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Reference Projects

Establishment of a new manufacturing process in a mulitproduct-facility for recombinant Insulin Aspart

 

Partner: SANOFI Aventis Deutschland GmbH

Project duration: October 2018 – Mai 2020

Project Scope: Implementation of a new manufacturing process for a new recombinant Insulin Aspart

IMPROCESS services included

– support for PPQ preparation
– statistical data evaluation for downstream process improvement
– optimized process parameters for manufacturing operations (Downstream)
– Creation of Cleaning and Process validation documents
– Process Improvement downstream processes (Protein Refolding, Protein Precipitation, Protein separation)
– Support for Engineering Runs
– Creation  of Plan-/Report for Engineering Runs
– Support of Commissioning / Manufacturing Start-Up
– Update Segregation concept for multiproduct equipment (Downstream)
– Consulting for Insulin as a Biologic (FDA)

Voice of the Customer

“IMPROCESS enabled us to have a new view on our current manufacturing operations from a biological manufacturing standpoint. Due to the new regulatory framework for Insulin as a Biologic IMPROCESS supported us to establish a new product manufacturing process in a multi product facility. Working with IMPROCESS has been a fruitful cooperation shaped by mutual respect, professionalism and know-how without disregarding the situation on site or our employees. We will be happy to work with IMPROCESS in the next projects to come.”

Dr. Christoph Hoh, Manufacturing Head Mulit-Insulin-Betrieb Industriepark Hoechst Sanofi-Aventis GmbH, Frankfurt/Main

“Working with IMPROCESS consultants was fun from the very beginning.Straight to the point, uncomplicated and equipped with the necessary technical know-how IMPROCESS always delivered the necessary quality to advance our project.”

DI Sandra Malzacher, Associate Manufacutring Head Mulit-Insulin Betrieb Industriepark Hoechst Sanofi/Aventis GmbH, Frankfurt/Main

Formulation equipment recombinant blood coagulation factor 8

Partner: CARPUS+Partner AG (for BAYER AG)
Project duration: March 2017-April 2018

Project Scope: Detail Engineering support, Installation and Commissioning for Formulation Equipment for recombinant factor 8 in a tech transfer project from the US to Germany

IMPROCESS services included

– Lead of engineers (customer, supplier)
– Ensured GMP compliant (DQ) installation by supplier
– Supervision of installation to ensure correct, error-free and GMP compliant installation by supplier
– Technical check (GMP) of supplier documentation
– Claims Management
– Contract Management
– Single-Point of Contact for Process Owner for Formulation work package
– Commissioning support
– Change Control for technical changes
– Deviation Management

Our support services and our expertise enabled our customer to successfully complete the project.

Voice of the Customer

IMPROCESS GmbH services allowed us to hand over a GMP compliant equipment according to DQ requirements. In this highly regulated and complex Biopharma environment IMPROCESS showed us the path to success. Despite the challenging project environment we had a lot of fun working with IMPROCESS consultants. We will be very happy to join forces with IMPROCESS highly qualified, reliable and trustworthy consultants in future projects.

Dipl. Ing. Jochen Schumacher, Head of Process Planning Carpus+Partner AG, Aachen

IMPROCESS showed us how to reach our project goals faster and more successfull in a highly regulated and complicated project environment.

Sönke Morgenstern, Partner / Prokurist, Head of Technology + Process CARPUS+Partner AG, Aachen