PIPPI — Protein-excipient Interactions and Protein-Protein Interactions in formulation

Results in brief

Protein-excipient Interactions and Protein-Protein Interactions in formulation

The increasing number of protein therapeutics on the market and in industrial pipelines drives the need for a better understanding of their formulation to meet emerging trends such as ultra-high protein concentrations, aggregate formation by novel formats, and train specialists in the growing biopharmaceuticals sector. This led to the formation of the ITN network PIPPI (Protein-excipient Interactions and Protein-Protein Interactions in formulation), where 15 Ph.D. students were trained within protein formulation, with an emphasis in biophysical and structural characterization of protein therapeutics. The consortium were located in Denmark, Sweden, Germany and United Kingdom. The students worked in an international and interdisciplinary network learning to combine systematic investigations of physicochemical behavior of a number of proteins with an in-depth understanding of the molecular interactions behind the macroscopic behavior. We have published a comprehensive database for diverse protein architectures, which can be interrogated for the prediction of their properties and stability when complemented with a minimum number of experiments. The database contains characterization results from both high throughput methods, structural characterization and in-silico methods. From the 32 articles published so far the synergy between experimental and computational methods and between high-throughput and low-throughput methods are clear.

Data: CORDIS, © European Union

Project objective

The revolution of biotechnology has led to the creation of various types of therapeutic biologics with the potential to provide treatment for new chronic and malignant diseases. Though the potential advantages of biologics lay in their high specificity and potency combined with few side effects, their formulation still remains a large challenge to pharmaceutical scientists. This is in part due to the complex, not-well understood relationship between the physicochemical properties of proteins and formulation conditions required for protein stability. A comprehensive understanding of the molecular mechanisms behind protein stabilization and solubility would provide the formulation scientists with knowledge of the interplay between formulation and stability that in turn could potentially make formulation development faster, cheaper and less labour intensive than the currently used broad screening approach. Understanding the susceptibilities of formulations to protein aggregation and denaturation can reduce the response time to for instance product failure. Few universities in Europe have formulation of biologics as a scientific subject. Consequently, the pharmaceutical industry is forced to train scientists - a challenge for larger companies, and an insurmountable task for smaller companies. Scientists in the field of structural biology, biophysics, protein formulation and stability have formed a consortium to systematically map physicochemical properties of biologics, formulation conditions and protein stability. The main objective of the consortium is to provide a new generation of innovative and entrepreneurial early-stage researchers that will develop methodologies, tools and databases to guide the formulation of robust biologics. The consortium will not only provide an excellent platform to train a new generation of formulation scientists, but also establish avenues for designing new formulation strategies and thereby securing the leading edge of EU expertise.

Original text from CORDIS.

Participants

DANMARKS TEKNISKE UNIVERSITET · Kongens LyngbyCoordinatorDenmark
KOBENHAVNS UNIVERSITET · KOBENHAVNDenmark
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN · PlaneggGermany
LUNDS UNIVERSITET · LundSweden
MAX IV Laboratory, Lund University · LUNDSweden
MEDIMMUNE LIMITED · CambridgeUnited Kingdom
NANOTEMPER TECHNOLOGIES GMBH · MUNCHENGermany
NOVOZYMES A/S · BagsvaerdDenmark
THE UNIVERSITY OF MANCHESTER · ManchesterUnited Kingdom
WYATT TECHNOLOGY EUROPE GMBH · DERNBACHGermany

PIPPI · Protein-excipient Interactions and Protein-Protein Interactions in formulation

Results in brief

Protein-excipient Interactions and Protein-Protein Interactions in formulation

Project objective

Participants

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