Recent years have seen innovation in many fields, such as software and computing, which has re-shaped and re-branded various process industries, including pharmaceuticals. These new technologies have enabled pharma industries to enhance product quality and reduce costs. It has also enabled pharma manufacturers to decrease time to market, which could previously take years.
For the pharmaceutical industry, these latest trends have changed the paradigm of every field – from drug discovery to drug manufacturing, procurement to warehousing and from drug manufacturing to marketing.
What are the latest trends in pharma industry that helps increasing the patient’s life?
Let’s look at some latest trends in pharmaceutical industry and how these have increased the efficiency of final product.
Increased use of CDMOs for manufacturing business
CDMO stands for Contract Development and Manufacturing Organization and provides pharma drug discovery, development, manufacturing and marketing facilities to pharma manufacturers with approved product lists. Still, they lack manufacturing facilities to manufacture their own. CDMOs have no approved product list and are not allowed to market and distribute any pharma product under their brand name.
CDMOs are full-scale manufacturing facilities on their own, having their quality department. They support pharma manufacturers that cannot produce their own facilities for any reason, such as cost issues, under-capacity resources or urgency in product demand.
Some benefits a CDMO offer for a particular pharma manufacturing organization include the following.
Helps to deal with pharmaceutical aging facilities
One of many essential components in pharmaceutical product manufacturing is the facility where a pharma process is carried out. There is a huge cost for constructing and maintaining these facilities. Additionally, some products also require dedicated manufacturing facilities, including the building.
However, as time passes, and if these facilities are not updated, they become outdated and are considered ageing facilities. In these facilities, pharma manufacturing operations are not allowed.
CDMOs are beneficial in these cases because they keep their manufacturing facilities updated due to their diverse nature of operations. So, if a pharma manufacturer decides to manufacture a new product that requires heavy investment for constructing facilities, CDMOs can be used to avoid heavy spending.
Effectively manage source
CDMO have expertise in sourcing. They can effectively source raw materials and other ingredients if one source becomes obsolete or dead.
They have flexible capacity
Since CDMOs often have diverse portfolios of pharma customers, they can usually manufacture any batch size of any type. This can be advantageous for pharma manufacturers over-burdened with their customer orders.
Strong supply chain foot print
CDMOs have excellent supply chain facilities that enable them to supply pharma products to every customer and diverse location services. They can also provide logistic support for sensitive products such as temperature sensitive. They are also able to provide on-time delivery and hard-to-reach areas.
Cloud based operations
Cloud computing is a new technology where computing services are available over the internet, irrespective of devices, associated hardware and location. The services can range from storage, monitoring, software and analytics. There is no need to configure each device or computer for accessing and utilizing these services. Normally, an internet device, network and access rights to these services are required to utilize these services.
The Pharma sector also benefits from cloud computing in its routine product manufacturing, ensuring quality in the final product, maintaining regulatory guidelines and other essential requirements.
Some benefits that cloud-based operations offer include the following.
Data Availability and Integrity: One of the critical requirements of pharma regulatory bodies is the security of pharma product data such as manufacturing procedures, batch history, equipment maintenance and quality results. These types of information must be readily available. It must also be secured and not be tampered with by any means. Cloud-based operations ensure data protection by restricting access to unauthorized persons and logging every change with personnel detail in existing data. This data is in electronic form, which means it can be readily available at any time electronically, of which integrity can be easily verified.
Inter-departmental collaboration: Cloud computing ensures effective communication and collaboration between different departments within a pharma organization. It helps to take timely decisions, effective planning and disaster management, contributing to the overall effectiveness of pharma production processes. For example, the production department can benefit from cloud computing by collaborating with the engineering department to plan maintenance activities, resulting in reduced equipment breakdown and increased production yield.
Cost-effective computing resources: In cloud computing, the user has to pay for the services that it is using rather investing in dedicated hardware and software resources. This option has several advantages, such as the service provider being responsible for software maintenance/upgrade, easy scale-up, and independence of the device to access cloud services.
Process Analytical Technology
Process Analytical Technology – PAT refers to collecting methodologies, tools, and technologies to monitor and control manufacturing processes. Critical process parameters are continuously monitored against pre-defined set points or key point indicators – KPIs, without stopping the process. One advantage of PAT is continuous monitoring, which enables production personnel to implement change if required. It provides an opportunity to implement quality attributes during production rather than in traditional testing, where the product is tested after manufacturing. It repeats the process to complete the quality requirements.
For the pharmaceutical industry, it provides benefits such as
Improving product quality during the production process, thereby preventing lag time to finish the production cycle, if quality parameters are missing
It reduces production cost and time, as testing is performed online without stopping the process – which contributes to a production delay.
PAT ensures product safety by implementing required quality parameters right from the beginning
PAT ensure regulatory compliance and reduces the risk of warning from regulatory bodies and the risk of shutting down manufacturing operations.
In PAT, monitoring is performed online at the equipment site. It prevents the need to stop the equipment, sample collection, preparation, performing testing, and then waiting for results. Eliminating these steps and processes significantly reduces the time for the final product manufacturing.
Pharma 4.0 is the pharmaceutical version of Indistry4.0, where the entire pharma production life cycle uses various digitalization techniques. Its main purpose is to benefit various stages of drug discovery, development, manufacturing, testing and marketing from the digitalization tools, to remove shortcomings in the existing manufacturing system.
Pharma 4.0 combines various independent technologies and tools, called enablers, that help implement digitalization in pharmaceutical manufacturing. Some of these enablers are described below.
Artificial Intelligence and Machine Learning
Artificial intelligence is the data-driven approach, which requires data to perceive the current situation and predict the future outcome. Commonly, AI is used in equipment maintenance, where it uses historical data for machine faults to predict maintenance before a major breakdown occurs. In pharma product research, AI uses a patient’s history and drug response to predict alternative medicine for better therapeutic effects.
Internet of Things – IoT
Internet of Things is a term used to refer to a network of industrial devices, such as sensors, drives and interfaces, capable of communicating and exchanging information without the need for any centralized control system or a main controller. The heart of IoT is software analytics that processes the collected data from sensors and devices using Artificial Intelligence and Machine Learning techniques. All equipment, instruments, sensors and associated components must have network operability and be able to exchange information.
Some applications of IOT that have benefited the pharma industry include the following.
Equipment Maintenance: IoT helps to effectively plan equipment maintenance, such as preventive and predictive maintenance. It helps keep equipment in running condition and free from breakdown, enabling pharma manufacturers to maintain market orders and prevent delays.
Inventory Planning: IoT helps to track the availability of inventory in the warehouse automatically without any human involvement. It allows for maintaining a database that automatically updates itself as the item moves into the warehouse, within the warehouse and outside of the warehouse. It allows us to keep track of every item in the warehouse and take helps to manage critical decisions such as procuring new items and production planning.
Clinical Trials: IoT can also be helpful in conducting and monitoring clinical trials. IoT-enabled devices can track the patient’s response to a particular drug. It can also help to monitor a patient’s drug intake routine. All the data collected is automatically transferred to centralized storage, where software analytics processes it according to predefined algorithms.
Logistics: IoT-enabled devices allow pharma manufacturers to monitor the logistics, especially for temperature-sensitive products that require a certain temperature until the patients consume them. In this case, the temperature is continuously monitored, and data is fed to centralized storage. Software analytics then processes the information and takes necessary action, such as alerting the pharma manufacturer and logistic provider in case the temperature reaches out of limits.
Augmented Reality is a new technology used in various industries worldwide. In it, the user can interact with virtual models of real-world objects and items with real-world scenarios. It allows its user to test various methods and see its result, which can become the basis of the advancement and upgradation of current systems and associated components.
In the pharma industry, AR can be utilized for
Training personnel before they are sent to deal with practical scenarios. It helps increase disaster management and conflict resolution without wasting practical resources.
Virtual testing products, such as in the quality department, instead of practically producing and then testing in the lab
Stability testing is the process of analysing and monitoring the active pharmaceutical ingredients/APIs or the final pharmaceutical products/FPPs stability over time to ensure that it stays safe and effective during its shelf life and under that labelled