Comberbach Consulting — Clients and Testimonials

Comberbach Consulting has global experience, working with clients located on 4 continents since 2005.

MISSION

Documentation: government/1 year

DELIVERABLE

Concept study & economic evaluation of a vaccine fill/finish facility (remote & on-site)

LOCATION

Algeria


MISSION

Technical support: biotech company/1 year

DELIVERABLE

Supported process development & scale-up of anti-cancer vaccine candidate & oversight of 1st full-scale GMP batch production at CDMO (remote & on-site)

LOCATION

Australia


MISSION

Documentation: CDMO/3 month

DELIVERABLE

Updated site master file (remote & on-site)

LOCATION

Belgium


MISSION

VP Sterile Operations (interim): CDMO/6 month

DELIVERABLE

Managed GMP manufacturing of injectable cytotoxics, stabilised existing management & signed-up new clients (full-time on-site)

LOCATION

Belgium


MISSION

Chief Production Officer (interim): biotech company/18 month

DELIVERABLE

Managed process scale-up & full-scale GMP manufacture of orphan drug therapeutic protein for PhI/IIa clinical trials (full-time on site)

LOCATION

Belgium/Italy


MISSION

Technical support: biotech company/3 month

DELIVERABLE

Concept study & economic evaluation of a biopharmaceutical manufacturing facility (remote & on-site)

LOCATION

China


MISSION

Technical support: biotech company/3 month

DELIVERABLE

Concept study & economic evaluation of a stem-cell manufacturing facility (remote & on-site)

LOCATION

Egypt


MISSION

Technical support: biotech company/18 month

DELIVERABLE

Supported process development, scale-up and GMP manufacturing of recombinant anti-cancer vaccine (remote & on-site)

LOCATION

France


MISSION

Sterility Assurance Managing Consultant (interim): multi-national pharma company/18 month

DELIVERABLE

Supported Sterility Assurance in Quality Enhancement Project — 60% reduction in FDA observations compared with previous inspection (full-time on-site)

LOCATION

France/USA


MISSION

Technical support: government/1 month

DELIVERABLE

Supported CDMO selection for process development & GMP manufacturing of human vaccine for Ph I/IIa clinical trials (remote & on-site)

LOCATION

France


MISSION

Director of MSAT (interim): biotech company/3 month

DELIVERABLE

Managed 6 process development scientists — helped to achieve 40% yield improvement of a human vaccine manufacturing process (full-time on-site)

LOCATION

Germany/USA


MISSION

Technical support: biotech company/1 month

DELIVERABLE

Concept study & economic evaluation of a laboratory-scale recombinant human vaccine process (remote & on-site)

LOCATION

Germany


MISSION

Technology Program Director (interim): biotech company, 2 years

DELIVERABLE

Supported technology-transfer of a new industrial Acetone Butanol Ethanol process into an existing Ethanol manufacturing facility (remote & on-site)

LOCATION

India


MISSION

Technical support: biotech company, 3 month

DELIVERABLE

Designed mechanical foam separator using CFD & transferred proprietary design to manufacturer (remote)

LOCATION

Indonesia


MISSION

Technical support: biotech company/1 year

DELIVERABLE

Concept study & economic evaluation of a recombinant human therapeutic protein manufacturing facility (remote & on-site)

LOCATION

Malaysia


MISSION

Technical support: biotech company/2 years

DELIVERABLE

Concept study & economic evaluation of a human vaccine manufacturing facility (remote & on-site)

LOCATION

South Africa


MISSION

Head of Process Development & Industrialisation (interim): biotech company/1 year

DELIVERABLE

Managed 8 scientists developing a recombinant human vaccine process — progressed from laboratory to IMPD (first in human PhI/IIa clinical trials) in 11 months (full-time on-site)

LOCATION

Switzerland


MISSION

Technical support: multi-national pharma company/18 month

DELIVERABLE

Provided ongoing support for CDMO technology transfer, QC specifications, CQA’s & CMC document submission of bio-conjugate vaccine (remote & on-site)

LOCATION

Switzerland


MISSION

Technical support: biotech company/1 year

DELIVERABLE

Concept study and economic evaluation of human vaccine manufacturing facility (remote & on-site)

LOCATION

Thailand


MISSION

Director of Manufacturing (interim): CDMO/15 month

DELIVERABLE

Managed GMP manufacturing of sterile injectable biologicals, stabilised existing management & facilitated sign-up of new clients (full-time on-site)

LOCATION

UK


MISSION

Technology Program Director (interim): biotech company/1 year

DELIVERABLE

Managed Technology Strategy Board (TSB) project developing renewable fuels from Municipal Solid Waste (remote & on-site)

LOCATION

UK


MISSION

Technical support: biotech company/18 month

DELIVERABLE

Economic evaluation and Cost of Goods calculation for GMP manufacture of a prophylactic and therapeutic human vaccine (remote & on-site)

LOCATION

UK


MISSION

Technical support: biotech company/18 month

DELIVERABLE

Concept study and economic evaluation of an umbilical-cord blood cryogenic storage facility (remote & on-site)

LOCATION

UK


MISSION

Technical support: multi-national pharma company/3 month

DELIVERABLE

Supported process development, scale-up & process optimisation at GMP scale of a biosimilar recombinant human therapeutic protein (remote & on-site) 

LOCATION

UK


MISSION

Technical support: biotech company/2 years

DELIVERABLE

Supported process development & scale-up of recDNA human hormone-facilitated catalogue protein upgrade from research- to GMP-grade for import as a critical raw material into Europe (remote & on-site)

LOCATION

UK/USA


Client Comments

“Martin has made a difference to the organization and I thank him for helping us reach our full potential”

P Denis Celentano, Vice President and Site Head, Dynavax GmbH, Düsseldorf

“I would like to thank you for your efforts on this engagement and your contributions to the success of the project during the recently completed FDA inspection. The initial part of this process was very challenging and I recognise that your hard work and perseverance have paid off, and are much appreciated by us.”

Robert Spector, Tunnell Consulting Inc, USA

“Martin has made a major contribution to getting our first therapeutic protein into production by both his detailed knowledge and timely advice over the last 3 years”

John B Hawken, CEO, Immutep SA, France

“We were very pleased with the work Martin carried out for us. His work with a contractor provided an important element in its successful negotiation of inspections and audits”

Dr Richard Brydges, Process Development Manager, Microscience Ltd
Blue Violet