PROCESS AUTOMATION IN THE BIOTECHNOLOGY INDUSTRY.

In the context of ever-rising electricity costs, increased compensation requirements for qualified personnel, and the need to protect technological secrets, the development of novel types of drugs is no longer possible without automated production lines and high-tech machinery. It allows laboratory researchers to rapidly move from pilot production to a scalable industrial process. They can increase the production volume depending on the company's development stage and market demand. In addition, they can replicate complex biotechnology processes, reduce raw material costs, and perform tasks incapable of being done by humans.

The automation of the R&D lab involves transferring management and control functions from humans to machines.

AN OVERVIEW OF THE PRINCIPLES, TYPES, AND METHODS OF BIOTECHNOLOGICAL AUTOMATION.

Automated processes are governed by the following principles:

• All processes must be clearly defined and interconnected according to the principle of consistency. We achieve 99.9% automation once automated equipment is configured correctly according to standards, regulations, and guidelines.
• The principle of integration dictates that the automated process should fit harmoniously into other biotechnology operations.
• For the automated and independent operation execution to be valid, the biotechnological process should be visualized and executed directly by a computerized program, confirming the correctness of the implementation by autonomous systems.

?Although the principles listed above are fundamental, the level of automation can be refined and detailed according to the specific operations.

Equipment development and automation are very complex and time-consuming tasks; the approach to such work is phased:

1. Automating simple and often repeated daily tasks is defined and implemented: maintaining bioreactor parameters and cell expansion, gas control, mixing, liquid supply, etc...

2. Next, the MIRCOD BIOTECH team analyses and automates the laboratory's tactical tasks. In most cases, this is a complex distribution of functions and the integration of devices into automated facilities - point of care (POC).

3. In the final stages, strategic tasks are resolved through development plans, which facilitate automation for remote control of laboratories or biotechnological production. An example would be the collection and solution of analytical problems, forecasts, etc.

A biotechnological laboratory or research facility determines how automation will be implemented and to what degree the processes will be autonomous based on financial and operational conditions.

THE GOAL OF R&D LABORATORY AUTOMATION.

The goal is to improve production process quality, reduce costs, minimize the resources required to operate the facility, eliminate errors caused by human error, increase safety, and improve accuracy.

Based on its complexity, there are several types of automation of a biotechnological process that require robotics and autonomous tools:

• Automating individual tasks.
• Automating of several inter-related jobs/tasks.
• Combining a set of multiple functions into an automated stand-alone device.
• Creating a computerized perimeter with integrated systems.

Creating cell and gene therapies requires automating the bill of materials (BoM) of consumed reagents and their self-replenishment (ideally with automatic replenishment orders) and generating automatic reports based on historical data and predictions on future research costs. This potentially developed AI platform generates, systematizes, and visualizes all laboratory costs.

Moreover, a promising direction in biotechnological process development is the automation of financial requirements and logistics/coordination for the implemented processes with a complete record of the results and, as consequence, full automation of development control and subsequent scalable production.

Significant profits and efficiency in the biotechnology and pharmaceutical industries are achieved by reducing costs and improving data collection in these two areas.

?BENEFITS OF AUTOMATION

?By automating everyday routines in biotechnological processes, oncology and orphan diseases are treated at a faster pace. By eliminating the human factor, the number of common errors is reduced to nearly zero, making it possible to improve the quality and reproducibility of results in any other laboratory. As a result of the development of process automation in biotechnology, ideal conditions for storing and processing more data are achieved, unrivaled by manual methods. Automation allows you to perform multiple tasks in parallel, on a 24/7 basis without the loss in quality or accuracy of the tasks performed.