Let’s Reach Your Development Milestones Together

Ulrike Konrad, MBA

Director, CMC Expert on Biopharmaceuticals and Cell and Gene Therapy Products

Ulrike graduated with a Diploma in Chemistry and MBA after studying at universities in Germany and USA. She started her professional career as a scientist at a biotech company before transitioning to various business development positions. Since 2012, she has led ProtaGene’s international business development activities.

Why work with her:

  • 15 years of experience in biopharmaceutical development
  • Strong communication skills
  • Knowledgeable about cell line development, USP, DSP development, manufacturing, and corresponding analytics
  • Broad understanding of solid analytical layouts for your program

 

Her expert knowledge about biosimilar development, molecules, companies, and regulatory perspectives will guide project discussions and strategies. Whether you are interested in entering the EU market and need EU release testing or you need to demonstrate biosimilarity, contact her!

Analytical Solutions from Research to Market

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Research
Preclinical
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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

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Phase I
Phase II
Phase III
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Phase I – Phase III

Release, Clinical Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

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Registration
Market
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Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Biologic Therapeutics
Platform Expertise

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    mAbs

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    Bispecifics/Multispecifics

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    Recombinant Proteins—Including Complex, Highly Glycosylated Proteins

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    Multi-subunit Complexes—Protein, Nucleotide, Ligand

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    Fusion Proteins

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    Enzyme Replacement Therapies

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    ADCs and Protein Conjugates

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    PEGylated Proteins

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    Biosimilars

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    Vaccines, Including Subunit/Recombinant

Cell and Gene Therapeutic Platform Expertise

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    Capsid-based Vectors

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    Complex, Envelope Vectors

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    Non-viral Vectors

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    Genetic Engineering