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Logbook:

August

During my first month at Lilly del Caribe, I participated in the New Employee Orientations. This initial phase allowed me to get insights in Eli Lilly’s purpose, principles, foundations and the company mission. Furthermore, the on-boarding experience highlighted the significance of these principles in every facet of the company's operations. Through a blend of presentations and interactive workshops, I developed a profound appreciation for how these ideals underpin the company’s dedication to patient safety and product quality.

Most of my first three weeks were spent completing an extensive set of new hire modules. These modules covered essential aspects of working in the biopharmaceutical industry. Each module underscored the importance of being thoroughly qualified before performing any task, regardless how simple it might seem. Topics learned ranged from regulatory compliance and good manufacturing practices (GMPs) to standard operating procedures (SOPs). Completing these modules not only enhanced my technical knowledge but also instilled a sense of accountability and precision in every decision taken.

During this period, I worked hand to hand with the Contamination Control Strategy (CCS) team. The CCS team focuses on two core areas:  development of strategies necessary to prevent raw materials, intermediates and product contamination and equipment cleaning. As part of my internship, I had the opportunity to learn and work in both CCS areas. 

September 

By mid-September, I was introduced to one of the key projects I managed during my time at Lilly. The intent of this project was to simplify an existing protocol related to cleaning and protein sampling activities during product/campaign changeovers. To assess this task, I spent considerable time familiarizing with the approved protocol, understanding its current framework, and pinpointing areas for simplification. This preparatory phase included thorough reviews of SOPs, participation in targeted training sessions like data integrity, and detailed equipment walkthroughs. These steps ensured I was well-prepared to tackle the project with both technical competence and contextual understanding.

Moreover, I gained a holistic perspective on the insulin manufacturing process. This process starts with a genetically modified Escherichia coli strain and progresses through multiple fermentation and purification steps that allow the recovery of the Active Pharmaceutical Ingredient (API). Understanding the manufacturing processes that occur within PR05 gave me a broader appreciation of the intricate and interconnected stages of insulin production. Getting acquainted with the process provided me with a better understanding of the importance of cross-functional collaboration, precision, and adherence to stringent quality standards.

October-November

During October and November, I became deeply involved in the daily activities of the Contamination Control Strategy (CCS) team. This period marked a significant shift from introductory training to active participation.  My role expanded as I took on two additional pivotal projects, each focusing on distinct yet interconnected aspects of the CCS team’s operations.The first of the two projects, aligned with the cleaning group, involved developing a cleaning study protocol. This protocol aimed to establish a correlation between protein content and the visually clean state within the isolation process tanks. The goal was to determine a baseline relationship between the measurable protein residue in a tank and its visually clean state— defined as having no visible evidence of product or cleaning agents. This project required meticulous drafting, data collection, and collaboration with various departments such as quality assurance, automation engineering and manufacturing operations to ensure the study adhered to regulatory standards and best practices. Ultimately, it aimed to drive continuous improvement in the fermentation building, aligning the facility with the Biologics License Application (BLA) requirements set by the Food & Drug Administration (FDA). This experience underscored the importance of precision and validation in meeting stringent regulatory expectations. The second project was associated with establishing the requirements to adapt a non-GMP facility to GMP. For this purpose, a protocol was developed to establish an operational baseline of total non-viable particles and bioburden content of a Biological Safety Hood. In this regard this equipment provides a space for open/exposed non-GMP activities allowing to maintain an axenic environment. The project highlighted the role of environmental monitoring in the manufacturing process as a measure of the effectiveness of the established contamination controls.  Among my responsibilities were drafting the process characterization study protocol, preparing documentation for operational verification, and contributing to discussions on improving biosafety measures.

Throughout this period, I balanced project-specific tasks with broader CCS team responsibilities, such as participating in cross-departmental meetings and staying updated on regulatory expectations. This dynamic environment allowed me to further refine my problem-solving, communication, and technical skills while gaining a comprehensive understanding of the interdependencies between cleaning and PR05 contamination control strategies. These months not only deepened my technical expertise but also reinforced my appreciation for the collaborative effort required to uphold quality and safety standards in the biopharmaceutical industry. Each project brought unique challenges and learning opportunities, solidifying my commitment to contributing meaningfully to Eli Lilly’s mission of improving lives through innovative medicine.

Glossary:

  1. CIP: clean in place; automatic cleaning action performed without moving the equipment from its place

  2. Manual Cleaning: cleaning action performed manually and removed from its place

  3. ​BSH: biosafety hood; type of biocontainment equipment used in biological laboratories to provide personnel, environmental and product safety

  4. ​FDA: food & drug administration; responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, etc.​​

  5. BLAs: Biologics License Applications. Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm that manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biologic product. If the information provided meets FDA requirements, the application is approved, and a license is issued allowing the firm to market the product. 

  6. SOP: Standard Operation Procedure. Step by step explanation on how to perform a given task.​

  7. API: active pharmaceutical ingredient

  8. ​GMP: good manufacturing practices; regulations enforced by the FDA to ensure that products are consistently produced and controlled according to quality standard

  9. Quality: conformance to requirements or specifications â€‹grounded in the efficacy and safety of the Active Pharmaceutical Ingredients (API), formulation, manufacturing, and supply chain functions

  10. Supply Chain: the sequence of processes involved in the production and distribution of a commodity

  11. Industry: economic activity concerned with the processing of raw materials and manufacture of goods in factories

  12. Company: A group or assembly

  13. CCS: contamination control strategy; group in charge of the development of control protocols, standards and controls for the prevention of contamination.

  14. Laser Particle Counter: particle counter capable of monitoring non-viable particulate​

  15. RODAC plates: replicate organism detection and counting bacterial culture plates

  16. ​Bioreactor: tank, referred to as main fermenters, in which biological reactions and processes are carried out, especially on an industrial scale.

  17. Insulin: a hormone which regulates the amount of glucose in the blood. The lack of insulin causes a form of diabetes.

  18. Approval Process: process for SOP and protocol approval requiring drafting, reviewing and approval from the main groups involved in the document, such as process engineering, automation engineering, and quality assurance.

  19. GMO: genetically modified organism; biological unit used in the industrial production of insulin

  20. ISO-5: a controlled environment that limits the number and size of airborne particles, allowing no more than 3,520 particles (0.5 micrometers or larger) per cubic meter​​​​​​​​​

  21. TSA: tryptic soy agar; bacterial culture growth media

Supplementary Images:

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BSH: biosafety hood; equipment used for the inoculation and transfer of genetically modified E. coli

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Laser Particle Counter: environmental monitoring tool used to measure non-viable particulate

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CIP Skid: automated equipment for the effective cleaning of product contact equipments

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RODAC plates: TSA plates used to measure bioburden content

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