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Drug development capabilities

With more than 20 years’ experience in antibody drug discovery and development, as a partner MorphoSys can bring value to any biopharmaceutical program regardless of the development stage it is at.

Disease biology
and target validation

Discovering and validating novel target molecules and uncovering unique epitopes that define their role in a disease are key challenges faced by our industry. A deep understanding of the disease biology is a prerequisite for fulfilling this task successfully. MorphoSys has been active in oncology, both hematological malignancies and solid tumors, as well as in inflammatory and autoimmune diseases for several years. Taking into account the numerous partnered programs, MorphoSys has had exposure to an even broader spectrum of indications..

Technologies

Smarter tools provide faster, more flexible and, ultimately, better-quality access to drug candidates. With its core platform technologies HuCAL, Ylanthia and Slonomics, MorphoSys has delivered the gold standard of antibody generation and optimization in the industry. A set of auxiliary technology modules has been established to exploit the full potential of these core systems. Novel technology platforms are in development including a therapeutic peptide library based on lanthipeptides.

Drug discovery
and optimization

MorphoSys’s scientists are proven antibody experts. Our core capabilities, however, can be applied to a broad range of molecules and drug classes. In its partnered discovery alliances, MorphoSys has worked on more than 100 targets. It is noteworthy that MorphoSys’s current success rate from target to qualified antibody candidates is >95%. More than one in five of the programs we start progresses from antibody generation to the clinic.

Drug profiling and
assay development

The ability to design, construct and run assays that are specific, sensitive and robust is crucial in biomedical research. Assays play a crucial role in steering a drug discovery project to a successful outcome. MorphoSys has profound and well-established in vitro assay expertise for antibody profiling. This strongly contributes to the identification of the ideal therapeutic lead candidates with desired target specificity, functionality and optimal biophysical properties. The employment of state-of-the-art technologies together with MorphoSys’s constant endeavor to develop and integrate novel applications and in vitro assay systems minimizes the risk of drug failure at later stages in drug development.

Binding and interaction assays
  • YScreenTM automated picking & ELISA-based screening
  • 3P: Antibody specificity analysis
  • Ligand-receptor interaction
  • Analytical SEC: Dimer/complex formation
Functional assays
  • Meso Scale Discovery (MSD) Sector Imager: Signaling assays (e.g. pStat)
  • Proliferation, adhesion, apoptosis
  • ADCC, CDC, cytokine release and quantification
  • GPCR-related assays: pERK, b-arrestin recruitment, Calcium-signaling
Affinity determination
  • Biacore, Octet, KinExA: Affinity (KD) determination, koff ranking, kon & koff measurements, epitope binning
  • Meso Scale Discovery (MSD) Sector Imager: Solution Equilibrium Titration (SET) and highthroughput affinity screening/ranking
Flow cytometry and imaging
  • IntelliCyt HTFC: Cell surface binding, internalization, signaling (96- & 384-well format)
  • INCell Analyzer high content screening: Cell morphology, Internalization
Bead-based assays
  • IntelliCyt HTFC: Receptor-ligand interaction & binding inhibition, cross-reactivity screening, multiplexed binding assays
  • Kingfisher magnetic bead processing
Biophysical antibody characterization
  • Analytical Size Exclusion Chromatography (SEC): Monomer content
  • Hydrophobic Interaction Chromatography (HIC): Antibody hydrophobicity
  • Dynamic Light Scattering (DLS): Molecule radius determination
  • Antibody stress testing: pH, physical stress

Production and CMC

MorphoSys possesses profound experience in the area of manufacturing, the thorough characterization of new drug candidates and the execution of formulation and stability studies. The Company has performed high through-put manufacturing of monoclonal antibodies in more than 90 partnered and 13 proprietary projects including a seamless production of antibodies from µg to gram scale. Additionally, MorphoSys has signed strategic partnerships with various external service organizations for the GMP/GLP-related tasks to provide highest quality clinical trial material.

Regulatory affairs

MorphoSys has significant regulatory expertise in drug development for biologicals in Europe and the US. A strong network of EMA and FDA regulators and regulatory advisors is exploited to support the proprietary development programs with a focus on expedited programs (breakthrough therapy designation, fast track, accelerated approval) and orphan designations.

MorphoSys more recent regulatory track record includes the orphan drug and orphan medicinal product designation for its proprietary compound MOR208 in DLBCL and CLL as well as the fast track designation by the FDA in DLBCL.

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Preclinical development

MorphoSys's preclinical development team is applying high-quality standards to take therapeutic candidates from drug discovery to initiation of human clinical trials quickly and increase the success probabilities for each project. After programs have entered the clinic, their preclinical characterization continues with a focus on identifying additional indications or the most suited combination partners for clinical development.

Clinical development

MorphoSys provides an excellent clinical development team with around 60 members in its proprietary development segment. To date, MorphoSys has initiated and successfully led clinical trials at more than 40 clinical centers in 12 countries. The Company additionally supports investigator-sponsored trials to obtain a deeper understanding of its proprietary compounds.

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Development expertise

MorphoSys's clinical development team is committed to developing outstanding treatments for severe diseases.
Clinical Development Expertise

Clinical trials

More information on clinical trials MorphoSys is currently carrying out.
Clinical Trials