是較末端分化的胰島樣簇，還是胰臟源祖細胞。」
Previous transplant studies with diabetic rodent models suggested that progenitor cells may be adequate for mature beta cell function postimplantation. The quality control parameters highlighted along the step-by-step process in this study could facilitate future translational applications for progenitor cells and fully differentiated cells alike.
先前諸多以糖尿病之囓齒動物模型的移植研究暗示，源祖細胞或許滿足植入後，成熟之β細胞功能的需求。於此研究中，按照逐步製程強調的品質控制參數，一樣可能促進源祖細胞及完全分化之細胞，未來的轉移應用。
If scientists can overcome in vitro manufacturing barriers such as scale and quality control limitations, cell culture methods for growing insulin-producing islet mimics may help diabetes cell replacement therapies reach patients.
倘若科學家們能克服，於體外製造的諸多障礙，諸如規模及品質控制等限制。那麼用於培養產生胰島素之胰島模擬物的細胞培養方法，可能有助於使糖尿病細胞替代療法及於患者。
“The journey of a laboratory protocol from the bench to bedside—people always talk about that. But most of the papers are about the bench,” Zhou said. “It will be good to have this knowledge out there so people do not have to reinvent the wheel. It will be very helpful.”
Zhou宣稱：「人們總是談論，一種從試驗台到臨床之實驗室治療方案的歷程。不過，此些大多數是有關試驗台上的論文。在那裡，擁有此知識會是可靠的，這樣人們就不必無謂地重複。這會是非常有幫助的。」
網址：https://www.the-scientist.com/making-moves-toward-cell-therapy-for-diabetes-71659
翻譯：許東榮
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