Creating highly productive cell lines requires a great level of care that starts with细胞系开发。Envigo’s Rook Khajenouri and Richard Druckerunderstand the challenges客户面临整个过程。他们最近讨论了一些常见的产量问题，并提供了确保的解决方案consistent and reliableresults that enhancedantibody production。
Tip 1: Maintain sample integrity
抗体制作与细胞储存温度和污染的最基本可预防的问题。
Improper storage of samples in facilities and during shipping between facilities can cause temperature fluctuations that can stress the cells. Stressed cells can greatly hamper antibody production, requiring intensive efforts to get cell lines back up to optimal production levels. Strict control of samples during shipment can helpensure the optimal temperature is maintained both from facility-to-facility, and within the process。
Contamination withmycoplasmaand other adventitious agentshas become less of an issue over the last 30 years, but it still remains a problem.当污染发生时并不总是显而易见的，但是一旦细胞培养物开始恶化，它就会大大影响生产by altering the behavior and metabolism of the cells. Well-documented laboratory procedures (including any partner laboratories), the purchasing of tested media and supplements from reputable sources, along with proper segregation of cells and equipment can all help to minimize the potential for contamination.
提示2：验证和记录更高的返回
随着公司的持续兼并和买断，克隆通常销售，继承或通过，但可能缺乏完整的监护链。因此，可行的细胞系可以具有很大的承诺和商业潜力，但对于其发展和历史而言，通常是知之甚少。
鉴于生物系统并不总是如预期执行，并且可能具有不可预测的制造行为，公司需要确保他们不断捕获必要的文件，并验证其克隆符合预期的必要文件。Keeping and maintaining complete records can help avoid downstream issuesduring production and help keep timelines on track.
提示3：促进耐心等下游生产
一些细胞系最初开发快速开发，以回答短期项目的研究问题。然后，随着时间的推移，细胞系变得有价值，并评估其商业潜力。但if cells were created rapidly or chosen improperly to ensure optimal production, their yield may be compromised.在这种情况下，小区线将需要大量的额外时间和精力来最佳地执行，或者客户端将留下可能提高其生产成本的单元线。
在这些情况下，实验室的耐心是一种真正的美德。Envigo recommends from the very start that scientists allow for the time necessary to develop their lines and proactively plan for a long-term strategy for the cells. Knowing that a cell line may eventually be commercialized will help drive development and can help select the right development partners that are capable of quickly scaling up to production levels.
提示4：评估潜在发展伙伴的属性
Whenselecting a partnerto help develop your antibodies, it is important to考虑他们的历史，灵活性和能力。一家经过验证的曲目记录的公司应具有适当的质量保证控制和SOP。询问显示其重现流程的能力，以确保一致的流程。
Flexibility is another factor that may influence your decision making. Some development partners require that their clients follow strict internal protocols, while others are able to offer a custom process that is flexible and can adjust to the client’s specific needs.
Capacity is also important, particularly on the体内侧面，确保项目可以快速扩展。许多公司可以处理几次一次性或小项目，但是当涉及需要准备好的动物模型的劳动密集型项目时，您需要一个可以快速满足需求的合作伙伴。
提示5：建立强大，持续的沟通
Once a development partner is selected, it’s important to share as much information as possible upfront. Let your partner know the ultimate goal for the product. For example, is this production just a pilot for feasibility? Is this for a product that will eventually be scaled up to meet market demands? Will this become a licensed product that requires cGMP or other specific regulatory requirements? These details help the development partner design for scalability and prepare to gather crucial data needed for downstream submissions.
Timely, proactive communication is also needed from the development partner to keep their clients informed of any issues as well as progress. For example, if a client is expecting purified material in 6-8 weeks but the development partner is observing issues with the material, they need to quickly report any issues and manage the client’s expectations.
Custom antibody productionwill always have its challenges, but with a proactive strategy in place to avoid common pitfalls, you can increase your chances for success. You can also learn more by reading other real lifesuccess stories为了帮助您确定您的抗体产品应该是什么样的。
Depending on the ultimate application of your antibody, one should begin with an open-mind and give consideration to whether polyclonal or monoclonal antibodies are the best fit for your application.
Read more in our white paper:抗体优化
