March 5, 2024

Using AR/VR for Process Documentation and Verification in Pharma, Biotech, and Cell and Gene Therapy Manufacturing

Kevin Conard
Kevin Conard


There are numerous use cases for augmented reality/virtual reality (AR/VR) in the manufacturing spaces of the pharmaceutical, biotech, and cell and gene therapy industries, and some have started to gain traction. Pharma has begun to implement AR/VR technology in their manufacturing processes to improve efficiency and safety. For example,companies may use AR headsets to provide real-time guidance to workers during complex assembly processes or to overlay vital information onto equipment or packaging.


In the biotech industry, AR/VR is being utilized for various purposes such as virtual prototyping of equipment, training of personnel in sterile manufacturing environments, and visualizing complex biological processes. Biotech companies are also starting to use VR simulations to plan and optimize laboratory layouts or to simulate the behavior of biological molecules.


Cell and gene therapy companies often deal with intricate processes involving the manipulation and cultivation of living cells. AR/VR can assist in visualizing these processes in three dimensions, facilitating better understanding and optimization of production workflows. Additionally, VR can be used for training personnel in handling specialized equipment and following precise protocols. All of these uses show the power and promise of AR/VR technologies, but there is one key use case that is missing. Hands-free data entry and record keeping in a cleanroom environment.


The advent of stem cell culture opened the door for subsequent scientific discoveries, therapies, and industries that are only now beginning to reach the public, but in order to fully appreciate all of the benefits this technology has to offer, there must be a method to ease the cognitive load on the bench scientist, both in executing complex workflows and recording the material records, observations, and data. The ‘state of the art’ for cleanroom manufacturing is to have one technician witness and record the work performed by a second technician. This is both inefficient, unscalable, and a waste of resources. Why document 21st century science using 19th century means?


There are wearable AR/VR devices on the market that are compatible with the rigors of an aseptic environment, and when comparing the cost of the technology to the cost of an FTE that does not create value in the form of a saleable product, the choice is clear.


CultureTrax was built with the ultimate goal of combining the structured flexibility of the platform; the protocol template that informs decision point yet allows for the inherent variability of a biological system and standardized method for recording materials, observations, and data, with a hands-free AR/VR device for instruction and data entry.

There are obstacles to be overcome, implementing AR/VR technology in manufacturing environments can be costly, requiring investment in hardware, software development, and training.

Integrating AR/VR systems with existing manufacturing infrastructure and software can be complex. Ensuring compatibility and seamless interaction with other systems may require significant customization and technical expertise. There are also regulatory compliance issues to address including validation, data security, and sufficient training to ensure the validity of the system, but these obstacles are well characterized and well understood.


Regulatory agencies are increasingly moving towards digital systems as the norm, data security and integrity standards have tightened significantly,and the incoming workforce cohort is one of the most technologically savvy in history.


The benefits to be reaped from a hands-free AR/VR transition for biotech manufacturing are far reaching and systemic. The time is now.

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