We know that no two drug development processes are the same and your needs can change in an instant or gradually over time.
That's why we offer adaptable CDMO solutions for small biotechs and start-ups needing to develop and commercialize biologics. We do this by balancing speed, risk and cost through custom solutions, by leveraging our bioprocessing technologies and process development expertise, and by allowing our clients to transfer their process and knowledge to their end point at any step of their drug development. So rest assured that with more than 30 years' experience, more than 250 biomolecules and numerous GMP clinical Drug Substance batches, we can build strong working relationships around you.
When designing a strategy just for you, the following business considerations are essential:
Speed to clinic – heavy investments are being made in research and development without returns
Process efficiency – must proactively consider scale-up later down the line, not just speed early on
Filing strategy – to identify the right country to file in first and obtain access to the market quickly
When designing a strategy just for you, the following cell line considerations are essential:
Clone choice – lines that can produce the biologic at a high enough titer and quality are essential
Robustness studies – best practice to perform studies that replicate the conditions of scale-up
Genetic stability – protein production and quality should remain stable after >60 generations of cells
When designing a strategy just for you, the following process development considerations are essential:
Process efficiency – eliminating wasteful steps and optimizing multi-work areas and capacity utilization
Process viability – must reliably reproduce through scale-up and tech transfer to another operation
Financial viability – balancing productivity with cost for overall financial viability
When designing a strategy just for you, the following technology considerations are essential:
Flexibility can reduce cost of goods – single-use equipment enhances flexibility, templating and rapid suite configuration, and reduces cleaning costs
Scalability is key – when choosing technologies at the earliest stages, e.g. scaling a bioreactor used for mammalian cell culture from 3 L to 200 L to 2000 L
Evaluate for ease of use – solutions include pre-assembled sterile process flow paths; connectors that allow for aseptic connection, disconnection and re-connection
When designing a strategy just for you, the following regulatory considerations are essential:
Patient safety – as a priority, clinical development milestones must assess safety and product effectiveness
Product quality and process robustness – data collection and analysis should happen in parallel with process development
Dialog with regulatory authorities – knowing the countries where filing will happen should guide who inspects the manufacturing facility
Because every drug development process is different, we understand that you need a guiding partner who intuitively understands your goals and not only mitigates risk, but also shares it with you.
In an unpredictable, ever-changing environment, we can help you meet the high expectations of investors at a time when funding is often limited.
We design process development strategies to deliver the optimal balance between speed to clinic and cost, without ever compromising on quality or patient safety.
This flexible approach allows us to manage risk from pre-clinical development and through all clinical phases of development.
Start your journey the right way for you — reach out to us below.
Because guaranteeing patient safety is the top priority throughout the development process, demonstrating this guarantee to regulatory authorities follows close behind.
This means that cell line traceability is important from the very start of any process and throughout every phase, covering transfection and all components required during production.
Our wealth of experience working with regulatory authorities enables us to guide you through the IND filing process. This includes helping you detail the security of your master cell bank, your cell line manufacturing description and viral safety – ultimately proving that all your processes and control strategies are robust.
As you drive towards long-term commercial success, our adaptable approach offers the right combination of speed and efficiency through process scale-up.
Whether you have brought a product to market before or you are doing it for the first time, we will complement your experience and provide continued regulatory support to help you achieve long-term success.
As you move beyond the clinical trial phases, we will continue to find the balance between cost and speed so that you can get things right first time.
Reach your long-term goals the way you need to – reach out to us below.
We work with you to support reliable and reproducible tech transfer, no matter when or at what stage of the development process, ensuring the ability to move production between providers freely.
You can rely on our expertise and diligence to help you execute a successful transfer of product and process knowledge.
From defining critical quality attributes, to creating a detailed process description, and of course developing a successful transfer protocol, we can help you minimize time and cost spent during tech transfer while always staying in line with regulatory guidelines.
We're a small and flexible team, but we're also part of Merck KGaA, Darmstadt, Germany, one of the largest science and technology companies in the world. We bring a wealth of in-house expertise that helps biotech companies take their drug candidates from bench to bedside.
We provide bioprocessing solutions, combining technology and deep development expertise, giving our clients the agility to reach commercial success on their terms.
Our experts are always looking for innovative ways to optimize processes, ensuring you have an efficient and reliable process that balances productivity and cost.
We also have close working relationships with our colleagues at the Life Science Business within MilliporeSigma, allowing us to shape new technologies that can contribute to your success.
Our Martillac facility has been upgraded to a single-use platform, using our own products and technologies, and is now creating GMP batches for our clients.
In 2018, we added to our network by opening new biodevelopment centers in Boston, USA and Shanghai, China for process development and non-GMP production.
With all these facilities across the globe, we can support your vital work wherever it takes place.