Bioprocessing

Upstream processing (USP) includes the early stages of bioprocessing, including choosing cells for application, cell line identification and verification, cell culture, media preparation, and cell separation. The goal of the USP is to develop reproducible cell characteristics that can be harvested for drug development while ensuring purity and quality at every step.

Due to the sensitive nature of cells, even the most minute modification could result in downstream variation and wasted spending. Therefore, USP steps must be followed with extreme caution and attention to detail, and labs must track all relevant data points for each cell line, including media preparation, observations, vendors, equipment, personnel, etc. In the case of unexpected variation, labs that keep sufficient records are more likely to pinpoint root causes and rectify the source of error quickly.

CellPort facilitates and tracks all upstream bioprocessing from cell development to cultivation. Auto-scheduling & reminders ensure that the right actions are taken at the right time, while digital protocols and data analysis help labs track and monitor cell behavior throughout the process. CellPort not only helps expedite regulatory audits, but also ensures the smooth transition to downstream processing (DSP) processes.

Downstream processing (DSP) comprises the latter stages of bioprocessing, from cell harvesting to product packaging & shipping and all the steps in between. The overall purpose of DSP is to transform cell harvests into their final product formulation, whether it's a cell therapy, in vitro membrane, pharmaceutical, or biotechnology product.

As various cell products vary in their size and nature, labs must take into account the different separation processes required for their recovery and purification. Once harvested, cells go through several processes to isolate, purify, and concentrate the product from the complex bulk matrix, which may include acids, debris, and contaminants, in order to be transformed into a suitable form for its intended use.

Throughout the DSP, CellPort helps manage the extraction and purification of raw materials like Active Pharmaceutical Ingredients (APIs), product packaging, and everything you need to produce a finished product and reduce lab-to-market time. CellPort also helps labs to introduce a centralized data structure, achieve regulatory compliance, and facilitate real-time decision-making in bioprocessing.