Lead and clone selection are some of the most critical and challenging steps in early biopharmaceutical development. The selected molecules and clones determine the product’s critical quality attributes (CQAs) such as glycosylation patterns, charge variants, and aggregation propensity. These attributes affect efficacy, safety, and immunogenicity, and are hard to change later without restarting development.

We offer full-service cell line development, characterization, and cell banking of mammalian and microbial cell lines within our network of experienced CDMOs/CROs.

Through Biofidus, a member of the Midas Group, we offer in-house analytical services tailored to support early-stage biopharmaceutical development. Our core expertise lies in the structural and functional analysis of biopharmaceutical products. With a comprehensive portfolio of advanced analytical methods and deep experience in characterizing biological molecules, we enable you to make confident, data-driven decisions - from clone and lead selection to developability assessment.

With Biofidus, you gain the clarity and insight needed to move forward with confidence.

Popular Analytical Service Packages:

• Initial Protein Characterization
• Lead Selection
• Clone Characterization
• Developability Assessment
• Comparability Studies
• Molecule Stability Profiling in serum, plasma, or whole blood 

Popular Analytical Methods for:

• Primary Structure
• Post Translational Modifications
• Charge Heterogeneity
• Glycosylation Analysis
• Size Heterogeneity / Aggregation
• Purity Assessments
• Higher Order Structure
• Surface Plasmon Resonance (SPR)
• Cell-Based Assays

This integrated approach enables us to support you through every stage of your project from preclinical development to commercialization.

We offer both ready-to-use and contract development and manufacturing services for oligonucleotides, peptides, and payload/linkers. This includes intermediates and starting materials such as unnatural amino acids and amidites.

Additionally, we provide substances essential for the design and development of advanced drug delivery systems.

Biological drug substance manufacturing is complex and highly regulated, requiring deep scientific expertise, a robust quality system, and tight control of the manufacturing process. Partnering with experienced CDMOs and CROs can be essential when navigating the technical and regulatory challenges of biopharmaceutical process development in alignment with international regulatory standards.

Our dedicated quality team provides end-to-end support for batch record review and EU QP release, ensuring full compliance with the applicable EU GMP guidelines. For drug substances manufactured outside the EU, we provide EU QP import and release services, enabling smooth and compliant market access. Our deep understanding of GMP requirements and regulatory expectations allows us to identify and resolve potential issues early, ensuring a seamless and efficient release process.

Unlocking Regulatory Success with Confidence: Analytical Comparability Studies for Biosimilars

In today’s evolving regulatory landscape, the comprehensive analytical comparability study is more than ever the basis of the stepwise comparability exercise required in a biosimilar development. Detailed analytical assessments of structural and functional attributes ensure that the biosimilar is highly similar to its reference product, with no clinically meaningful differences.

Through Biofidus, a member of the Midas Group, we offer integrated service packages using state-of-the-art analytical methods – from mass spectrometry to bioassays – to support your strategy for innovative or biosimilar developments.

Popular analytical service packages:

• Forced Degradation Studies and Stability Studies
• Comparability / Biosimilarity Studies
• Impurity Characterization
• Analytical support for Formulation Development
• Analytical Up- and Down-Stream Process Support
• Tox. Batch Characterization
• Spent Media Analysis (SMA)

Popular analytical methods for:

• Primary Structure
• Post Translational Modifications
• Charge Heterogeneity
• Glycosylation Analysis
• Size Heterogeneity / Aggregation
• Higher Order Structure
• Surface Plasmon Resonance (SPR)
• Cell-Based Assays

Sterile Drug Product Filling – Precision That Protects Your Innovation

Sterile filling of biopharmaceutical drug product is a critical and technically demanding step requiring compliance with GMP and Annex 1 standards. Accurate transfer of sterile formulations into final containers, such as vials, syringes, or autoinjectors, must be executed under strict aseptic conditions to safeguard product integrity and patient safety.

Committed to accelerate your drug development, we deliver tailored, science-driven solutions that align with global regulatory expectations and commercial realities. With deep expertise in biologics and a robust network of qualified C(D)MOs, our team provides end-to-end support from early formulation through to commercial manufacturing.

Our integrated services reduce complexity, mitigate risk, and ensure seamless execution of your developmental activities.

Unlocking Regulatory Success with Confidence: Analytical Comparability Studies for Biosimilars

In today’s evolving regulatory landscape, comprehensive analytical comparability studies are more than ever the basis of the stepwise comparability exercise required for biosimilar development. Detailed analytical assessments of structural and functional attributes ensure that the biosimilar is highly similar to its reference product, with no clinically meaningful differences.

Through Biofidus, a member of the Midas Group, we offer integrated service packages using state-of-the-art analytical methods - from mass spectrometry to bioassays - to support your strategy for innovative or biosimilar developments.

Popular Analytical Service Packages:

• Forced Degradation Studies and Stability Studies
• Comparability / Biosimilarity Studies
• Impurity Characterization
• Analytical Support for Formulation Development
• Analytical Up- and Down-Stream Process Support
• Tox. Batch Characterization
• Spent Media Analysis (SMA)

Popular analytical methods for:

• Primary Structure
• Post Translational Modifications
• Charge Heterogeneity
• Glycosylation Analysis
• Size Heterogeneity / Aggregation
• HCP Analysis
• Higher Order Structure
• Surface Plasmon Resonance (SPR)
• Cell-Based Assays

Driven by the trend for home care and patient centricity, Drug Delivery Devices are gaining importance. At the same time, rising demands for higher concentration, volume, and viscosity – alongside innovative formulations – require a new innovative generation of devices that can meet these challenges.

Whether for low-viscosity solutions or highly viscous biologics, selecting the right device early in development helps prevent issues like clogging or inconsistent flow.

With a flexible portfolio of delivery systems, we help you meet diverse therapeutic needs — efficiently and reliably.

Our support doesn’t stop at the device. We offer a fully integrated solution that guides you from early formulation testing through to market launch.

This includes drug product filling, device assembly, packaging, and terminal sterilization.

You’ll also benefit from tailored regulatory support for both medical devices and combination products.

Efficient execution of clinical trials is key to accelerating the development of biological and biosimilar products. Our Clinical Trial Services support early-phase development with a robust infrastructure designed to meet both regulatory and operational demands.

We ensure clinical materials are manufactured, packaged, and distributed in compliance with international standards, with small batch sizes including manual filling handled with precision and care. Each batch undergoes thorough review and Qualified Person (QP) release to ensure quality and compliance.

Our team manages reference product sourcing to support clinical comparability studies and provides analytical QC testing of IMP/IND materials to maintain quality assurance throughout the trial lifecycle.

As importer and exporter of record, we facilitate the global movement of clinical materials, ensuring regulatory alignment across borders. For Phase I studies, we also offer CRO services, delivering experienced operational oversight to support successful trial execution.

Bringing innovative biological and biosimilar products to market requires navigating a highly specialized, evolving regulatory landscape. Increased scrutiny of scientific rigor and global harmonization efforts introduces unique challenges for biopharmaceutical developers, contributing to high development costs. Successfully managing these complexities demands deep regulatory expertise and strategic foresight.

In this dynamic environment, our team provides strategic and operational support, tailored to your product’s lifecycle stage.

We help keep projects on track for regulatory success by developing customized regulatory strategies, refined and aligned through scientific advice procedures.
Our experts support in authoring and reviewing key dossier modules to ensure clarity, consistency, and alignment with regulatory expectations.

Our in-house capabilities in eCTD publishing and global submission management help streamline the regulatory process and reduce administrative complexity.

For companies entering the EU market, we provide the necessary pharmaceutical infrastructure to act as Marketing Authorisation Holder (MAH), enabling a seamless and compliant market entry. 

Strategic collaborations drive innovation and market expansion in today’s competitive biopharma landscape. Leveraging the global Midas network, our Licensing & Partnering services connect with trusted industry players across the EU, USA, China, Southeast Asia, LATAM, and MENA regions.

With strong relationships and deep market insight, our team facilitates global market access and identifies high-potential partners aligned with your strategy and product portfolio. Whether expanding your pipeline, entering new markets, or monetizing existing assets, we provide the insight, network, and experience to make it happen.

We support negotiation and deal structuring to ensure agreements reflect your commercial and strategic goals.

Commercial manufacturing of a biopharmaceutical product is more than just filling; it's about consistency, control, and compliance. As your trusted partner, we exclusively work with qualified and experienced CMOs to ensure every batch meets the highest quality and regulatory standards.

Our services extend beyond manufacturing. Every manufacturing batch record is thoroughly reviewed by our experienced team. Our dedicated Qualified Persons (QP) for biopharma ensure seamless EU release and import. We provide end-to-end support including quality oversight and coordination with local authorities to keep your product moving.

Building Quality from the Ground Up — Your Partner for GMP/GDP Licensing and QMS Implementation

A comprehensively designed Quality Management System incorporating Good Manufacturing Practice and Quality Risk Management is the foundation of compliant and sustainable pharmaceutical processes. Whether preparing for inspection, achieving GMP/GDP readiness, or implementing corrective actions, our experienced team ensures your system meets all relevant guidelines. We also offer access to qualified personnel, including QPs, to support your operations during peak demand, capacity constraints, or critical project phases.

Launching a pharmaceutical product requires more than regulatory approval – it demands a coordinated strategy aligning supply chain readiness, compliance, and market access. We help define and execute tailored launch strategies to ensure operational continuity and regulatory alignment across the EU.

Our services cover the full spectrum of launch activities, including the setup and management of end-to-end supply chains, artwork coordination, and serialization. We handle supplier contracts and pharmaceutical responsibilities with precision, ensuring that all stakeholders are aligned and compliant. With in-house Qualified Persons (QPs), we handle batch certification, EU importation, and QP release seamlessly.

As your partner, we also act as Marketing Authorization Holder (MAH), provide in-house Qualified Persons for Pharmacovigilance (QPPV), and deliver wholesale and distribution services across the EU. Whether entering a new market or scaling up for commercial supply, we ensure your launch is executed with confidence, compliance, and speed.

Midas provides comprehensive life cycle and supply chain management for commercial pharmaceutical products – from production to final delivery. Services include product change management, logistics coordination, and the handling of import and export release to ensure timely, compliant cross-border product movements.

Midas also offers pharmaceutical infrastructure and serves as the Marketing Authorization Holder (MAH), ensuring regulatory compliance and product oversight for our clients´ products. Our team manages critical pharmaceutical responsibilities, e.g. Qualified Person (QP) batch release, batch certification and maintenance of robust pharmacovigilance systems.

Midas operates a dedicated customer service center to support our clients’ wholesale and distribution activities across the EU. Our services include order fulfillment, distribution, handling of returns, complaints, and recalls. EU wholesale release is handled in-house, supported by streamlined warehouse and inventory systems to ensure product availability and integrity.

To support our partners and enhance operational efficiency, we offer a range of value-added services such as sales and inventory reporting, product relabeling and repacking to meet specific requirements, and production of doctor samples.