Services provided to CDMO partners

In its capacity as a contract development and manufacturing organization (CDMO), Prothya Biosolutions provides Professional Services to numerous companies in the industry. We harness our knowledge, capacity, and flexibility for the production process of our partners, for example for the production of API material, drug substances, final formulated bulk, and labeled and unlabeled vials.

Our nimble infrastructure allows us to provide specialized services. Partners can place any part of their value chain with Prothya Biosolutions and trust that we will meet their needs.

Services provided to CDMO partners image

Services provided to CDMO partners content image

Adding value

We work with our partners to deliver knowledge-based solutions. In doing so, we always strive to improve the process and add value to the chain. For example, by achieving higher efficiency in terms of purity, delivery reliability or yield of medicinal products per liter of plasma.

Thanks to this solution-driven approach, Prothya Biosolutions has become the largest CDMO partner in the blood plasma industry.

Services

Product/process development

Develop processes, parameters and attributes (QbD methodology)
Assess viral safety
Develop formulations
Evaluate plasma product stability
Develop and pre-validate analytical method
Characterize plasma and plasma products
Industrialize process
Validate single use devices
Control process limits, stability and capability

Contract manufacturing

Plasma intermediates valuation for industrial manufacturing
Plasma intermediates valuation and handling
Offer and expand manufacturing capacity
Tailored production process
API, drug substance, drug (bulk and final) product manufacturing
Audit readiness – EMA, FDA and national authorities

Plasma operations

Assess and audit blood establishments (recovered and apheresis plasma)
Transport and storage of plasma
Prepare plasma for industrial manufacturing
Support national self-sufficiency plans
Framework tolling activity
Dedicated supplier and customer relations

Our partners trust in our:

Capacity
Flexibility
Expertise

For over a decade now, Biotest has had enormous trust in its partnership with Prothya Biosolutions. Requests or even short-term inquiries are never a problem for Prothya, and, moreover, they constantly further develop their services. Due to the contract manufacturing services provided by Prothya, Biotest is able to produce life-saving products for patients all over the world.

- Biotest AG