Below you will find an organizational chart of departments commonly encountered in biotech companies. The organization is such that it provides efficient use of resources and cross-functional support to achieve a common goal. Click HERE and HERE to read more on departmental organizations.

MSAT

This is a group of process engineers that provides support to the biomanufacturing operators. The process engineers are in charge of process optimization and troubleshooting and process budgeting for equipment and raw materials. This group also looks to adhere to health, environmental, and safety regulations for the manufacturing processes. This group also takes care of process validation of newly transferred processes designed in the process development labs.

Biomanufacturing

This is the group of operators that works directly in the manufacturing plant and cleanrooms, following Good Manufacturing Practices (GMP) guidelines to manufacture the product. The biomanufacturing process flow normally consists of Upstream Bioprocesses, Downstream Bioprocesses, and Fill/Finish processes.

Quality Assurance (QA)

This group makes sure that the biomanufacturing operators are always in compliance with GMP guidelines and critical process parameters (CPPs) for the manufacturing processes. The QA group also works with the Quality Control (QC) group to make sure the product meets criteria for lot release (critical quality attributes or CQAs). The main goal of the QA group is to always be aligned with federal regulatory agencies, such as the Food & Drug Administration (FDA Title 21 of the Code of Federal Regulations), EMA, USDA, EPA.

Business

On the manufacturing side, the business group takes care of selling the product, manages manufacturing costs, revenues, and profits from sales, and also develops relationships with customers and potential collaborative partners.

On the laboratory side, the business group does market research to evaluate and find market opportunities. This group also evaluates portfolios and pipelines of current commercial products and product candidates.

Operations

This group manages supply chains, organization, and logistics, of raw materials for manufacturing runs and finished products for sale.

Facilities

This group manages the IT infrastructure and also the necessary utilities for the manufacturing processes (i.e. steam, waste, purified water). The groups also takes care of installation qualification, operation qualification, and performance qualification of new equipment and repaired equipment.

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In the manufacturing of biopharmaceuticals, the manufacturing of a biological product can be “fully integrated” with laboratories or be outsourced to a CMO or CDMO.

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Technology Transfer

This group facilitates the approval and organization of the protocols that will specify all the criteria for the product (technology), delineating the critical quality attributes (CQAs).

Process Transfer

This group facilitates the organization and approval of the protocols for the manufacturing processes, delimiting the critical process parameters (CPPs).

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Product Development Labs

This group improves current commercial products to extend patent life, and also performs the “translational” aspect. The “translational” aspect involves the process of finding commercial value in recent discoveries. In biopharma, the translational process is called “translational medicine.”

Quality Control (QC) Labs

This group utilizes a variety of analytical techniques (click HERE and HERE to read more on these techniques) to test the robustness and reproducibility of the biomanufacturing process, by testing the product at various points in the manufacturing process (in-process samples vs finished product samples).

Research Labs

This group performs basic research, discovery and screening of potential product candidates, and identification of lead candidates, for the creation of a product pipeline to be able to sustain the company’s growth.

Regulatory Affairs, Legal Affairs, and IP

This group evaluates the safety and efficacy of lead product candidates (i.e. pre-clinical and clinical trials in biopharma) to ensure compliance with regulatory bodies (FDA, EMA, EPA, USDA) to prepare for commercial authorization. This group also navigates the legal landscape of intellectual property (IP) protection, patent law, and external collaboration agreements.

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In the biopharmaceutical industry, laboratory operations can be “fully integrated” with manufacturing, or can be outsourced to CRO, CDRO, or University Core Facility Services (you can click HERE and HERE for examples of these services).

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See the organizational chart below: