At the center of ingenuity is knowledge, and knowledge is power. Our Analytical Development Laboratory team is skilled at designing analytical methodologies to generate key findings around every step of your process, giving you increased insight and control over every stage in your product’s journey.
Our team of experienced scientists has a proven track record of developing and optimizing analytical methods to measure process performance at any stage on your path to commercialization. We identify your product-specific needs and create a tailored testing plan with procedures that can be transferred and optimized for quality control. At Cytovance, we also have developed several platform methodologies which can be leveraged to decrease method development time and accelerate product characterization.
At Cytovance, we work closely with your team to design testing plans and execute robust mammalian analytical development methods for your specific product. We focus on identifying the best methods to provide in-depth insights on your molecule that will help to streamline the regulatory process as you go into late-phase operations. With an exciting combination of expertise and instrumentation, we can achieve the early product insights you need to make critical long-term decisions.
Cytovance has the capabilities to perform or provide guidance around all of the necessary steps on the journey from drug product discovery to commercialization. Our skilled team can provide assistance on analytical method development and method transfer no matter what stage. We can also qualify and validate all required analytical methods according to the ICH guidelines on Validation of Analytical procedures: Text and Methodology Q2(R1).
To protect your invested time and resources, we offer an inhouse range of cold storage chambers to support reference standard (RS), drug substance (DS) development, and drug product (DP) development stability programs. With temperature chambers that span 40C, 25C, 5C, -25C, and -80C we can help manage and complete the stability data packages you need to have confidence in your product as it moves through our processes.
Complete mammalian clone selection, clonal stability, and banking services tailored to your requirements.
Take your productivity to the next level with our process development experts.
Benefit from our full-service CGMP facility from cell banks to production with up to 2,000L capacity.
