Work Smarter, Not Harder: Accelerating Your Biologics Development and Commercialization

.Over the past decade, the biologics industry has seen double digit growth and an overall increase of market share. In fact, according to a 2020 market forecast report, the global biologics market is expected to be worth approximately $150 billion by 2026.

While this presents a great opportunity for biologics innovators, it also creates a fiercer market of competing small and emerging biotech companies who are all working their hardest to get that coveted, first-in-market position. Thankfully, regulatory authorities such as the US Food and Drug Administration (FDA) have recognized the uptick in innovative, specialty drugs, and have developed four distinct and successful approaches to making such drugs available as rapidly as possible. These approaches include:

• Accelerated Approval: The Accelerated Approval approach allows drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint, which enables the FDA to approve these drugs quicker.
• Breakthrough Therapy: This approach is designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapies.
• Fast Track: The Fast Track approach is a process to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
• Priority Review: A Priority Review designation means the FDA’s goal is to act on an application within six months—compared to 10 months under standard review. All orphan drugs are granted Priority Review.

With all being said, biotech innovators cannot rely solely on regulators to quickly get their biologics to market. There is a lot that can be done at the lab level to help accelerate a biologic’s journey from development to commercialization. It cannot be stressed enough—the name of the game in the ever-growing biologics market is speed, and for biologics innovators, speed can make or break your chances of getting to market first.

Let’s Talk About Technology

To help accelerate the development of your biologics, it’s important to have the right, innovative technology in place—particularly in the early phases. In fact, truly innovative technology can help speed up development timelines by six to sometimes eight weeks—if properly utilized. The right technology is out there, and it’s important to evaluate technology on how rapidly it can accelerate development:

• Berkeley Lights’ Beacon® Optofluidic System: This system utilizes light to move cells in and out of microfluidic chambers—allowing scientists the ability to process and analyze thousands of cells with more insights, at a much faster rate. To put things into perspective, the Beacon system allows you to analyze and process 7000 individual clones at once.
• Ambr15® Cell Culture: This high throughput, automated bioreactor system allows you to utilize 24 or 48 parallel cultivations at a microbioreactor scale—at 10 to 15 mL. This bioreactor system is highly flexible and is perfect for clone selection, media/feed development, early-stage process optimization, and screening under perfusion mimic conditions.
• Ambr250® High Throughput: The Ambr250® allows you to utilize 12 to 14 fully featured, single-use, mini bioreactors—at 100 to 250 mL—and is best suited for process development/optimization, scale-down studies, and cell culture and microbial fermentation.
• Single use technology: Single use technology (SUT) is great for rapid clinical material generation, as well as accelerating times to commercialization. With all being said, SUT can be costly for small and emerging biotech companies. If this is a concern, a larger CDMO who can still utilize SUT, but has robust processes in place to absorb the cost of goods, may be the best option for your company.

A Single Vendor Approach vs. A Multi-Vendor Approach

For many years, smaller operations have taken a multi-vendor approach when it comes to the development, manufacturing, and commercialization of their biologics. While this may sound good in theory—i.e., if we use individual specialists, we don’t have “all our eggs in one basket”—in practice, it may cause longer timelines, which can lessen your chances of getting a first-to-market position.

In order to be agile and quickly get your biologics to market, reducing the number of links in your chain from development to commercialization is paramount. Simply put, a chain with an increased number of links will increase the risk of delays.

More times than not, multiple vendors don’t have much of an incentive to work beyond what they’ve been contracted to do. Furthermore, many vendors have differing methodologies and definitions which cannot only slow your project down, but cause confusion for the next vendor. When your operation is responsible for handing off parts of your biologic’s journey, mistakes, oversights, and liabilities are bound to happen—which produces lengthy rework, slower timelines, and may increase cost.

To curb these risks, a more holistic, single vendor approach when it comes to outsourcing is becoming the wisest choice. This eliminates your need to coordinate and manage multiple vendors and will ease the overwhelming logistics of biologics development, manufacturing, and commercialization. In doing this, you will have more time and resources to do what your operation does best—discovering the next life-changing biologics innovation.

Finding an Adaptive CDMO Who Provides an Accelerated End-to-End Solution

As the biologics industry continues to pivot and adapt to the changes and challenges due to COVID-19, the savvy CDMO will still find ways to accelerate development. By effectively leveraging technology transfers and streamlining validation pathways, CDMOs can shave months off the development timeline of standard programs:

• Tech transfer: The savvy CDMO will bring forth standardized processes, streamlined protocols, and templated documentation to drive speed and efficiency.
• Process validation: CDMO industry leaders will have clearly defined policies, integrated process flows between late-stage technology transfer, and sound process validation.
• Process characterization: The right CDMO will prepare for and mitigate risk at every corner as well as provide a scientific approach to balance timelines and process understanding.

Lastly, if a CDMO claims they have an end-to-end solution, make sure they can back it up. Many vendors will promote such an offering, but unless they can provide tangible evidence that their internal programs can accelerate development timelines and a proven track record of quickly getting biologics to market, their claims may be more promotional than an actual reality.