Process Characterization
Key Services to Support Your Product’s Commercialization
Identifying critical process parameters, process control strategy, and key quality attributes is crucial to improving the robustness of your drug product process as it progresses through the path to commercialization. To support the deepest understanding of your product’s development and processes, Cytovance Biologics provides a wealth of process characterization services.
Demonstrating Complete Process Understanding
Characterizing your process is an essential piece in modern drug development that ensures the manufacturing process delivers a quality product consistently so that the future patient is not at risk. Team Cytovance is skilled at designing studies to assess critical process parameters, operating set points, and process controls for both in-house developed and established processes. These studies can provide the basis for process improvement, process validation, and continuous process monitoring to ensure your drug product is consistently meeting required quality standards.
Quality by Design Approach
Team Cytovance always has our eye on your product’s long-term success and the key to that is quality. We build quality practices into the manufacturing process from the very start, checking in at key points, and not simply relying on QC testing the final product. With a strict adherence to Quality by Design (QbD) principles, we utilize a systematic approach that begins in the development phase with predefined objectives and an emphasis on product and process understanding and control. Our risk and knowledge based QbD strategies provide a reliable foundation for seamless integration into process validation and continuous product lifecycle management.
Incorporating Design of Experiment Methodologies
To design an efficient and effective process, Team Cytovance employs Design of Experiment (DOE) studies to develop sufficient process knowledge and understanding. By applying this model, we are able to reveal important relationships and multivariate interactions between process parameters and outputs. Using risk analysis tools, we can screen a multitude of variables to minimize experimentation and risk, while maximizing process characterization.
Integrated Portfolio of Services
Cytovance Biologics offers all of the key services and supporting process characterization studies necessary to keep your product development on track. From scale-down model qualification, unit operation studies, statistical modeling, and risk assessments to CQA and CPP identification, process control strategies, and scaled-up runs, our team has you covered.
Related Areas of Expertise
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Meet Team Cytovance in 2026!
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– BIO Investment and Growth Summit: March 2-3, Miami Beach, FL
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– OPCU Large Molecule: March 24, Virtual
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– World Vaccine Congress: March 30-April 2, Washington D.C. | Booth 536
– PEGS: May 11-15, Boston, MA -
– TIDES USA Oligonucleotide & Peptide Therapeutics: May 11-14, Boston, MA
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– BIO International Convention: June 22-25, San Diego, CA | Booth 4445
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– BioProcess International East: September 22-25, Boston, MA
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– CPHI Europe: October 6-8, Milan, Italy
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– CDMO Live Americas: October 19-21, Boston, MA
- – OPCU Large Molecule: October 27, Virtual