We're all in
as your devoted CDMO and testing
partner, every step of the way.
CDMO and Testing Services
True Partnership Every Step of the Way
Bringing therapies to life takes more than science — it takes heart. It takes an ally fully invested in your success. That´s why we´re all in as your dedicated CDMO and testing partner, we stand with you at every step of your drug development journey.
With decades of proven expertise in contract development, manufacturing, and biosafety testing, we combine operational excellence with personal commitment to help you accelerate your milestones, minimize risk, and deliver your therapies to patients worldwide. We align with your goals and are committed to your success.
Whatever your innovation, whatever your challenge, we know that every discovery, every breakthrough, and every life improved requires a shared commitment to success. Together, we’re all in to accelerate progress and innovation.
Together We're All In
Experience the difference with our integrated expertise:
- Rooted in 35+ years of CDMO reliability.
- Backed by 75+ years of biosafety testing excellence.
- Partnership powered by a global team from preclinical to commercial.
- Personally engaged and committed to your therapeutic goals.
- Proven expertise in Small Molecule APIs & HPAPIs, ADC & Bioconjugation, mRNA & LNP, Viral Vectors, and Mammalian Biologics (testing services).
- Proud reputation of regulatory excellence and quality compliance.
"We’re all in for our clients and their patients. That means, we are all working together in lockstep with our clients across all the different functions to deliver better and faster treatments to patients in the safest and most effective way possible."
Benjamin Hein,
Head of Life Science Services
The Value We Provide
Known for our deep expertise & broad portfolio – with standard-setting innovations & template development to push the industry forward.
Flexibility through manufacturing and testing capacity – making significant investment in our capabilities and capacity to scale with the industry’s complex supply chain needs.
Decades of experience to inform and navigate clients’ pathways to approval. Our global regulatory know-how ensures high quality standards and regulatory compliance.
Focused Leadership Across Modalities
ADC & Bioconjugation
Antibody-drug conjugates (ADC) require a combination of precise design and specialized expertise — all delivered at speed. With 15+ years of contract development and manufacturing experience, we are recognized for leading expertise in the conjugation of drug linkers to monoclonal antibodies (mAbs) with facilities specialized for handling highly potent compounds.
mRNA Manufacturing & LNP Formulation
The mRNA landscape is rapidly changing, and clients need the latest novel technology and new therapeutic approaches to bring molecules to life. With the most comprehensive mRNA value chain in the market and integrated services, we successfully support clients from mRNA through lipids to LNP Formulation.
Small Molecule
Small in name, large in patient impact. We offer a true consultative partner approach to a broad spectrum of small molecule modalities. From APIs to HPAPIs, PEGs to ADC linker-payloads, targeted protein degradation to novel format conjugates, our decades of experience reduces complexity and minimizes risk in the race to commercialization.
Viral Vector
Our expertise with adeno-associated virus, lentivirus, adenovirus, and other vectors streamline the development and manufacturing of gene or cell therapy. Put trust in a partner with more than 25 years of relentless innovation of viral vector commercialization – setting the standard through the latest technologies and processes at speed. Whether clients are in pre-clinical phase or nearing commercialization, we have the resources, capabilities, and knowledge to advance current and future therapies.
The Global Footprint
We are a single organization with a global network to deliver contract development, manufacturing, and testing services across all stages of the molecule value chain.
Our 157,000 sq. ft, state-of-the-art viral and gene therapy manufacturing site houses upstream and downstream production suites, fill/finish, warehousing, QC, process, and analytical labs to support early phase to commercial manufacturing of suspension and adherent-based platforms.
Our site for LNP formulation and fill/finish services completes our mRNA value chain.
Our API manufacturing site SafeBridge® certified facility. One of the largest single-digit nanogram OEL CTDMO providers in the world.
Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Services include analytical development, cell banking, cell line characterization, viral clearance, drug substance and drug product release testing, as well as rapid methods such as Next Generation Sequencing (NGS) and the Blazar® platform for our integrated CTDMO.
Our ADC & Bioconjugation Center of Excellence. We have more than 35 years of experience as the leading expert in the conjugation of HPAPI to mAbs for ADC manufacturing.
Our API manufacturing site SafeBridge® certified facility.
Europe
Commercialization for large scale API production and portfolio lipids. Continued investment to expand our global network of API production facilities offers immediate development and manufacturing capacity.
Our biosafety testing service site houses our cell bank manufacturing, biorepository, cell line characterization, and drug substance and drug product release testing services.
Our mRNA manufacturing site for our integrated CDMO capabilities includes the development and manufacturing of custom mRNAs.
Development, manufacturing and launch site for APIs, functionalized polyethylene glycols (PEGs), and lipids.
Our site features viral clearance study suites. Our Provise™ Clearance Service deploys a team of highly trained & experienced process scientists and study directors on your behalf, to perform all your required process steps at our state-of-the-art Stirling facility.
Asia
Biosafety testing service site conducting cell line characterization, viral clearance, and drug substance and drug product release testing for our integrated CTDMO.
To continue reading please sign in or create an account.
Don't Have An Account?