Feasibility study and fast track implementation preparation for COVID-19 vaccine manufacturing capacity upgrading.
Feasibility study, including conceptual design and make or buy assessment for microbial single-use launch and market supply facility for engineered toxin bodies (ETB’s).
apceth Biopharma, D
Conceptual design for expansion of contract manufacturing for cellular therapy facility (MCS’s).
Canton Biologics, PRC
Conceptual design for contract manufacturing facility for recombinant proteins based on cell culture.
Feasibility study including cost modelling for contract multi-purpose clinical/market supply manufacturing facility based on hybrid stainless steel and single-use technology. Advisor to the project steering group.
Investment and operating cost study for comparing integrated continuous antibody production based on non-steady state low volume perfusion and online capture, virus inactivation and flow-thru purification with continuous high volume perfusion with SMB capture and with fed-batch/batch purification.
Halix b.v., NL
Rework of conceptual design for contract multi-purpose clinical/market supply manufacturing facility for up to BLS3 vaccines and recombinant proteins entirely based on single-use technology.
Enzene Biosciences, India
Process and investment study for continuous antibody production based on single-use technology.
CPL Biologicals, India
Investment planning to implement VLP vaccine manufacturing.
Process and investment study to implement inclusion body production based on single-use technology.
Confidential, BRIC(k) countries
Conceptual Design for template biopharmaceutical manufacturing module for BRIC(k) countries.
Preliminary design for a development and market supply facility for gene therapy products.
Detailed design and equipment procurement for clinical/launch manufacturing facility monoclonal antibodies entirely based on single-use technology.
CMO control (technical and quality) for manufacturing of enzyme for enzyme replacement therapy.
Cost simulation for fusion protein portfolio for market supply. Note: Perfusion
Manufacturing cost optimization and refurbishment planning for Japanese facility within international manufacturing network.
Amgen Research Munich, D and Thousand Oaks, USA
Cost simulation in preparation for bi-specific T-cell engager (BiTE) market supply. CMO control during PPQ lots.
Identification and auditing of developer/CMO’s for biosimilar alpha Interferon development and manufacturing.
Conceptual Design for Capacity Upgrading an existing fill finishing facility and building another one next to an existing distribution center
Novartis Vaccines, Marburg, D
Scope development for multi-product microbial bulk vaccine manufacturing facility.
Crucell CH, Bern, CH
Inspection preparation program for PER.C6 – adenovirus based vaccine bulk production and fill & finishing Note: Perfusion
Eisai Co., Ltd., JP
Cost model and expertise for manufacturing monoclonal antibodies using a novel transgenic technology.
Wilex AG, Munich, D
Selection of manufacturing partner for worldwide manufacturing therapeutic monoclonal antibody product for market supply. Note: Perfusion
Rentschler Biotechnologie GmbH, Laupheim, D
Basic and Detailed Design including Project Management for implementing 1000 L scale contract manufacturing facility primarily intended to manufacture monoclonal antibodies entirely based on single-use technology. The facility became ISPE Facilities of The Year - Category Winner for Equipment Innovation
Cerberus Capital Management Inc., USA
Technical due diligence for the take-over of major pharmaceutical manufacturing and development facilities (>5000 people) as part of a merger / divesture program.
Centre d'Immunologie Pierre Fabre (CIPF), F
Conceptual design study for implementing monoclonal antibody clinical production facility using single-use technology at 1000 L scale.
MorphoSys AG, Munich, D
Manufacturing strategy for manufacturing therapeutic monoclonal antibodies for clinical trials and market supply. Integration of strategy with master-plan development for R&D center.
Reliance Life Sciences, Mumbai India
Project User Requirements Specification for large-scale cell culture facility.
Synthon B.V., NL
Business strategy for entering the field of biosimilar monoclonal antibody development and manufacturing. After only six years the first project was licensed out to Amgen and Watson successfully.