Trends and best practices in manufacturing: what can pharma & biotech learn from other industries?

The need to digitize manufacturing industries stems from the growing push for interconnectivity between different devices within an existing internet infrastructure. The Industrial Internet of Things (IIoT) or digitization trend can be subdivided into various trends such as sensorization, predictive analytics, artificial intelligence (AI), and cloud computing.

These trends offer many advantages, including the automatic detection of issues led by auto triggers in case of any abnormality in the manufacturing facility. They also help transform manufacturing tasks like the visual inspection of equipment in a plant, including quality checks to meet regulatory guidelines. Secure data storage, aided by cloud-based servers, can manage a variety of operations, ranging from enterprise resource planning (ERP) and financial management to data analytics and workforce training. Finally, IIoT ensures proper integration of supply chains, which is one of the major requirements of the manufacturing industry.

The goal of these technologies is to help industrial manufacturers manage their businesses with better intelligence and to make the manufacturing units more productive, cost- and energy-efficient, safe and, most importantly, streamlined.

Digitization in pharma & biotech

In the pharma & biotech industry, digitization helps optimize maintenance operations, increase process stability, accelerate process development, improve process performance,capture data and trigger alerts, monitor the quality of the drug being manufactured, and improve the supply chain logistics of the drug delivery.

Pharma & biotech manufacturers are facing several challenges due to restraining factors like the high cost of upgrading legacy equipment, shortage of adequately skilled work force, and security risks posed by the connected networks. Advantages lie in ensuring enhanced product quality, improved process efficiencies, reduced cycle times, reduced scrap and rework, tracked products, adherence to regulatory guidelines and reduced downtime. With digitization, the challenges are expected to subside over the next 6 to 7 years.

Another trend in the pharma industry is the transition from paper batch records to electronic batch records. Paperless manufacturing is expected to provide meaningful business insights, error-free data processing, optimized inventory levels, and proper production planning for overall equipment effectiveness (OEE) with real-time access to patient and drug-related data.

To ensure innovation while adhering to a set of regulatory guidelines, continuous process verification is used to validate and assess data generated during product manufacturing. Real-time tracking of the drug during manufacturing ensures proper viability, especially in cell and gene therapies where cell activity is affected by factors such as temperature and light.

The digitization of the supply chain in pharma & biotech ensures drug security and cost reduction. With the involvement of multiple stakeholders, it is imperative that the therapies are located as close to the patients as possible. Analytics also play a major role in providing real-time insights and a single-dashboard view of data to enable easy assessment of all critical parameters, ranging from incoming raw materials to the outgoing finished product.

Digitization drives the pharma market in terms of the two most important requirements in the manufacturing industry:

• Real-time product monitoring: As per mandate by regulatory authorities, manufacturers are expected to carry out more systematic checks at every point to ensure that there are no deviations from the prescribed parameters. Using early prediction and fixing any error which could result in an inconvenient incident helps avoid downtime.
• Predictive maintenance of plant operations: With the help of predictive analytics and cognitive intelligence, the connected equipment can report its own status, suggest an expiry date, and predict an impending failure. As a result, connectivity between equipment, work force, and computers is ensured across different levels, benefiting the cell and gene therapy supply chain and logistics.

IIoT-based smart MES solutions in manufacturing

Manufacturing execution systems (MES) are the integrated software applications which provide companies with the means to plan and schedule, track, direct, and implement their operations. According to Frost& Sullivan’s analysis, the MES market for the pharmaceutical & life sciences industry will reach $721.7 million by 2022 with a CAGR of 10.1%. Relying on paper-based batch records can make the manufacturing process extremely lengthy. This paper system leads to incomplete entries or causes manual transcription errors in as many as 1 out of every 10 entries. It can take up to 16 hours to create a paper-based batch record, up to 8 hours to create a paper-based device history record, and up to 48 hours to review a batch. Moreover, more than 25% of historical records can have QA errors. In such a scenario, MES plays an important role in providing optimal operational flexibility with the help of electronic batch records.

Why we need MES for cell and gene therapy manufacturing

MES solutions are needed to help overcome the following problems faced by cell and gene therapy manufacturers:

• Human-error-prone manufacturing: MES supports real-time deviation management by means of continuous process review.
• Slow treatment of patients: MES reduces manufacturing time by automating manual workflows and eliminating paperwork.
• Lack of scalability: MES scales up processes by almost entirely eliminating paperwork, capturing manual entries in batch records, and reducing the number of manual entries by up to 80%.
• Absence of proper tracking and documentation: MES ensures chain of identity (COI) and chain of custody (COC) for each patient, which helps eliminate fake drugs from the supply chain. Using material tracking technology, it ensures correct material and treatment for each patient.
• Absence of a proper analytics dashboard: MES captures, analyzes, and provides insights in the form of dashboards. This is extremely useful for cell and gene therapies where the processes are evolving.

IIoT has become an integral part of manufacturing and should be adopted by the pharma & biotech industry. This involves making important decisions, such as phasing out legacy systems and transforming current business models. The positive impact of IIoT on pharmaceutical manufacturing is indisputable. Market participants that can gauge its potential gains and take steps toward its implementation will eventually reap its many benefits.