What is pharma manufacturing?

A roadmap to pharma manufacturing

Pharma manufacturing refers to the industrial-scale synthesis of pharmaceutical drugs. This is a process with many challenges and techniques that practitioners will need to be aware of to ensure that drug development is optimized. Doing so offers clear benefits for any pharma manufacturer, as optimized production will invariably have a positive impact on organizational profits. Numerous methods and tools can be applied to enhance manufacturing optimization efforts, including:

1. Digital Manufacturing
2. Flexible Manufacturing
3. Continuous Manufacturing

Let us look at each of these points in detail.

• Digital manufacturing

  The term digital manufacturing essentially encompasses the application of digital tools or techniques to optimize the manufacturing process. This could mean the application of data and analytics or leveraging advanced technologies such as artificial intelligence (AI).

  These digital tools have been pivotal for enhancing the manufacturing process to combat uncertainty during the intense disruption caused by the Covid-19 pandemic. The rise of these digital tools ushered in the era of Industry 4.0, the ongoing automation of traditional manufacturing, with a report by Pharma IQ noting that 94 percent of pharma manufacturing practitioners were able to continue operations as a result of Industry 4.0 solutions.

  Similarly, the same report identified Industry 4.0 solutions in pharma manufacturing produced savings of 20 percent while improving quality and making deliveries more reliable.

  How digital manufacturing strengthens pharma’s product quality and speed-to-market (Source: Pharma IQ)

  “The first thing pharma companies need to do to achieve digital transformation is understand where the gaps are and digitally connect the entire process. By finding opportunities in the face of uncertainty and translating industry challenges into solutions that permit continuous workflows, pharma companies will be able to respond to risk quickly and enhance enterprise performance.”

  Brian Curran
  Senior Vice President Customer Success for Manufacturing Excellence at MasterControl

• Flexible manufacturing

  Flexibility in the manufacturing process is key, particularly in response to sharp increases in demand, which is what the industry has seen with the global need for speedy production of the Covid-19 vaccine. As revealed in a report by Rockwell Automation, Critical considerations for deploying smart, fast and flexible life sciences facilities, flexible manufacturing could mean executing smaller batches, optimizing asset utilization or being first to a new market.

  Implementation of flexible manufacturing facilities is on the rise, with many pharma manufacturers realizing the benefit of flexible tools such as single-use reactor bags, smart totes and mobile processing equipment. This allows organizations to quickly pivot the setup of the manufacturing process to respond to demand increases or enforced shifts in manufacturing focus.

  A discussion with MSD and Dassault Systèmes on building flexible and agile manufacturing operations for affordable, accessible and safe healthcare (Source: Pharma IQ)

• Continuous manufacturing

  Continuous processing techniques and technologies are being favored in the pharma industry to improve workflow productivity. As opposed to traditionally manufacturing drugs in predetermined batches, for example, continuous processing setups create an ongoing production cycle with no hold times, which allows for superior development speeds and enhanced process safety.

  The improvements that continuous manufacturing offers includes reduced manufacturing costs, particularly in the long-term, shorter production times and reduced human error rates.

  To achieve continuous quality assurance and product consistency in pharma manufacturing, see also: A Roadmap from batch to continuous manufacturing

Where to look for pharma manufacturing solutions

• The application of AI

  Using AI to optimize the manufacturing process is an area of increasing focus in the pharma industry. Developing new pharmaceuticals is a challenging process, with less than 10 percent of clinical drug candidates reaching approval. The primary reasons for this are the complex nature of the science that underpins pharmaceutical development, increasingly strict regulations and the necessity of more precisely defined patient populations.

  AI can be applied to improve target validation and quality of candidates, optimize clinical trial design through biomarker-based screening and reduce costs through the use of in silico database-trained methods. Aside from this, AI also has the potential to offer a solution for the increasing global complexity in pharma manufacturing processes and allow business development and licensing teams to automate necessary but mundane, manual tasks and focus on high-value activities.

  “AI could help us to secure a better deal, deliver a more thoughtful transaction and work together better”

  Ian Greenberg
  Executive Director of Corporate and Business Development at GlaxoSmithKline

  To make smarter manufacturing decisions and stay ahead of the competition, see also: Why you need AI to manage increasing global complexity

• Data and analytics

  In order to reach a stage where the pharma manufacturing process can be considered digitally efficient, and is underpinned and optimized by digital manufacturing techniques and technologies, manufacturers must first seek to implement findable, accessible, interoperable and reusable data principles.

  With research from Pharma IQ revealing pharma practitioners believing data and analytics will have a greater impact on manufacturing than any other trend between 2020 and 2014, it is clear that manufacturers are ready to embrace the era of enhance digital practices.

  “Pioneering pharma companies are beginning to discover it is time for a new approach to data-driven transformation in order to achieve the digitalization of processes.”

  Dr. Haydn Boehm
  Head of Commercial Marketing, Connected Lab at Merck Group

• High-density cell banking

  High-density cell banking replaces conventional seed train processes in the amplification of cells from cell cultures, which can traditionally take weeks of processing and multiple transfer steps. High-density cell banking has been shown to increase the density in cell cultures from 10 million cells per mL up to 100 million cells per mL, greatly accelerating this process and allowing manufacturers to decrease the tie to production for drugs such as vaccines and therapeutics.

How to optimize manufacturing processes?

• Maximizing operational efficiency

  Pharma manufacturers are increasingly emphasizing the necessity of process efficiency and cost containment measures to meet demands for cheaper generics and enhanced production speed. As detailed in Pharma IQ’s report, A guide to maximizing operational efficiency in pharma manufacturing, there are a number of ways that manufacturers can achieve this, such as implementing effective change management or control strategies and applying digital solutions such as smart connected labs.

   “When dealing with change, make sure this change is understood by everyone. This is not only important for the development of your business but also in helping to improve your manufacturing processes to meet customer demand and deliver your drugs safely to market at a low cost.”

  David Caron
  Vice-President, Chemistry, Manufacturing and Controls at Ayala Pharmaceuticals

• Improving pharma water monitoring

  Enhancing the efficiency of production methods while still maintaining acceptable safety and quality standards is a considerable challenge. One area where this is apparent is the use of water in pharma manufacturing, which requires close monitoring for microbial and total organic carbon (TOC) contaminants. The necessity of this strict monitoring represents a significant drain on time and resources in the production cycle.

  There are however, technologies that manufacturers can leverage to minimize this drain. The application of increasingly efficient water monitoring solutions that allow real-time monitoring for TOC and compliance management. Organizations can also leverage established solutions and guides to ensure that pharma water is always compliant by, for example, monitoring water for injection in real-time and driving continuous water monitoring in the manufacturing process.

• Applying digital manufacturing solutions

  With the clear advantages that digital manufacturing solutions can offer, as discussed above, many organizations will be seeking to understand how to go about implementing them. This is no simple feat however, as the complex nature of these digital solutions and the pharma manufacturing process as a whole means that the implementation of any new technologies and practices must be carefully considered.

  “One of the greatest barriers of achieving digital transformation end-to-end in pharma is that the industry is so heavily regulated and most processes involve multiple validation systems. Launching products to market requires numerous, and often siloed internal departments, working together but each with very different agendas.”

  John Lawrence
  Vice President Global Consulting at SGK

  Pharma IQ partnered with SGK Health to produce The roadmap to achieving digital success in pharma, which breaks down the methods for understand how to overcome regulatory challenges in digital transformation and improve market agility, with tips and advice from leading pharma manufacturing practitioners.

The value and outcomes of optimized pharma manufacturing

• How a digital approach can transform the manufacturing process

  The fact that implementation of digital manufacturing tools and technologies is now a key priority for many manufacturers comes as no surprise when you consider the beneficial outcomes that can be attained. These benefits include the reduction of manufacturing costs, increased production times and enhancing the ease of maintaining regulatory compliance.

  “Smart manufacturing processes promise to increase efficiency and reduce uncertainty. The potential public health value [and thus regulatory value] of “smarter” and more advanced manufacturing is even greater in the context of the ongoing Covid-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures.”

  Stephen Hahn
  Former Commissioner of Food and Drugs, and Anand Shah, Deputy Commissioner for Medical and Scientific Affairs

• Improving manufacturing outcomes with flexible manufacturing

  The application of flexible manufacturing practices can help manufacturers attain significantly improved outcomes for the production process. These outcomes include 25 per cent greater yield through reduced cleaning times and better application of labor as a result of technologies that enhance productivity, such as single-use reactor bags. Aside from these, manufacturers can reduce inventory needs through data controlled processes and decrease building footprints by reducing the need for permanently installed equipment and infrastructure such as hard piping

The reality of pharma manufacturing optimization

• How Merck digitalized its manufacturing processes?

  In 2020, Merck took steps to optimize manufacturing and production processes by teaming up with Siemens. The digitalization of manufacturing processes has enabled automation of modular production and has resulted in more flexible and efficient production.

  Read on in this update from Pharma IQ.

  For more case study examples, dive into this panel session with Takeda, West Pharma and MasterControl. 

  Pharma Manufacturing Automation 2021: Adopting Technology in the Quest for Digital Transformation (Source: Pharma IQ)

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What are the top three tips for optimized pharma manufacturing?

1. Leverage digital manufacturing technologies to help alleviate the stress of ensuring regulatory compliance and free up staff for increased productivity.
   
2. Ensure manufacturing facilities are flexible and agile to enable quick shift sin production focus to meet changing demands.
   
3. Employ data and analytics to enable real-time monitoring of compliance and production cycles.

Where to learn more about pharma manufacturing

Articles

• Three biotech trends shaping pharma's digital economy - Discover three technology trends accelerating digital transformation in pharma
• The technologies biopharmaceutical manufacturing needs to deliver new product types - Billy Sisk, Life Sciences Industry Leader EMEA at Rockwell Automation discusses the increasing adoption of disruptive technology in the manufacturing process
• Medical devices: Rapidly adapting to meet demand in a crisis - Billy Sisk offers insight into how to start your digital transformation journey to meet market demands during Covid-19

Whitepapers

• Top five trends for remaining competitive in the manufacturing landscape - MasterControl’s top five industry trends reveal how manufacturers can remain competitive by identifying new ways to accommodate the needs of the healthcare market

Online events

• Pharma Contract Manufacturing Online 2020 - Increasing pressures on quality, cost and scalability, continues to determine which manufacturers the industry outsources to. Given these challenges,- we have designed a highly interactive digital program to provide the industry with an opportunity to learn from each other's experience and find solutions to their current challenges.
• Pharma IQ Live: Pharma Manufacturing Automation 2021 - As the use of the robotics in the pharmaceutical manufacturing industry increases rapidly, it is important to consider the benefits of the latest technologies for manufacturers. This event focuses on focused on how automation has been transforming the pharmaceutical industry.
• Pharma IQ Live: Continuous processing 2021 - Continuous processing offers substantial benefits over traditional batch processing methodologies. This event focuses on increase asset utilization and reducing process variability, among other topics.