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
The compounding of medicinal products begins with developing and identifying suitable substances, which are analyzed for their effects and side effects in preclinical trials.
Once an active ingredient candidate has been identified, it is combined with excipients in a specific dosage form, filled into suitable primary packaging 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 active ingredient preparation is initially tested in a smaller group and afterwards in several hundred to several thousand patients.
If sufficient valid data are available, market approval is usually granted. The medicinal product is now compounded commercially on a large scale and is continuously and systematically monitored after placing on the market.
Compounding of Investigational Medicinal Products for Application on Humans
According to Section 4 (14) of the German Medicinal Products Act (AMG), the compounding of medicinal products includes “the extraction, production, preparation, processing, transferring including filling, packaging, labelling and release”.
Especially the final steps of this process chain, such as filling and finishing, account for a significant part of the overall biopharmaceutical medicinal product compounding process. To focus on their core competencies, pharmaceutical companies often outsource these complex steps to contract manufacturing organizations (CMOs).
Medios is a CMO whose focus is on com-pounding of investigational medicinal products for application on humans:
- Manual, aseptic filling and finishing of liquid investigational medicinal products on a very small scale for batch sizes ranging from 1 to 3,000 units (fill & finish)
- Compounding of patient-specific investigational medicinal products
Fill & Finish
Manual, Aseptic Filling
With the growing use of individualized medicinal products and the resulting trend toward smaller batch sizes for small patient groups or individual patients, the demand for flexible filling and finishing options is increasing. This is particularly important in the field of clinical trials – an area in which the preparations are usually not yet approved and are therefore produced in lower volumes. Medios focuses on the compounding of investigational medicinal products and the manual, aseptic filling and finishing of injectable products on a very small scale for batch sizes ranging from 1 to 3,000 units.
The individual steps 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). Every 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 evidence of the compounded investigational medicinal products. The compounded 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 service offerings and product types in the field of fill & finish
Services
- Process development
- Compounding
- 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
- Cell and gene therapeutics (advanced therapy medicinal products, ATMPs)
Sterile & Non-sterile
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 trial centers at leading university hospitals.
Besides primary and secondary packaging of non-sterile solid dosage forms for the use as investigational medicinal products, we routinely compound sterile liquid investigational products in large and small volumes in customized dosages and formulations for individual study participants. In this case we use newly developed active ingredients or approved medicinal products whose efficacy is under test in a different indication with the aim of expanding their market authorization.
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 field of compounding
- 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 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
