Over the last decade, the biologics industry has grown by double digits and increased its market share. Indeed, the global biologics market is expected to be worth around $150 billion by 2026, according to a 2020 market forecast report.
While this is a fantastic opportunity for biologics innovators, it also creates a more competitive market of competing small emerging biotech companies, all vying for that coveted first-to-market position. Fortunately, regulatory agencies such as the US Food and Drug Administration (FDA) have recognized the rise of innovative and specialty drugs.
They have developed four distinct and practical approaches to making these drugs available as soon as possible.
Among these approaches are:
1) Accelerated Approval:
Under the Accelerated Approval approach, drugs of severe conditions that meet an unmet medical need are approved based on a surrogate endpoint, allowing the FDA to approve these drugs more quickly.
2) Breakthrough Therapy:
This strategy is intended to expedite the development and review of drugs that can demonstrate significant improvement over existing therapies.
3) Fast Track:
The Fast Track approach is a method for facilitating the development and expediting the review of drugs to treat severe conditions and meet unmet medical needs.
4) Priority Review:
When an application is designated as Priority Review, the FDA's goal is to act on it within six months instead of ten months in a formal review. Priority review is given to all orphan drugs.
However, biotech innovators cannot rely solely on regulators to promptly bring their biologics to market. A lot can be done in the lab to help a biologic's journey from development to commercialization. It cannot be overstated: speed is the game's name in the ever-expanding biologics market, and for biologics innovators, speed can break or make your chances of being the first to market.
Let's talk about technology.
It is critical to have the right innovative technology, especially in the early stages, to help accelerate the development of your biologics. When used correctly, genuinely innovative technology can reduce development times by six to eight weeks.
The right technology exists, and it is critical to evaluate it in terms of how quickly it can accelerate development:
a) Berkeley Lights Beacon® Optofluidic System:
This system uses light to move cells into and out of microfluidic chambers, allowing scientists to process and analyze thousands of cells faster. The Beacon system can analyze and process 7000 individual clones to put things in context.
b) Cell Culture with Ambr15®:
This high-throughput automated bioreactor system can run 24 or 48 parallel cultures on a 10 to 15 mL microbioreactor scale. This bioreactor system is highly versatile, ideal for clone selection, media/food development, early-stage process optimization, and screening under perfusion mimic conditions.
c) Ambr250® with high throughput:
The Ambr250® has a capacity of 12-14 complete single-use mini-bioreactors, 100-250ml, and is ideal for process development/optimization, small-scale studies, cell culture, and microbial fermentation.
d) Technology for Single-Use:
Single-Use Technology (SUT) is ideal for generating clinical material quickly and reducing time to market. On the other hand, SUT can be prohibitively expensive for small, emerging biotech firms. A larger CDMO that can still use the SUT but has robust processes to reduce the cost of goods may be the ideal option for your business.
A single-vendor strategy versus a multi-vendor strategy
Small farms have long used a multi-vendor approach to developing, manufacturing, and organic marketing products.
To be agile and quickly bring your organic products to market, you must reduce the number of links in your chain, from development to marketing. Simply put, a chain with more links increases the likelihood of delays.
Most vendors don't have much incentive to go above and beyond what they've been hired to do. Furthermore, many vendors use different methodologies and definitions, which slows down your project and confuses the next vendor. When your operation is in charge of transferring portions of your organic product's journey, mistakes, oversights, and liabilities are unavoidable, resulting in lengthy rework, slower turnaround times, and potentially higher costs.
A more comprehensive, single-vendor approach to outsourcing becomes the better option to mitigate these risks. This eliminates the need for you to coordinate and manage multiple vendors, easing the burdensome logistics of developing, manufacturing, and marketing biologics.
As a result, you'll have more time and resources to focus on what your company does best: discovering the next game-changing organic innovation.
Find an adaptive CDMO that offers a quick end-to-end solution.
The savvy CDMO will always find ways to accelerate development as the biologics industry continues to pivot and adapt to changes and challenges brought on by COVID-19. CDMOs can shave months off the standard program development schedule by effectively leveraging technology transfers and streamlining validation pathways:
Technology Transfer:
To improve speed and efficiency, a savvy CDMO will bring standardized processes, streamlined protocols, and model documentation.
Process Validation:
Industry leaders of CDMO will have clearly defined policies integrating late-stage technology transfer and robust process validation.
Process Characterization:
The right CDMO will anticipate and mitigate risk at every turn and provide a science-based approach to balancing timelines and process comprehension.
Finally, if a CDMO claims to provide an end-to-end solution, ensure that they can back it up. Many vendors will promote such an offer, but their claims may be more promotional than factual unless they can provide hard evidence that their internal programs can shorten development times and have a track record of bringing biologics to market quickly.
