We Redefine
CRo Partnerships
About Biofidus
Biofidus AG is a leading (bio)analytical laboratory founded in 2015 by a team of experienced local scientists in Bielefeld, Germany. Responding to the growing demand for outsourced analytics in the pharmaceutical and biotech industries, Biofidus AG provides comprehensive bioanalytical services as a dynamic one-stop partner for new biological entities (NBEs) and biosimilars. Drawing on decades of combined expertise in analytical development and strong connections within the pharmaceutical sector, our founders created a company dedicated to scientific excellence, regulatory compliance, and reliable project delivery.
Since its inception, Biofidus AG has built a strong reputation for high-quality (bio)analytical solutions, driving continuous growth. Today, we are a strong and growing company with a dedicated team of around 35 experts, renowned for our bioanalytical excellence, flexibility, and entrepreneurial spirit.
As a member of the Midas Pharma Group, we are embedded in a global network of 366 specialists across 12 subsidiaries worldwide, expanding our capabilities and international reach to deliver even greater value to our partners.
End-to-end
Seamless Support -From Discovery to Commercialization
Affiliation with Midas Pharma
Being part of the Midas Pharma group gives our customers access to commercial‑stage capabilities, including a broad portfolio of GxP‑related services and regulatory expertise.
In biopharma, this translates into integrated, end‑to‑end support from early development through clinical and commercial stages. Services span the supply of starting materials and intermediates as well as comprehensive combination‑product solutions with an innovative device portfolio.
For clinical and commercial phases, Midas Pharma offers a well-established EU pharmaceutical infrastructure that covers EU import and QP batch release, supporting launch readiness through Marketing Authorization Holder (MAH) services, a full pharmacovigilance system with in-house EU-QPPV oversight, and EU wholesale distribution.
Early Stage R&D
In-house analytical services
Structural & functional characterization
- Lead screening
- Developability assessments
- Clone selection
- Comparability & biosimilarity studies
- Method qualification & validation
- Troubleshooting
- Extended workbench
Cell line development with experienced CDMOs/CROs
- Mammalian
- Microbial (Bacteria/Yeast)
Intermediates & Drug Delivery Systems
Starting Materials & Intermediates for biopharma,
ready to use and/or customized
- mRNA
- TIDES
- Payload / Linkers
Substances for drug delivery systems, ready to use and/or customized
- Lipids
- Polymers
Development and manufacturing
with qualified & experienced CDMOs
- Drug conjugates (DCs)
- Synthetic TIDES
- Dedicated process steps, e.g. coupling
- Scale-up and transfer
Drug Substance
Drug substance development and manufacturing
with qualified and experienced C(D)MOs
- Manufacturing process development
- Scale-up & transfers
- ICH stability for drug substance & intermediates
Quality control testing
- Batch release
- In process controls (IPCs)
- For EU import
Analytical testing
- Comparability & biosimilarity studies
- Stability studies
- Method qualification & validation
- Elemental impurities according to ICH Q3D
Sourcing & supply of reference products /
reference listed drugs
Manufacturing batch record review
QP release and related services
- Certification / EU import
Establishment of alternative supply chains,
taking into account territorial diversity and
security
Drug Product
Drug product development & manufacturing
with qualified & experienced C(D)MOs
- Formulation development
- Primary packaging selection
- Manufacturing process development
- Scale-up & transfers
- ICH stability studies
In-house analytical services by Biofidus
- Comparability & biosimilarity studies
- Stability studies
Sourcing & supply of reference product
Manufacturing batch record review
EU QP release and EU import
Quality control testing
Drug Delivery Devices
Gx Inbeneo® autoinjector – ideally suited for formulations from low to very high viscosities
Gx Inbeneo® platform simulator – supports your formulation testing
Qualified and experienced CMOs
- Drug Product (DP) filling
- Device assembly
- Labeling & packaging
- Terminal sterilization
Regulatory support for medical devices & combination products
Portfolio of medical devices
Clinical Trialss
Manufacturing and packaging of clinical material, including distribution to CROs
Batch record review and QP release of clinical material
Sourcing & supply of reference product
Analytical QC testing of IND/IMP
Importer & exporter of records
CRO services for phase I studies
Regulatory Affairs
Definition of regulatory strategies
Scientific advice procedures
- EMA
- National European authorities
- FDA
Regulatory support IND/IMPD
Modul 1 and 2 authoring support
Review and authoring support of CMC dossier sections
Dossier compilation and publishing (in-house e-CTD publishing)
Pre-submission and registration support
Submission management and communication with authorities
Pharmaceutical responsibility as marketing authorization holder (MAH)
Licensing/ Partnering
Out-licensing & In-licensing
- EU
- USA
- China / Southeast Asia
- LATAM
- MENA
Identification of strong licensing partners
Negotiation of licensing agreements
Exit strategies
Access to development projects in various stages
Commercial Manufacturing
Commercial manufacturing with qualified & experienced CMOs
Quality control testing
Ongoing annual stability studies for commercial product
Manufacturing batch record review
QP release and related services
GMP readiness
Setup of a GMP-compliant, customized QMS/PQS
Setup & management of end-to-end supply chains
Establishment of alternative supply chains, taking into account territorial diversity and security
Launch
Definition of launch strategies
Set-up & management of end-to-end supply chains
Serialization & artworks
Launch coordination
Contracts with suppliers
Handling of pharmaceutical responsibilities
- QP batch release / certification / EU importation (in-house QPs)
- Marketing authorization holder (MAH)
- Pharmacovigilance (in-house QPPV)
Commercialization
End-to-end supply chain management of commercial product, including logistics
Import & export release
Handling of pharmaceutical responsibilities
- QP batch release / certification /
EU importation (in-house QPs) - Marketing authorization holder (MAH)
- Pharmacovigilance (in-house QPPV)
Wholesale & distribution in EU
- Customer service center
- Order fulfillment and distribution
- Return / complaint / recall handling
- EU wholesale release (in-house wholesale responsible person)
- Warehouse and stock management
Value added services
- Sales and inventory reporting
- Relabeling and repacking
- Doctor samples
Why biofidus
We are a family driven company powered by a team of interdisciplinary scientists who redifines what a CRO partnership should look like.
Our holistic analytical platform is designed to address complex structural and functional characterization of NBEs and biosimilars, delivering precise, decision-ready insights.
From startups to global pharma, and from early R&D through scale-up and commercialization, we provide seamless, end-to-end support, pairing scientific rigor with hands-on work to reduce risk and move projects forward.
Biofidus is a bioanalytical laboratory based in Bielefeld, Germany. We provide analytical and bioanalytical services using spectroscopic, sequencing, cell-based, chromatographic and mass-spectrometric assays. We support projects involving protein biologics, biosimilars, and cell- and gene-therapy products.
We provide (bio)analytical services for the characterization of biologics. With a strong focus on data quality, regulatory expectations, and scientific rigor, we deliver reliable analytical reports, structural and functional characterization, and fit-for-purpose method development.
From routine high-throughput analyses to the development, qualification/validation, and transfer of client-specific assays, we help you answer complex analytical questions, de-risk development decisions, and accelerate progress from research to clinical development and regulatory submission.
Fast-track your development
We help define, prioritize, and close gaps to streamline and de-risk milestone delivery.
Our Team
Our interdisciplinary Biofidus team accelerates your development with fast, reliable, in-depth characterization of your pharmaceutical product. We help you focus on the questions that matter, delivering the data you need to reach milestones efficiently. We provide one-stop analytical support to solve even the toughest characterization challenges.