OSMAN BAŞ

- Designed scalable processes adhering to ICH, EMEA, and FDA guidelines for quality and productivity, incorporating QbD principles.

- Established and managed a small-scale laboratory for upstream process development, including equipment purchasing and installation.

- Designed and conducted experiments for monoclonal antibody production using shake flasks and single-use stirred vessels ranging from 0.5L to 50L.

- Implemented fed-batch strategies to optimize cell density and product yield in bioreactors.

- Monitored cell culture parameters using advanced analytical tools such as YSI, Vi-cell XR, Osmometer, Nova BioProfile, HPLC, and mass spectrometry.

- Applied DOE (JMP, Design Expert) to systematically optimize media composition, feeding strategies, and process parameters.

- Developed scalable CHO (Chinese Hamster Ovary) clone selection protocols for high-producing cell lines, ensuring robustness and reproducibility.

- Conducted media optimization studies to enhance cell growth, viability, and product expression.

- Identified and optimized critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure process consistency and product quality.

- Developed and implemented glycan profiling methods to ensure the consistency and quality of glycosylated products.

- Supported downstream processing teams with upstream process knowledge and bioanalytical data to improve product yield and quality.

- **Process Validation:**

- Conducted process validation studies, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), to ensure compliance with regulatory standards.

- Implemented Process Analytical Technology (PAT) tools for real-time monitoring and control of critical process parameters.

- **Leadership and Training:**

- Provided comprehensive training and support to new team members, fostering a collaborative and innovative work environment.

**Upstream Process Development:**

- Extensive experience in mammalian cell bioreactor cultures, shake flasks, and single-use systems.

- Focused on optimizing critical process parameters including pH, dissolved oxygen, temperature, and agitation.

- Implemented real-time monitoring and control strategies to maintain optimal cell culture conditions.

- Collaborated with downstream teams on protein purification and bioanalytical testing to ensure product quality.

- Designed, optimized, and scaled up upstream processes for the production of therapeutic proteins and monoclonal antibodies.

- Conducted small-scale validation and process characterization studies to ensure process robustness and reproducibility.

- Utilized advanced bioprocess technologies such as high-throughput screening and automated sampling systems.

- Assisted downstream processing teams with data and samples for bioanalytical assays.

Upstream Process Design and Optimization

- Designed and optimized cell culture processes for protein production, including media development and bioreactor operations.

- Performed small-scale validation and process characterization studies to ensure consistency and compliance with regulatory standards.

- Assisted engineering teams in establishing and designing bioprocess facilities and labs, ensuring GMP compliance.

- Worked closely with downstream processing teams to ensure smooth transfer of upstream processes and supported bioanalytical testing.

Upstream Research and Development

- Conducted extensive literature reviews and research to select high-yield cell lines for biopharmaceutical production.

- Managed both prokaryotic and eukaryotic cell cultures for industrial and pharmaceutical protein production.

- Designed and optimized bioreactors for batch, fed-batch, and continuous processes, focusing on improving cell viability and productivity.

- Supported the purification team by providing high yields of inclusion bodies from small-scale bioreactors, facilitating downstream processing and bioanalytical evaluations.