Cell Culture Consulting Services

Early in a new drug development process, there must be the consideration that the drug will make it through pre-clinical testing and the clinical trial process successfully to the commercial stage and provide a benefit to the targeted patient population. For biologicals produced by mammalian cell culture, the process optimization and plan for potential commercial production should be begin early in the drug development process. Postponing the planning process can leave an organization vulnerable to a high cost-of-goods and capacity shortfall.

Proper planning can translate:

  • to huge cost savings- having time to choose optimal cell line and optimal process allows for minimization of cost-of-goods
  • increased speed to market- no unexpected delays
  • the ability to satisfy market demands after product launch


Offered in conjunction with an independent consultant, services that we offer can assist your company from the early stage of drug development to commercial production. This includes:

  • Cell line and Media Optimization
  • Optimal Process Selection (including process economic scenarios)
  • Bioreactor Process Optimization
  • Process Scale-Up
  • Process Validation

Cell Line and Media Optimization - One of the most important factors to maximize cell line productivity is media and cell line optimization. Before process development and scale-up, the process of cell line screening and identification of a robust, stable and high producing cell line is a critical step. Either client or third party conventional bioreactors can be used or SimCell™ 0.2-1.0 mL MicroBioreactor Arrays can be used for rapid results from hundreds of experiments at a fraction of the cost of conventional bioreactors. Recommendations for appropriate cell characterization and screening for presence of any adventitious agents are also provided at this stage.

Optimal Process Selection - Is a batch, fed-batch, or perfusion the best production process selection? Factors such as eventual market demand, product concentration, volumetric productivity, media utilization efficiency, cell line stability, batch-to-batch consistency, regulatory burden, media cost, and skills of process operation personnel can ultimately dictate the choice of process. Process economics can have a large impact on making decisions at this stage and economic analysis scenarios can be prepared as part of any service. Either conventional bioreactors or SimCell MicroBioreactor Arrays can be used to assist with stage.

If a perfusion process is the answer, the best device can depend on many factors such as the cell line, target molecule, media constituents, process length, and bioreactor volume. Typical devices include the spin filter, continuous flow centrifuge, hollow fiber filters, ultrasonic settling device, and settling columns. Through appropriate documentation, release and in-process testing, the harvest from a perfusion process can be utilized to generate multiple lots. An appropriate scheme that meets the regulatory compliance demands will be offered to properly define how multiple “batches” can be derived from a single perfusion culture.

Bioreactor Process Optimization - What experimentation is required to optimize process development by minimizing costs and decreasing the project time line. Assist in identifying the key critical process parameters upfront. In particular, for a perfusion culture, media optimization at high cell densities requires an appropriate perfusion rate in order to sustain a robust culture with high viability without washing out the culture too fast and hence wasting precious cell culture media.

Process Scale-Up - Whether planning a new facility or going to a CMO, there are numerous factors to consider when scaling up a process. If operating a batch or fed-batch production process, is perfusion an option for optimization of your inoculum scale-up train to create positive process economics (minimize number of vessel and associated piping, instrumentation, and clean room space). A perfusion seed bioreactor can offer the advantage of a flexible inoculation schedule so that a greater time frame can be provided with excellent culture viabilities for a longer time window.

Process Validation - Identifying the key process parameters in a process and establishing in-process in-line as well as off-line monitoring and testing are important aspects of process validation. Recommendations for key parameters as well as monitoring, testing, and documentation of these items can be provided.

 

Please contact us at request@pendotech.com for more information.

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