Flexible aseptic fill and finish for clinical trial materials, personalized medicines, and advanced therapeutic products
Aseptic fill and finish for nanoparticle-based drug products and advanced drug delivery systems
Delivering confidence in every vial through high-quality aseptic fill and finish manufacturing.
MyBiotech offers aseptically manufactured sterile drug products across a wide range of modalities, including small molecules, nanoparticle-based drug products, and biotechnology-derived formulations.
Our German manufacturing site provides a full suite of sterile product development and aseptic manufacturing.
We develop sterile drug products with scalability and GMP readiness in mind—combining formulation development, process development, selection of primary packaging, and analytical support into one integrated workflow. Our services also includes lyophilized nanoparticle formulation cycle development. During development, we define a robust manufacturing process, critical process parameters, hold times, and sterile filtration approaches. In parallel, we evaluate primary packaging and container-closure systems to ensure compatibility, stability, and a reliable fill and finish strategy.
We provide non-GMP preclinical sterile manufacturing to generate high-quality material for early development—focusing on pilot batches for stability studies, preclinical batches, and reference material. Using controlled, phase-appropriate sterile handling and defined workflows, we translate your formulation into reproducible batches with consistent critical quality attributes. For preclinical supply, we manufacture batches suitable for PK/PD, efficacy, and toxicology studies, including clear batch documentation, sampling plans, and storage/shipping concepts.
MyBiotech provide quality control testing with a strong focus on the physico-chemical characterisation of nanoformulations to support batch release and stability studies. Using advanced analytical methods, we generate robust, decision-ready data on critical quality attributes—ensuring consistent product performance and supporting comparability as your program progresses from development to GMP. We combine phase-appropriate method development and qualification with structured data evaluation and trending, helping you define meaningful specifications and a control strategy that is ready for regulatory documentation.
We provide aseptic fill and finish operations for sterile drug products, including nanoparticle formulations, small molecules and biologics. Our services cover the complete workflow—from sterile preparation and defined hold-time strategies to filling into the selected primary container, stoppering/capping, visual inspection, labeling, and the preparation of retains and stability samples. We also offer lyophilization support. This includes feasibility assessments, formulation and excipient screening for lyoprotection, cycle development, and execution of lyophilized runs, followed by appropriate reconstitution testing and stability monitoring.
Stay informed, connect with our experts, and discover how MyBiotech advances nanomedicine through trusted technologies and GMP manufacturing solutions.
