At MyBiotech, we transform conventional or complex drug molecules into powerful, scalable nanomedicines.
We bridge the gap between early R&D and GMP nanomedicine manufacturing—ensuring your nanoformulation maintains quality, performance, and manufacturability at every stage.
At MyBiotech, we transform conventional or complex drug molecules into powerful, scalable nanomedicines.
MyBiotech has a proven international track record in scaling complex nanoparticle processes from laboratory scale to clinical manufacturing.
Our EU-based facilities deliver end-to-end GMP nanoparticle manufacturing solutions for nanomedicines and nanoparticle-based drug products.
MyBiotech operates an advanced aseptic manufacturing line designed for both liquid and lyophilized sterile drug product manufacturing of drug products.
Comprehensive Quality Control (QC) testing and stability services designed to ensure full understanding of the critical attributes and long-term product stability.
End-to-end regulatory support, including preparation of CMC sections for IND and IMPD filings, technical documentation, and regulatory strategy guidance for global submissions
Delivering integrated CMC services for nanomedicine from early development to GMP manufacturing including lyophilization services — with uncompromised quality and regulatory confidence.
MyBiotech integrates R&D, scale-up, analytical development, stability testing, and GMP manufacturing including aseptic fill-and-finish—all under one roof.
Our scale-up services enable a smooth transition from concept to clinic, including:
Designed for small and high-value batches, enabling efficient clinical development and scalable GMP production.
MyBiotech is a nanoparticle CDMO supporting end-to-end nanoparticle formulation development for nanomedicines—combining formulation expertise, process engineering, and GMP mindsets early in the project. We design and optimize formulations establish scalable manufacturing processes, and implement analytical methods.
We manufacture preclinical drug product batches to support toxicology, PK/PD, and efficacy studies. Using scalable processes and robust in-process controls, we deliver well-characterized nanoparticle formulations. Our team supports batch documentation, storage, and shipment, generating reliable data on the path forward.
We provide phase-appropriate QC testing to characterize and control nanoparticle drug products. Our testing portfolio supports release and stability programs, with clear specifications and trending. By focusing on critical quality attributes, we ensure consistency, comparability and regulatory readiness.
MyBiotech performs aseptic fill & finish for nanoparticle-based drug products, translating your formulation into a container-closure system that is ready for preclinical and clinical use. We support primary packaging selection and process definition. For formulations requiring improved long-term stability, we develop and execute lyophilization processes.
Two complementary nanoparticle engineering strategies enabling precise particle-size control, high API loading, and scalable nanomedicine manufacturing.
Highly controlled processes and defined critical parameters ensure excellent repeatability and consistent product quality across all manufacturing batches
Precise control of process parameters enables tunable particle sizes with narrow distributions and low polydispersity for consistent drug product performance
A nanomedicine CDMO supports the development and manufacturing of nanoparticle-based drug products—covering formulation and process development, scale-up, GMP manufacturing, aseptic fill & finish, QC, stability studies, and CMC documentation.
MyBiotech is a Germany based CDMO providing integrated services from early R&D through scale-up and tech transfer into GMP environments, including aseptic fill & finish (liquid and lyophilized), QC testing, stability programs, and regulatory CMC support for IND/IMPD filings.
Yes. We scale complex nanoparticle processes from laboratory scale to preclinical and clinical manufacturing volumes, with defined critical parameters, in-process controls, and structured process optimization.
Yes. We manufacture non-GMP preclinical and pilot batches to support IND/IMPD-enabling studies (e.g., toxicology, PK/PD, efficacy), using scalable processes and robust documentation.
Yes we are a Europe Nanomedicine CDMO. Our EU-based capabilities support GMP manufacturing of nanoparticle drug products, including GMP readiness activities, process optimization, and tech transfer for clinical supply.
Yes. We perform aseptic fill & finish for sterile liquid and lyophilized drug products, including primary packaging selection, container-closure strategy, process definition, and lyophilization development to support long-term stability.
Yes. We provide regulatory and CMC support, including preparation of CMC sections for IND/IMPD submissions, technical documentation, and guidance for meeting readiness (e.g., pre-IND).
Stay informed, connect with our experts, and discover how MyBiotech advances nanomedicine through trusted technologies and GMP manufacturing solutions.
