Bringing a new biopharmaceutical product to market is one of the most complex undertakings in modern industry. It takes years of development, hundreds of millions of dollars of investment, myriad regulatory hurdles, and a manufacturing capability that most drug developers do not possess to take a new molecular entity discovered in the lab and make it a reality on the pharmacy counter. Enter the Contract Development and Manufacturing Organisation – or CDMO – whose ability to provide these vital services to the biopharma industry is increasingly invaluable.
CDMO has flourished in the last 20 years – and for good reason. As biopharma firms have become leaner and the science more complex, the benefits of outsourcing or specialising development and manufacturing to a partner in the CDMO space seem an easy decision. For start-up biotechs, as well as larger pharmaceutical companies, outsourcing to a first-rate CDMO can mean the difference between developing a drug that gets to its intended target and one that never makes it out of the lab.
What a CDMO Does
A CDMO’s service offerings are more than turning products out on a contract basis. A comprehensive CDMO is a partner with a pharmaceutical company throughout the entire drug development process – from the initial process development and formulation work, through clinical manufacturing, process scale-up support, regulatory submission support, and finally the full-scale commercialisation of the drug.
On the development front, the CDMO’s process development scientists collaborate with those of the sponsoring company to make sure a process developed in the lab can be scaled up to the manufacturing scale. This is difficult work. A method of synthesis that works in a laboratory flask isn’t necessarily suitable for scaling up to reactors, and a formulation that is stable on a small scale may not be the same on a larger scale. CDMOs can quickly apply their extensive knowledge of process chemistry and formulation development, built over hundreds of different drug development projects, to these problems, and it may take years for a company’s internal teams to solve this.
Time is a Competitive Advantage
Time is the most precious and most easily lost resource in drug development. Patents are expiring, competitors are forging ahead, and every month spent between a successful clinical trial and filing the data with regulators is a cost and an opportunity lost. CDMOs are inherently fast, and the capabilities they provide (access to existing facilities, staff, analytical methods, and validated equipment) eliminate otherwise essential delays.
If a biotech company is starting a new programme, it would build manufacturing capacity in-house, which means designing and building a facility or leasing space, installing and qualifying equipment, recruiting and training staff, and validating methods. This takes at least a few years and $US10 million before the first batch is manufactured. A CDMO allows this process to happen much, much faster, with access to established facilities. A three-year development process to first-in-human studies can be reduced to only 18 months by working with the right CDMO early on in the process.
Clearing the Regulatory Path
CDMOs can make a difference from the start in regulatory compliance, especially for smaller firms that may not have extensive in-house expertise. The guidance issued by organizations like the FDA (US Food and Drug Administration), EMA (European Medicines Agency), and the TGA (Therapeutic Goods Administration – Australia) is comprehensive, stringent, and ever-changing. Processes have to be validated, documents need to be kept, and manufacturing facilities need to be inspection-ready 24/7.
An experienced CDMO has been through this process many times. They know what inspectors expect to see, how to maintain a quality system that meets regulatory obligations, and how to maintain documentation that will stand up to regulatory scrutiny, and they know how to ensure that every batch that is manufactured meets regulatory expectations. This knowledge is a great asset to a sponsor company. It minimises the chances of frustrating holdups due to regulatory issues, and it gives managers confidence that the manufacturing aspects of their programme will be in safe hands.
Flexibility Across the Development Stages
Another benefit of using a CDMO is flexibility as the development of a product progresses. In clinical development, you will need small amounts of material manufactured with a high degree of certainty, but for commercial production, you will want continuous production of larger quantities. These are very different manufacturing activities, and a company seeking to establish both of these in-house is faced with the challenge of holding two very different sets of facilities.
A CDMO that covers all stages of the development process – which not only has dedicated clinical manufacturing suites but also high volume manufacturing capability – can take the development through to commercial with minimal disruption. There are always risks in technology transfer between companies, and limiting the number of transfers is a way to limit both risk and expense.
The Benefits of a Long-Running Partnership
The successful CDMO relationships are not one-offs. They grow into something more like a partnership, over several programmes and manufacturing runs. If a CDMO team knows about a sponsor company’s pipeline, what type of therapeutic disease it is developing, and its long-term commercial goals and Cell and Gene Therapy, they can make predictions, identify potential pitfalls, and bring experience to the table before an issue arises.
This also builds towards greater economies of scale. Routines for communication, quality control, and decision-making alleviate any hiccups. Product development teams that are familiar with each other across campaigns have clear expectations and can act accordingly.
Conclusion
The purpose of a Process Development Services in the biopharma industry is not to “make drugs”. It is to offer the capabilities, resources, regulatory expertise, and flexibility needed to take a drug development program efficiently from the lab bench to the clinic and from the clinic to the market at the pace demanded by today’s biopharma industry.
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