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TechInvention Sets Benchmark for Automated and Digitalized Vaccine Manufacturing Processes

TechInvention Sets Benchmark for Automated and Digitalized Vaccine Manufacturing Processes

Syed Ahmed , CEO, TechInvention

2024-08-16

Q: How does TechInvention ensure the quality, efficacy, and safety of the vaccines produced at the facility?

Syed Ahmed: TechInvention is dedicated to helping clients maintain high standards through robust quality management systems (QMS). By focusing on strict adherence to these systems, TechInvention ensures that clients' operations align with stringent international guidelines. Supporting the formulation of Standard Operating Procedures (SOPs) is a key part of this, as SOPs help in consistently achieving compliance and maintaining quality across various processes.

This approach is crucial for vaccines manufacturing where efficacy, safety, quality and reliability are of paramount importance. 

Q: Can you discuss the role of automation and digitalization in the new vaccine manufacturing facility?

Syed Ahmed: Automation philosophy strengthened by digitalization enables a seamless co-ordination and integration of multiple functions including but not limited to Production (Upstream, Downstream, Equipment), Warehousing Building Management System (BMS), Environment Management System (EMS), Quality Assurance (QA) and Quality Control (QC). Digitalization facilitates integration of the physical manufacturing functions through a digital interface like access and monitoring of manufacturing processes through devices like mobile phones, tabs etc.

Together, automation and digitalization create a synergistic effect that not only streamlines operations but also ensures higher levels of compliance, quality, and operational efficiency.

Q: How does TechInvention ensure compliance with global standards and guidelines in vaccine manufacturing and what are the key challenges in setting up a cGMP-compliant vaccine manufacturing facility?

Syed Ahmed: TechInvention emphasises on the significance of adhering to International Organization for Standardization (ISO) standards and World Health Organization (WHO) guidelines for biologics manufacturing. Thus, TechInvention advises its clients on establishing procedures based on the above-mentioned guidelines.

Normally setting up and operating cGMP complaint facilities require high CAPEX and OPEX which becomes a challenge in Low- and Middle-Income Countries (LMIC) and Low-Income Countries (LIC) settings. Secondly getting or sourcing adequately skilled and qualified human resource remains a perennial issue in such settings. Besides the above, rickety legal and Intellectual Property (IP) framework discourages international research institutes, vaccines manufacturers and organizations venture into partnerships and associations for co-development and technology transfers.

Q: What are the future trends in vaccine manufacturing that TechInvention is preparing for?

Syed Ahmed: We have established vaccine platform technologies for recombinant protein, conjugate and are working towards OMV-based and mRNA vaccines.

TechInvention’s upcoming state of the art facility, Global Collaborative Center for Medical Countermeasures (GCMC) initiative will enable comprehensive biologics development from strain to supply under a single roof thus erasing the need for multiple partnerships.

Our focus includes developing vaccines for diseases endemic to low- and middle-income countries (LMICs) and fostering public-private partnerships to speed up vaccine development and distribution. We’re also committed to sustainable practices, including reducing waste and energy use, and implementing green technologies like solar panels and rainwater harvesting.

Ensuring equitable global vaccine access, especially in LMICs, is a priority.

TechInvention offers consulting services from project feasibility to commercialization, aiming to enhance vaccine development efficiency and global public health resilience.

Q: How does TechInvention address the challenges of cold chain management in vaccine distribution?

Syed Ahmed: Our team and logistics personnel are well-versed in best practices for maintaining cold chain integrity, complying with WHO guidelines (ANNEX 9, ANNEX 3 TRS NO 962, ANNEX 3, ANNEX 5, TRS NO 999). We collaborate with leading logistics providers specializing in cold chain management, ensuring vaccines are handled and transported under the strictest conditions from manufacturing facilities to the final point of administration.

In an advisory capacity we advocate establishing local manufacturing and distribution hubs in strategic regions, thereby reducing the distance vaccines need to travel, minimizing the risk of temperature excursions and ensuring faster delivery times.

Additionally, we are developing innovative technologies to create thermostable vaccines using excipients to reduce the cold chain burden.

Q: What are the long-term strategic goals for TechInvention in the pharmaceutical industry?

Syed Ahmed: TechInvention is committed to advancing vaccine technologies by continually developing and enhancing cutting-edge platforms, including recombinant protein, conjugate, OMV-based, and mRNA vaccines. These efforts aim to address both current and emerging infectious diseases.

We are actively consulting on various vaccine manufacturing projects worldwide, with the goal of establishing local manufacturing and distribution hubs in strategic regions. This ensures timely access to high-quality vaccines and pharmaceutical products, particularly in low- and middle-income countries (LMICs).

Promoting sustainable practices is a core objective. We guide our project partners in reducing waste, energy consumption, and environmental impact, creating eco-friendly production systems that contribute to global sustainability in the pharmaceutical industry.

Given the rise of zoonotic infections and the threat of future pandemics, we are investing heavily in R&D to discover and develop novel therapeutics and vaccines. Our focus is on addressing unmet medical needs and emerging health threats, leveraging advanced technologies and scientific expertise.

The state-of-the-art facility being constructed at a strategic location in Mumbai will serve as a one-stop solution for vaccines, biotherapeutics, and diagnostics in the arena of infectious diseases, aiming to combat the global burden and improve lives.

Articles about interviews | August - 16 - 2024

 

 

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