Everything You Need to Know About Pharmaceutical Lab Innovation

Overview

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  • Source: Microbioz India
  • Date: 06 Dec,2022

India’s pharmaceuticals industry is a major player in the global pharmaceuticals market. India is ranked third in the world for production volume and 14th for value. India is the world’s largest supplier of generic medicines, with a share of 20% in global supply. It is also the top vaccine manufacturer worldwide. India is also home to the largest number of US FDA compliant Pharma plants. It has more than 3,000 pharmaceutical companies and a strong network with over 10,500 manufacturing facilities.

Some are calling innovative or collaborative partnerships in pharmaceuticals the “new norm.” However, authentic, independent or open source collaborations remain a rare feature of the life-sciences industry. There are many companies that have established in-house innovation labs. They believe these models are crucial to faster bringing new treatments to market. Collaborations can lead to novel treatments that no one company could create on its own.

The new technologies which characterize Industry–from connectivity and advanced analytics to robotics, automation–have potential to transform every aspect of pharma-manufacturing laboratories within the next five to 10 years. In real life, the first use cases have shown a 30-40% increase in productivity in labs that are already efficient and mature. A full range of improvements could result in a reduction of over 50 percent in quality-control costs. Automation and digitization will ensure higher quality and compliance, while reducing variability and manual errors. It will also allow for faster and more effective resolutions of problems.

Representative Picture

Although most of the latest technologies are available today, very few pharmaceutical companies have yet to see any real benefits. Quality leaders are often unable to articulate a business case for technological changes. This makes it difficult to convince senior management that lab automation or digitization can have significant impact. Companies rarely have a long-term strategy or blueprint for lab evolution. This can lead to costly investments that do not yield clear benefits. Many companies have taken steps to go paperless, such as simplifying paper records and digitizing laboratory testing records. These efforts are now being replaced by equipment connectivity, which allows direct transcription of thousands upon thousands of data points without the need for manual data transcription or reviews.

Data is essential for pharmaceutical laboratories. There are many data files that need to be stored, analyzed and shared. Data is vital for delivering the desired outcomes to insurance companies, governments and pharmaceutical companies. These laboratories also have to deal with complex laboratory processes. This includes fragmented data systems, validation of data from multiple sources, and regulatory requirements for data integrity. These are great opportunities for pharmaceutical labs to digitize their entire laboratory workflow to reduce costs, improve efficiency, and provide accurate and timely information.

Digital laboratory environments are able to give meaning and purpose to data. This allows for “digital moments”, where decisions can be made at the intersection of people, business systems, and connected devices. A digital laboratory, which includes analytics, laboratory equipment, consolidated platforms and consumables can communicate, analyze, and act on data in a highly efficient manner.

The Potentialities of a Digital Laboratory

1.While these questions sound lofty, they reveal the potential value of digital in laboratories.

2.What if the sample itself could “suggest” which method of testing is most compatible?

3.What if historical data could be used to predict preventative measures?

4.What if a rule-based engine could suggest improvements based upon an instrument’s performance?

5.What if systems could predict the availability of different instruments based upon their workflow?

Digital capabilities are able to create value in the five most important areas that lab metrics are measured.

Innovation – Smart Informatics systems can uncover new findings, highlight hidden information, and reveal new insights that were previously unanticipated or impossible.

Data Quality – Digital quality control/quality assurance (QA/QC), systems increase our confidence in data, interfaces and methods leading to a decrease in errors, product quality improvement, enhanced Electronic Batch Record (EBR), and improved compliance and regulatory adherence.

Data Security Many valuable research data are not protected by patents or are held by subcontractor clinical research organizations. This raises questions about third-party security and assurance.

Operational Efficiency- Digital Laboratory Information Management Systems, (LIMS), help to accelerate laboratory test milestones.

Profitability- Laboratories 4.0 (modeled on Industry 4.0) allows for more efficient data exchange and use of laboratory resources.

References:

1.https://www.paperlesslabacademy.com/2020/10/30/digital-pharmaceutical-laboratory/

2.Cabinet approves Production Linked Incentive Scheme for Pharmaceuticals, Press Information Bureau of India, 24 Feb 2021.

3.^ Jump up to:hasb “Indian Pharmaceuticals Industry Analysis: A Sectoral Presentation”. India Brand Equity Foundation. Retrieved May 27 2019.

4.^“India requires 75% local content in pharmaceuticals”. In Pharmatechnologist. January 2, 2019. Retrieved February 7 2019.

5.^Ahlawat & Associates (26 May 2022). “Development of Pharmaceutical Industry in India”. Lexology. Retrieved May 27 2022.

6.^“Pharmaceutical & Drug Manufacturers, Pharmaceutical, Formulations, Drugs, Medications”. pharmaceutical-drug-manufacturers.com.

7.https://www.ideas4allinnovation.com/innovators/pharmaceutical-innovation/

8.https://www.infosys.com/insights/industry-stories/digital-pharma-labs.html

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