Assessment of Manufacturability and Safety to Reduce Risk


Bringing Discovery and Development together

The path from discovery to commercialization is long and expensive. Unsatisfactory physical and chemical properties of biopharmaceutical candidates could lead to failure of the project during late-stage development or clinical trials.

Developability is an assessment of the suitability of a biological candidate to be successfully developed into an effective therapy. Can the candidate be manufactured, formulated for the appropriate route of administration and provide the desired pharmacology and pharmacodynamic characteristics?

Protagen Protein Services (PPS) provides comprehensive and state-of-the-art developability assessment service for your biopharmaceutical candidates, in order to address potential manufacturing and safety risks at the early stages of the discovery and development processes can build quality into your product, by design.

Why is developability assessment necessary?

Developability helps to reduce the gap by designing or engineering biopharmaceutical candidates to optimize efficacy, safety and quality can promote reduced costs and timelines and increase success rates.

The approach of developability assessment is on:

  • Reduce attrition rates
  • Improve efficacy and safety
  • Focus on most promising candidates
  • Maximize the output of R&D investment
  • Reduce cost and time to market
  • Improve product quality, by design

What developability assessment concerns about?

Developability assessment can be considered as the extension of the QbD (quality by design) guidance, providing a bridge between product knowledge and process understanding.

Our approach consists of two modules: a preliminary screening stage and a comprehensive assessment stage. According to the magnitude of your drug candidates to be evaluated, one or both of the service modules could be chosen to guide your choice of lead candidate for further process development.

  • Clone selection: MS-based multiple attribute monitoring (Seq, PTMs), Glycan profile
  • Manufacturing/Upscaling: Sequence analysis, PTMs, Glycan profiles, Disulfide bonding, higher order structure, Drug-derived impurities, aggregates, Process-derives impurities, HCPs, critical quality attributes (CQA), bioassays to address efficiency,

Also it implements comprehensive investigation to assess manufacturing feasibility (productivity, stability, aggregation, etc.), formability for a specific administration route, and compatibility with in vivo environment, such as immunogenicity, off-target effect, and half-life.

Your Contact for Developability

please call us +49 (0) 231 9742 6100

Dr. Thomas Flad

Head of Business Development
South Germany, DACH Region