Why partner with a contract manufacturer to produce your assay?

 

Developing a new assay that will ultimately find commercial success is notoriously complex.

To that effect, managing your manufacturing processes in-house may initially appear to be the most streamlined and snag-free route to market. After all, what could benefit your production cycle more than having everything under one roof, ready for immediate analysis, testing and shipping?

In reality, overseeing every aspect of production in-house can place a strain on resources, create bottlenecks and delay commercialisation and revenue.

Partnering with a contract manufacturer and building a long-term relationship is often the key to success. Here’s why…

 

Specialised expertise

When formulating your assay, you may not have the expert knowledge in-house to lead the transition from assay development to manufacturing. Does your team have, for example, the intricate knowledge of stabilisation techniques and buffer reactions needed to make this process a success?

By partnering with a contract manufacturer who is armed with such experience, that transition can lean on years of highly technical expertise, which only continues to evolve and grow with each new project.

The more experience a contract manufacturer has, the quicker and smoother your route to market will be. Years of experience can equate to a reduction of months of trial and error and re-testing, with no surprise upheavals to your timescales, resource requirements or budget.

 

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Get to market faster, get a quicker return on investment

Bringing diagnostic assays to market is a notoriously slow process. But this doesn’t mean that timescales can’t be improved.

New formulations require expensive and time-consuming set-ups every single time. There are no shortcuts when creating an assay that is well developed and ready for market.

By choosing a contract manufacturer that also has development experience, you will benefit from the efficient manufacturing processes which can only come from a detailed understanding of the development process and the deployment of top-of-the-line equipment.

By being selective in your choice of partner, you will benefit from production cycles that will be far quicker than you would achieve in-house.  As a result, production time will be saved even from the very start, allowing for increased throughput at every stage.

Increased speed to market will allow you to commercialise and monetise your investment far earlier and achieve the desired ROI without tying up working capital.

Scientists working in lab on assay development

Increase flexibility while minimising risk

A key benefit of partnering with a contract manufacturer is their ability to scale.

Here’s the scenario: you start with a small run and suddenly find yourself needing to ramp up production. An experienced contract manufacturer will be able to accommodate this, quickly and easily. This means you can approach every step in your production cycle stage-by-stage, without needing to forecast your requirements prematurely.

The right contract manufacturer can take you to small, mid and large-scale output, with the capability to flex these requirements as you progress through your journey to market.

This freedom to adjust manufacturing requirements, even late into the production cycle, offers significant benefits to developers wishing to be flexible without suffering cumbersome financial and operational consequences.

This flexibility reduces the overall risk to your investment.

Any new product development will have a factor of risk. Your assay must be tested, assessed and managed throughout every stage of the manufacturing process. To do all of this in-house, you will need to contend with significant knowledge, time and resources barriers. It means a sizeable investment in all three upfront.

What happens if the product fails or is commercially unsuccessful, despite your best efforts to overcome these barriers and costs?

An expert contract manufacturer will be well-versed in risk management and will ensure that the best possible steps are taken to prevent a disastrous product launch. In addition, working with a contract manufacturer will allow you to benefit from smaller entry and exit costs – ideal for fast-paced markets where ROI must be achieved quickly, before the next development comes along.

Of course, flexibility isn’t just about managing risk. It’s about reacting to sudden opportunities and being fleet of foot enough to exit declining technologies and take advantage of new ones such as point of care testing.

This agility will empower you to respond to even the most volatile and unpredictable market forces, exigent demand and evolving biological threats.

 

Why Choose Biofortuna?

Expertise, risk mitigation, flexibility and accelerated speed to market are the four key benefits you will gain from partnering with a contract manufacturer. They will help you get a faster return on your R&D investment. You will benefit from all this if you partner with Biofortuna.

Our support is tailored around your exact requirements and defined by a problem-solving mentality. We listen to precisely what you need and find the solution to match.

We partner with some of the world’s most innovative assay developers, supporting them to take their assays from concept through to commercialisation by using specialist processes such as lyophilisation.

As global experts in freeze drying, we support a range of formats including bespoke lyophilised reagent beads. For many assays, lyophilised beads are the ideal solution, providing long-term stability at ambient temperatures, as well as dramatically reducing the risk of pipetting errors and contamination.

A combination of technical expertise, ISO 13485 and ISO 17025 accreditation, FDA registration and state-of-the-art facilities mean that product developers can rely on the highest scientific standards when bringing their product to market.

 

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