3 Biopharmaceutical Manufacturing Trends to Watch in 2021

Since the advent of modern medicine, biopharmaceuticals have continued to revolutionize the treatment of both longstanding and emerging global illnesses.

In recent months, the COVID-19 pandemic has underlined the importance of the rapid development and distribution of biopharmaceutical products used to combat deadly diseases. In fact, many industry-leading researchers have hailed the COVID-19 vaccine as one of the most important medical breakthroughs in the last century.

Unfortunately, the threat of a global outbreak doesn’t end with COVID-19. Today, biopharmaceutical manufacturers must continually look for new opportunities to push the boundaries of science and technology in pursuit of life-saving products.

In this article, we discuss the top three biopharmaceutical manufacturing trends to watch this year. Use these insights to develop a proactive approach to product development, manufacturing, and distribution.

Biopharmaceutical Manufacturing Trends to Watch in 2021

As an industry-leading quality management software company, we’ve worked hand-in-hand with the world’s most promising biopharmaceutical manufacturers and medical device startups. During this time, we’ve gotten amazing insight into the latest biopharmaceutical manufacturing trends and developments.

In recent years, many biopharmaceutical startups and scale-ups have transitioned away from paper-based quality management systems to electronic quality management systems. It’s a relatively easy transition process—and one that delivers significant value to growth-oriented biopharmaceutical organizations.

 

However, quality isn’t the only investment area that life sciences companies should prioritize. Here is a complete list of the top biopharmaceutical manufacturing trends to keep tabs on in the coming months.

1. Bioprocessing

Are you prepared for the digital revolution?

Bioprocessing refers to manufacturers’ use of data and digital systems to improve product development, quality management, and more. Manufacturers will continue to look for new opportunities to digitize operations and replace labor-intensive processes with highly configurable, automated solutions. Over time, this will lead to improved product quality, safety, and compliance.

“Looking ahead, there is a clear industry movement to leave behind paper-based bioprocessing, data silos, manual process control, and equipment that cannot communicate with each other,” says Merrilee Whitney, Head of the BioContinuum platform at Merck.

To carve your own path toward the digital future, we recommend investing in a purpose-built quality management system. The right quality management system will provide immediate enhancements to your quality management and compliance programs. In fact, an investment in this area is the first step your organization should take to build and promote a quality-driven culture.

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2. Process Intensification

In recent months, we’ve seen an increased focus on process intensification. Rising industry demand has forced manufacturers to reevaluate the effectiveness of internal systems and workflows. From process simplification to material consolidation, process intensification improvements will continue to be a focal point for biopharmaceutical manufacturers in both the United States and abroad.

Here are a few process intensification success stories: 

These scientific breakthroughs were formulated on the basis that the status quo isn’t good enough. By identifying key gaps in biopharmaceutical manufacturing processes, these teams worked diligently to introduce simplicity and precision to product composition and development strategies.

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3. Supply Chain Management

In the coming months, biopharmaceutical manufacturers will look for opportunities to increase the effectiveness of their global supply chains. Unfortunately, COVID-19 placed considerable strain on the world’s reserve of biopharmaceutical products. As a result, teams worked collaboratively to fulfill the increased demand for healthcare products. As product demand increased, so did the vast network of suppliers and distributors.

Effective supply chain management requires manufacturers to monitor vendor relationships, product development resources, and manufacturing processes. When you consider the size and complexity of the global supply chain network, routine maintenance is critical. Before you begin, ask yourself the following questions:

  • What are the strategic goals and objectives of the business?
  • How does the business currently handle production and distribution?
  • Are there any gaps in the current supply chain framework?
  • When was the last time we performed a supply chain audit?

There are six types of supply chain management models, including continuous flow models, fast chain models, efficient supply chain models, custom-configured supply chain models, agile supply chain models, and flexible supply chain models. Finding the right framework for your business requires a careful analysis of business requirements, product development protocols, and distribution methods.

Recently, we’ve seen more companies use artificial intelligence to improve biopharmaceutical supply chains. This technology allows manufacturers to proactively monitor, identify, and mitigate risks. For example, artificial intelligence can be used to collect real-time data related to product forecasting and inventory. As a result, teams can optimize product development and manufacturing as supply/demand increases or decreases.

The Perfect Quality Assurance Plan for Biopharmaceutical Companies

The future of biopharmaceutical manufacturing continues to evolve at a rapid pace. To adapt to new and evolving manufacturing challenges, teams must invest in next-generation quality assurance practices and other innovations, including bioprocessing, process intensification, and supply chain management.

 

To help you confirm that your biopharmaceutical quality management practices are aligned with industry standards, we’ve created a simple resource: The Perfect Quality Assurance Plan for Pharmaceutical Startups.

Pairing your quality assurance plan with a modern quality management system will help your life sciences company achieve its strategic and financial objectives. Many quality teams rely on Qualio’s web-based quality management system to build and distribute life-saving products at scale. Over the years, we’ve successfully helped hundreds of quality teams migrate from paper-based systems to robust, enterprise-class software.

“The review and approval features are a big step up for our company. It’s also easy to create new versions of documents and do all the necessary linking between documents. Having those links is very helpful, much easier than digging through a file repository manually” — Matthew S., Senior Software Engineer.

Is Qualio right for your unique biopharmaceutical company?

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Kelly Stanton

Director of Quality