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BioReliance® End-to-End Solutions - Your CDMO Partner
CDMO

BioReliance® End-to-End Solutions
An Adaptive CDMO

We know that no two biologics development processes are the same and your needs can change in an instant or gradually over time.

That's why we offer adaptable contract development and manufacturing solutions for biotechs 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.


What is your biologics development challenge?
Our experts design custom solutions around you


Accelerate Identification
of High-Producing Cell Lines

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Increase the Titer of a
Difficult to Express Molecule

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A Fast-Track Automated
Mini-Pool Approach

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Reduce the Level of Host Cell
Proteins in the Bioreactor Harvest

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Scale Your Process
Directly from 3L to 2,000L

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Optimize the Formulation
of a Monoclonal Antibody

Learn more »

What do you need at this stage of your biologic's journey to market?

Speed in taking the next step to clinic » Expertise to plan for the long term »


You need to accelerate your journey to clinic?
Balancing risk and cost after getting funding for your drug development

Because every drug development process is different, we understand that you need an agile partner who intuitively understands your goals and not only mitigates risk, but also shares it with you.

We design process development strategies to deliver the optimal balance between speed to clinic and cost, without ever compromising on quality or patient safety.

Start your journey the right way for you.

Optimize your Biologic’s Analytical Program
for Greater Risk Reduction

Driven by the need for rapid advancement towards key milestones, what should an early-stage company think about when it comes to their analytical program?

What necessary information should a basic analytical program include? And what is the risk of short-cuts in analytical methods development?



Read our ebook »

Video: The main driver of regulations and risk assessment is to ensure patient safety.

Are you filing for IND?
Working with regulatory authorities

Because guaranteeing patient safety is the top priority throughout the development process, demonstrating this guarantee to regulatory authorities follows close behind.

Our wealth of experience working with regulatory authorities enables us to guide you through the IND filing process.

Contact our experts


How We Work With You

We accommodate at every step

  • Because we appreciate how critical it is to successfully reach each milestone in your journey to market, you can phase the spending and/or work to maximize efficiencies and minimize delays.
  • We work collaboratively and are able to seamlessly integrate with existing or new partners involved in the project.

We support along the journey of development and commercialization

  • We combine scientific knowledge, quality and compliance and operational excellence to build a strong relationship with you, and help you reach your goals at every stage.

We build strong working relationships around you

  • We adapt to your needs, anticipate your next steps, and let you own your overall process.
  • Our dedicated development experts work as an extension of your team, defining and managing each stage of your process with openness and transparency while keeping you deeply involved.

Our innovative, custom solutions help our clients accelerate their biologics development from DNA to clinic. Here's how we did it for them:


Accelerate delivery of high-producing cell lines

For clients with a very challenging timeline, our mini-pool approach as fast track allows us to use material from mini pools to start process development in parallel with cell line development.

Read case study »

Increase the titer of a difficult to express molecule

Our custom approach delivered the desired increase in productivity, without the need to explore different cell lines or change the molecular construct, and helped position our client to continue development of the molecule.

Read case study »

Key considerations for analytical development

Because analytical methods are so integral to your entire workflow, you should start early, at the time of upstream process development.

Read case study »

How do you get your upstream development right first time?

Learn about our plug & play upstream offer »

Brochures

Capabilities

You need to optimize for the long term?
From molecule to market, we're always thinking about your next step

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.


A Scale-up from 3L directly to 2,000L

Once a robust upstream process established, scalability is critical to support demand for drug substance during clinical development. We developed a strategy to enable a direct, efficient and robust tech transfer of a monoclonal antibody production process from a 3L bioreactor to 2000L without the need for any intermediate volumes.


Watch webinar now »

Are you planning for Tech Transfer?
Transferring your process at every step

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.

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.



How We Work With You

Choose the path that's right for you

  • We're part of a leading global Life Science Business, so you have access to a range of bioprocessing technologies and expertize to fit different budgets and routes to commercial success.

We turn global understanding into local solutions

  • We have a deep understanding of market-specific regulations around the world and how they are changing, allowing us to cater to your specific manufacturing requirements.

We enable regulatory excellence

  • We are trusted by leading regulatory bodies including the FDA and EMA.
  • Our understanding of compliance requirements and excellent documentation mean we are trusted by leading regulatory bodies, minimizing risk as you take your product to market.

Flexible options through single-use technology

  • We provide templated processes and mobility of equipment to create enhanced flexibility.
  • Through single-use systems you can achieve increased productivity, shortened timelines and an overall reduced cost of goods.

Our innovative, custom solutions help our clients find the right balance between speed and efficiency across all clinical phases and commercialization. Here's how we did it for them:


A direct scale-up from 3L to 2,000L

Our clients can significantly shorten their scale-up process thanks to our streamlined approach – accelerating the time to market and delivering a competitive advantage.

Read case study »

Optimize the formulation for a monoclonal antibody

For clients who are on an aggressive timeline and budget, we can deliver an optimized formulation in 3 months.

Read case study »

Reduce the host cell protein from bioreactor harvest

Our client had one month to reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

Read case study »

Key considerations for tech transfer

At some point, you will need to transfer a process either to another team for scale-up purposes or perhaps to another building, company or geography for manufacturing. Proactive planning for these events is essential.

Read best practices »




Adaptability is in Our DNA


Video: A partner for small biotech who want to outsource their molecule development from DNA to market.

We Bring a Wealth of Experience in Process Development

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 Experience


33+
Years in
process development
250+
Biologics
(Antibodies, hormones,
fc-fusions, recombinant proteins)
75+
GMP Drug
Substance Batches
Released since 2012

Track record

  • 80% fed batch, 20% perfusion
  • 100% scale-up success rate
  • 97% clinical GMP production success rate
  • Built our own single-use PD/GMP facility in < 1 year

Our Continuous Progress Drives Yours

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 Merck, allowing us to shape new technologies that can contribute to your success.


Video: Setting up a global network of biodevelopment centers.

A Global Network of Biodevelopment Centers

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.




About BioReliance® End-to-End Solutions

We are an adaptable CDMO partner for start-ups and small biotechs 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.



Download brochure »