Supporting the Future of mRNA Therapeutics

Wacker Biotech has opened a new state-of-the-art mRNA competence center to further upscale its support of innovative mRNA therapeutics. This new facility has several production lines which will have flexible control over production volume and process design.

Watch our new videos to get insights into the genesis of this new facility.

Trailer:

The mRNA field is poised for strong growth, expanding its applications from vaccines to personalized therapies. The challenges we face in broadening the range of applications include the need for flexible manufacturing processes. Wacker Biotech is setting up an mRNA competence center in Halle, Germany, with several production lines which will have flexible control over production volume and process design. Watch our trailer to get an insight into the genesis of this new facility and stay tuned for more episodes to come on this channel.

Episode 1: Building the Future of mRNA

Wacker Biotech is a full-service contract manufacturer.
We produce biopharmaceuticals, and this is subject to very specific and stringent requirements, which we are able to fulfil excellently thanks to our experience and the multi-faceted expertise of our employees.

Episode 2: Quality, Reliability and Scalability

As a contract manufacturer we offer our customers production capacity in a truly innovative field of pharmaceutical substances based on mRNA at very high levels.
With four independent production lines, we can produce a total of more than 200 million doses a year, if necessary. The plant is designed to turn out products on any required scale, from milligrams to kilograms.

Episode 3: Making Progress

This project is much more than just the building. It has to be equipped with specific production equipment, including clean rooms and fermentation tanks. These must be qualified and approved by the relevant regulatory authorities, meeting their strict quality and process standards. Join us on our journey through each step and through to the completion of this incredible project.

Episode 4: A New Level of Customer Service

The main demands made by our customers are flexibility, quality and, of course, speed. We serve as a workbench for small start-ups pursuing new, highly exploratory approaches. But we also flexibly function as a partner for large pharma companies ready to manufacture therapeutic products at scale. Our customers benefit from our deep expertise in the field of mRNA technology. This is based on decades of cooperation with universities and our R&D facility in Munich, as well as often very technology-oriented customer collaborations.

Episode 5: Teaming up for Success

Wacker Biotech has biopharma contract manufacturing sites all over the world – in Amsterdam, San Diego, Halle and Jena – each interlinked with the next regardless of location. This means we can offer customers the best possible solution – and a complete solution under one roof – when they come to us with a specific problem or requirement. The key to our success with completion of this cutting-edge facility is undoubtedly our international, multi-site approach. Bringing together a wide range of expertise from various international sites ultimately led to the success of the project.

Have a look at a series of interviews with our mRNA scientific experts.

A Dedication to R&D, Manufacturing and Client Success

mRNA is a completely new modality with no established textbook or manufacturing process. Dr. Sebastian Schuck shares how a strong focus on R&D in WACKER’s Munich headquarters combined with the personalized approach Wacker Biotech can offer as mid-sized CDMO have given the firm early mover advantage in the field of mRNA vaccines and therapeutics.

The Innovation Pipeline

Dr. Christian Hundshammer discusses how innovation is driving the advanced therapeutics field, from AI-based genetic sequence optimizations and mRNA formulations to targeted delivery for cell and gene therapies.
Wacker Biotech is a science-driven CDMO proud to work on the cutting edge of new innovations for human health.

The mRNA IP Landscape

Advanced therapeutics typically require a highly personalized approach tailored to a particular patient cohort. WACKER brings together the right facilities, scales and teams of experts to deliver these customized approaches.

And our platforms such as a proprietary strain for producing plasmid DNA make it easier to navigate a complex IP landscape.

Bridging R&D and GMP

mRNA is inherently an unstable molecule that requires robust process controls and analytics, especially when scaling up production.

Wacker Biotech scientists have many years of mRNA experience and are continually innovating alternative delivery platforms and new analytical methods for in-process checks.

Insights from Our Experts

“How Wacker Biotech is inspiring innovation in mRNA therapeutics”

“The processes for mRNA we have seen some years before will not be the processes which we will see in two years from now, and our facility is ready to already cope with these new approaches.”

Fierce Biotech interviewed Dr. Guido Seidel, our Managing Director, on how Wacker Biotech is inspiring innovation in mRNA therapeutics as a CDMO.

Watch the interview here (external link)

“In Halle, we have the capability to produce mRNA vaccines on a large scale within a short timeframe. Our high-end facility in Halle brings together our GMP competence for RNA product manufacturing and LNP formulation at scale,” said Dr. Sebastian Schuck, Senior Director, Client & Contract Management, Wacker Biotech.

Discover more about how Wacker Biotech will further upscale its support of innovative mRNA therapeutics in this new article by GEN.

Read the article (external link)

Engage the Experts for pDNA, mRNA, and LNP Solutions from Research to Commercialization

Wacker Biotech is your CDMO partner for the entire manufacturing chain of plasmid DNA (pDNA) and messenger RNA (mRNA) to lipid nanoparticle (LNP) formulations and Fill & Finish. We leverage our global team of development, process engineering, and manufacturing experts and a network of state-of-the-art facilities to accelerate our partners’ programs from research phase to the market.