The team of healthcare experts and analysts at BIS Research, recently, concluded an extensive webinar on ‘Biomanufacturing 4.0 – A New Era in Cell and Gene Therapy Development’. The webinar was hosted by principal analyst, Akash Mhaskar and senior research associate, Stuti Kandpal. The guest on this webinar were Mr. Likhesh Sharma and Mr. Mario Novoa Belman.

The session was full of industry insights as well as deep marketing intelligence around the emerging biomanufacturing 4.0 ecosystem and how can it is expected to transform the overall healthcare industry in the coming years. Some very critical questions were raised during the session by the attendees, which were duly answered by the panel of speakers.

Here’s an excerpt from the QnA that took place during the webinar:

Ques 1: Could any AI program predict the cost-effectiveness of a new therapy (or device) in a particular country?

Ans:  Artificial intelligence (AI) has the potential to forecast the cost-effectiveness of novel therapies or devices, subject to certain parameters and the availability of a considerable amount of data. Nonetheless, the absence of sufficient data presently constitutes a constraint to the accuracy of AI-based predictions, though, in principle, it is possible.

Ques 2: Which companies are working on cell and gene therapy in India?

Ans: Currently, in India, the scenario is more toward stem cell development. There are a few companies that are working on developing cell and gene therapy, such as Immuneel Therapeutics and Stempeutics.

Ques 3: How would emerging regions such as APAC perform in the future in the cell and gene therapy biomanufacturing space?

Ans: Based on the current scenario, Asia-Pacific (APAC) is expected to be the fastest-growing region in the cell and gene therapy biomanufacturing market. China has the second-highest clinical trials in the pipeline creating a lucrative opportunity for the biomanufacturers in the country. Other than China, India and Japan are also quite active in this space and are expected to further fuel the growth of the APAC cell and gene therapy biomanufacturing market.

Ques 4: How do you think the changing landscape in CMOs and CROs would impact the biomanufacturing industry as a whole?

Ans: With the rising numbers of approved therapies and entities in the pipeline, there are ample opportunities for both contract manufacturing organizations (CMOs) and contract research organizations (CROs). For setting up biomanufacturing facilities for both research and commercialization of cell and gene therapies, CMOs and CROs present an attractive prospect for cell and gene therapy biomanufacturers. Hence, as more therapies get commercialized or enter into clinical trials in the future, it will drive the growth of CMOs and CROs, creating a surge in demand for the equipment, consumables, and software solutions required for the manufacture of cell and gene therapies.

Ques 5: How do you perceive the introduction of allogeneic cell therapies in the near future?

Ans: The introduction of allogeneic therapies is expected to have a significant impact on the cell and gene therapy landscape, which has largely relied on autologous approaches involving the manipulation and reintroduction of a patient's own cells and tissues. However, allogeneic therapies utilize donor cells or tissues that are either modified or matched to the recipient's immune system, offering a potentially more accessible and scalable solution.

Allogeneic therapies are expected to reduce manufacturing costs and production times and increase the potential for off-the-shelf availability, enabling wider distribution and quicker access to therapies. They also have the potential to improve patient outcomes by addressing the current limitations associated with autologous therapies, such as the need for extensive preparation time and limited cell availability in some cases.

Ques 6: Who are the main software vendors in the cell and gene therapy biomanufacturing ecosystem?

Ans: Many key players, such as Thermo Fisher Scientific, Inc., Cytiva, WellSky, and Vineti, offer software solutions for cell and gene therapy biomanufacturing.

Watch the complete video below: