The Big Picture: Understanding the pharma industry landscape

The key challenges facing US pharma companies today

1. Quality control

Over the last few years, the US has witnessed a surge of recalls triggered by contaminated APIs, many of which were produced overseas.

This not only wiped out a significant supply of heart medications, but also brightened the spotlight on quality for all drug manufacturers and their suppliers.

In very recent news, manufacturing lapses at a contract manufacturing plant resulted in the contamination of up to 15 million vaccine doses. While this could be viewed as a quality control success story – the mistake was caught by the drugmaker’s QC process – it nonetheless brings more attention to the importance of quality in manufacturing and demonstrates that mistakes can happen on our own soil as well.

Going forward, the question will be how the FDA and drug manufacturers can get control of quality both at home and throughout a global supply chain.

2. Data integrity

In 2018, 57% of FDA warning letters were issued to pharma companies for failing to meet data integrity standards.

And the pandemic has made data transparency even more important. The rapid spread of such a deadly, contagious disease forced pharma to develop and deliver treatments at an accelerated pace. Because of this, the industry faced an even greater degree of scrutiny about its decision-making processes in regards to testing treatments and vaccines. Pharma had no choice but to support decisions with robust and trustworthy data.

3. Complexities associated with new biologics

As new biologic drugs race towards market, manufacturers are finding themselves having to fundamentally reassess traditional supply chains, technologies, and operational approaches.

These pipeline biologic hopefuls include drugs in new therapeutic areas, such as cell and gene therapy, that are igniting the industry on fire with their potential to treat the previously untreatable.

But the industry is still grappling with the challenges of obtaining raw materials, scale-up, highly complex and specific manufacturing processes, and more personalized patient populations.

What are the significant changes in manufacturing over the past decade

Improvement in pharma tends to happen incrementally and manufacturing advancements are no exception.

One manufacturing trend that grew the most in the past decade is single-use bioprocessing equipment. While it’s definitely not a new trend (single use systems have been present in manufacturing since the ‘80s), it wasn’t until the last decade that nearly all bioprocessing equipment became available in SUS format, and adoption surged.

According to BioPlan’s Annual Report, single-use or disposable bioprocessing equipment is now used for more than 85% of precommercial scale biopharma manufacturing, and is increasingly being adopted for commercial manufacturing.

Single-use systems, which are essentially plug-and-play, have changed the game for product changeover and set up of processing lines in manufacturing, eliminating weeks of cleaning/sterilization needed with reused stainless steel equipment.

Overall, they’ve been extremely successful in increasing flexibility and reducing production lead times, while lowering capital investment and energy requirements.

What changes does the future hold?

Technologies like blockchain and AI have promise in pharma manufacturing, but I think pharma is still years away from figuring out the best way to utilize them.

We continue to see the FDA pushing the use of ‘emerging’ and ‘advanced’ technologies but without a lot of real-world examples from pharma.

To the credit of equipment vendors, pharma equipment is becoming smarter and more connected. The technology is out there, but pharma needs to find a way to best utilize it in an extremely risk-averse environment.

But I think the biggest change you are going to see is in the type of drugs pharma is manufacturing, and this, in turn, will change how drugs are manufactured. With more cell and gene therapies expected to be approved as we move forward, this sector will continue to grow.

This means that scalability and production costs will be a big issue. Pharmaceutical manufacturers will need to develop strategies and implement technologies that will scale more quickly and drive down costs.

Although the US administration has now changed, drug pricing will remain in the spotlight, thus forcing manufacturers to make increasingly cost-conscious decisions, and these decisions will likely include upgrading equipment and technology.

Conclusion

The point Karen raises about scalability and production costs is an important one for the burgeoning cell and gene therapies sector.

Manufacturing in biopharma is inherently complex - a single batch might have as many as 1,000 operations, and processes do not follow a linear sequence - so it is essential that production teams are able to carefully control the entire process. They need to manage costs and mitigate risk by maximizing capacity within the plant and batch yield, while maintaining the validated process in order to scale up successfully.

The digitization of planning and scheduling is helping manufacturers to scale up sustainably - for instance, one North Carolina biopharma company now has capacity to increase batches by almost 28% on the current output after moving away from manual methods. No matter how experienced a planner is, there will always be a time lag in reporting and action if they rely on spreadsheets alone.

Digitization provides insights based on real-time production data, helping to improve resource planning, allowing tasks to be completed concurrently and ensuring there is no under-utilized capacity. By continually optimizing the plan, using an unlimited number of algorithms, planners are able to reduce batch footprint and scale up effectively in line with demand.