Clinical Trials with Medios:
First-Class Investigational Medicinal Products
Medios offers investigational medical specialists, sponsors, CROs, and pharmacies reliable Good Manufacturing Practice for clinical trials and a wide range of services.
Patient-Specific Therapies
As an expert for Specialty Pharma, Medios compounds ready-to-use therapies such as cytostatica, antibody therapies, and other infusions according to GMP standards.
From Active Ingredient to Medicinal Product
Manufacturing of medicinal products usually starts with development and identification of suitable substances, which are analyzed for effects and side effects in preclinical trials.
Once a drug candidate has been identified, it is combined with excipients to yield a specific formulation, filled into appropriate primary packaging materials and labeled to be tested for tolerability in a phase 1 clinical trial.
This is followed by phase 2 and 3 clinical trials, in which the selected drug product is initially tested in a smaller group and afterwards in several hundred to several thousand patients.
If sufficient valid data are available, marketing authorization is generally granted. The medicinal product is manufactured commercially on a large scale and is continuously and systematically monitored after market launch.
Manufacturing of Investigational Medicinal Products for Human Use
According to Section 4 (14) of the German Medicinal Products Act (AMG), manufacturing of medicinal products comprises “the extraction, production, preparation, processing, transferring including filling, packaging, labelling and release”.
The final activities of this process chain in particular, such as filling and finishing, account for a significant proportion of the entire manufacturing process of the medicinal product. To focus on their core competencies, pharmaceutical companies often outsource these complex activities to contract manufacturing organizations (CMOs).
Medios is a CMO focusing on clinical manufacturing of investigational medicinal products for human use:
- Manual, aseptic filling and finishing of liquid investigational medicinal products for small batches ranging from 1 to 3,000 units (fill & finish)
- Compounding of patient-specific investigational medicinal products
Fill & Finish Services
Manual, Aseptic Filling
With increasing use of individualized medicinal products and the resulting trend towards smaller batch sizes for minor patient groups or individual patients, the demand for flexible filling and finishing options is rising constantly. This is particularly important in the field of clinical trials – an area in which preparations are usually not yet approved and are therefore produced in smaller batches.
Medios is focused on the manufacture of investigational medicinal products and the manual, aseptic filling and finishing of injectables on a very small scale for batch sizes ranging from 1 to 3,000 units.
The individual processes of filling, labeling, visual inspection, packaging, and release are carried out in a clean, strictly controlled environment in accordance with the EU Guidelines for Good Manufacturing Practice (GMP). Each step is meticulously monitored and documented to ensure the highest possible product quality and safety.
We collaborate with accredited laboratories to provide qualitative, quantitative or microbiological proof of the manufactured investigational medicinal products. The manufactured investigational medicinal products are stored in accordance with GMP guidelines, at room temperature down to -80°C.
For shipping, we rely on nationally and internationally operating logistics companies whose portfolio includes temperature-controlled transport at room temperature down to -80°C.
Our services and product types in the fill & finish business
Services
- Process development
- Manufacturing
- Formulation
- Manual, aseptic filling
- Labeling
- Visual inspection
- Finishing & packaging
- Release
- Analytics
- Storage
- Logistics
Product types
- Cytostatics
- Small molecules
- Biologicals
- Nucleic acids (e.g. DNA, RNA)
- Peptides
Sterile & Non-sterile Compounding
Compounding of Patient-Specific Investigational Medicinal Products
Our years of experience in compounding patient-specific investigational medicinal products are frequently used by sponsors, clinical research organizations (CROs), pharmacies, and clinical trial centers at leading university hospitals. In addition to primary and secondary packaging of non-sterile solid dosage forms for use as clinical investigational medicinal products, we routinely compound sterile liquid investigational products in large and small volumes in customized dosages and formulations for individual study participants. This involves the use of newly developed active ingredients or already approved medicinal products whose efficacy is to be tested in a different indication with the aim of expanding their market approval.
The Medios network in Germany encompasses six GMP-certified manufacturing sites for investigational medicinal products in accordance with Section 13 of the German Medicinal Products Act (AMG).
Our services in the compounding business
- Compounding of sterile liquid preparations in large and small volumes
- Primary and secondary packaging of non-sterile solid dosage forms
- Compounding of active ingredients, placebo, and comparator products
- Study-compliant labeling, blinding, and randomization
- Procurement of active ingredients
- Temperature-controlled storage and logistics
- Regional supply
- National and international delivery to clinical trial centers
- Flexible compounding six days a week
Do you have any questions about our range of products and services? Would you like to find out how you can partner with Medios?
Get in touch.
We look forward to hearing from you!
Dr. Andreas Schmiede
Management | Vice President Advanced Therapies
