There has never been more investment and excitement around the cutting-edge medicine being developed under the umbrella of cell and gene therapies (CGT).聽聽is one of the fastest growing sectors of the life sciences industry. However, the processes to develop and scale these therapies comes with their own set of unique challenges. Often the science to develop a treatment is cutting-edge, but the聽operations聽to scale those treatments is stuck in the past.
Paper batch records hold back cell and gene therapy manufacturing
Eighty percent of life sciences manufacturers still use paper batch records, including CGT manufacturers. It must be said that while using paper hasn鈥檛 stymied progress 鈥� plenty of companies involved in聽聽have had success using this older model 鈥� it鈥檚 not the most efficient or cost-effective solution, especially if manufacturers intend to remain compliant with current good manufacturing practices (cGMP). Smart CGT manufacturers should be looking to upgrade to聽聽that better fit the innovative nature of their products.
Find a better digital manufacturing solution for 听别蹿蹿颈肠颈别苍肠测
Automation and digital connectivity are the ideal means to help cell and gene therapy manufacturers stick to cGMPs and maintain聽cell and gene therapy compliance. Most biopharmaceutical manufacturing facilities already rely on a wide range of automation solutions, like robotic instrumentation and platforms, to enhance their workflows, increase production, and reduce human error. However, the application of these to cell and gene therapies is still being established.
Some of the biggest hurdles still facing the cell and gene therapy production process include:
- Inconsistency in聽Cell and Gene Therapy manufacturing production processes, especially where manual handling is involved, and the risk of human error is high.
- The presence of inherent variables stemming from multiple donors and/or patients.
- The substantial onsite team size required to manage, produce, and oversee CGT manufacturing campaigns.
, have the potential to help with all of these.聽Cell and gene therapy EBRs聽are a big leap in the right direction because they can decrease human error, standardize value entry processes, connect teams in real time to speed up batch review, and much more.
To learn more about what digital solutions industry leaders are using to solve these issues, the current state of the聽cell and gene therapy manufacturers鈥� MES solutions, and how digitizing production processes can help you stay competitive in this fast-moving industry, download the free whitepaper below.
