Roth BioProcessing Consulting
Consulting firm focused on development and manufacturing strategies for complex biologics, with particular expertise in live viral vectors, recombinant proteins and CMC-related topics. Services include process development (with an emphasis on upstream), CMO selection and oversight, technology transfer, facility design and due diligence for transactions and investments. Operates with international reach and a network of industry experts.
Industries
Nr. of Employees
small (1-50)
Roth BioProcessing Consulting
Services
Advisory on expression system selection, in-house vs outsourced manufacturing decisions and lifecycle manufacturing strategies considering regulatory constraints.
Identification and selection of appropriate CMOs, negotiation support and management of technology transfer to external manufacturers.
Upstream-focused process development, process analysis, troubleshooting and optimization to improve yield and reproducibility.
Technical and operational due diligence for product, facility or company transactions; advisory support for acquisitions and divestitures.
Services covering development, manufacturing and regulatory considerations for live virus manufacturing intended for clinical use.
Advisory on design and planning of biomanufacturing facilities and support for facility acquisition or divestment decisions.
Advisory on expression system selection, in-house vs outsourced manufacturing decisions and lifecycle manufacturing strategies considering regulatory constraints.
Identification and selection of appropriate CMOs, negotiation support and management of technology transfer to external manufacturers.
Upstream-focused process development, process analysis, troubleshooting and optimization to improve yield and reproducibility.
Technical and operational due diligence for product, facility or company transactions; advisory support for acquisitions and divestitures.
Services covering development, manufacturing and regulatory considerations for live virus manufacturing intended for clinical use.
Advisory on design and planning of biomanufacturing facilities and support for facility acquisition or divestment decisions.
Expertise Areas
- Viral vector development and manufacturing
- Upstream bioprocess development
- CMC strategy and implementation
- Technology transfer and CMO management
Key Technologies
- Viral vector production
- Upstream bioprocessing
- Recombinant protein production
- Post-expression modifications (PEGylation)