Selected recent Consulting assignments

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Minhai Vaccine Co., China

cGMP Audit (WHO; EMA) of a facility for production of HPV vaccine, including documentation (upstream/downstream/aseptic formulation and filling).

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Synbio Biotech Co, Belorussia

cGMP (WHO, USFDA) audit of an animal vaccine facility in order to verify whether a multipurpose biotech facility can be constructed at the existing site without regulatory implications.

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Rapharma Pharmaceutical Co, Russia

Application of directives in cGMP on segregated facilities (WHO, EMA) review of a multiproduct (cephalosporin, penicillin’s, cytotoxics) facility.

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PromMetic, UK

Process simulations of a plasma fractionation facility based on ProMetic´s proprietary process, analyzing production timelines operation sequences, debottlenecking and clean utility consumptions for an intended production capacity increase.

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Microgene Vaccine Co., Russia

Re-design and cGMP (EMA/PIC/S) review of an existing facility for bulk vaccine and pro-biotics production, including recommendations for segregation and containment.

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NKF Biochemical Co, China

Project aimed at exporting to EUR and USA, a cGMP audit (EMA, FDA) of an aseptic formulation and filling facility for the filling of recombinant LMW Heparin.

Impression

Galderma-Nestlé, Sweden

Development of a site master plan for a 15-years expansion program. Process expertise consultation for a brown field project, with a value of 18 MEuro, involving a biotech facility, including Drug Substance (API) and Drug Product (formulation and aseptic filling facility). Developing the containment strategy in line with current regulatory restrictions both in regards to product and operator protection (Botulinum, BSL 3).

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Karolinska University Hospital, Sweden

A consulting project in order to innovate and design the operating theater of the future in co-operation with the client’s physicians.

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Fresenius Kabi, Germany

KeyPlants provided guidance and recommendations for upgrading of an oral liquid nutritional plant for EMA-GMP Grade D compliance, i.e. addition of air locks, ventilation, flows, mix-up preventions, as well as operational routines.

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Octapharma, Sweden

Process simulations of Octapharma’s plasma fractionation facility based on its proprietary process analyzing capacities, production timelines operation sequences, debottlenecking and clean utility consumptions.