Production capacities for biopharmaceutical products, mostly antibodies, have been limited for decades. Production capacities are therefore being expanded worldwide. In addition, new, patient-based therapies, such as stem cell or CAR T-cell therapies, require new production capacities.
Whether large-scale microbial production of small molecules in bioreactors of 5 - 100 m3 or cell culture-based production in single-use technology, our interdisciplinary teams will support you in planning your production facility. We can draw on our know-how from successfully implemented projects.
Time-to-market as a critical element
In recent years, modern biotechnology has proven to be extremely dynamic, particularly in the field of process development. This can be seen in innovative production processes as well as in new areas of application. Optimized expression systems, improved harvesting and processing strategies and the trend towards highly automated, flexible and modular production units define the market.
As the development of innovative biopharmaceutical active ingredients is a cost- and time-intensive process, the "time-to-market" criterion plays the most important role alongside the safety and high quality of the production plant. The expected time to market has a considerable influence on the planning and design of biopharmaceutical plants.
Modern biotechnology is also having an increasing impact on the production of fine chemicals and food and food supplements.
Cost-critical active ingredient production
Biotechnological production processes are mainly defined by the biological system used. The system must fulfill the specific requirements that the respective cell type or microorganism places on the process. Optimum yields and cost-effective production can only be expected if the reactor system and the cultivation parameters, cell harvesting and processing are specially adapted to the cell type used and the often expensive and highly sensitive product. In addition to cultivation, product-specific processing plays a particularly important role.
Our specialist planners for biotechnology have the necessary specialist knowledge to be able to recognize and evaluate critical details of the process in discussions with our customers.
The basis for technology consulting by Chemgineering is always a combination of process engineering and plant planning know-how with special biotechnological expertise.
Informative simulation
Mapping the planned system in a process simulation at an early stage enables bottlenecks to be identified and simplifies the design of the containers. The simulation depicts cell cultivation with subsequent cell harvesting and processing as well as the functional units ultrapure media, CIP/SIP, buffer and media preparation through to inactivation and disposal. Failure and emergency scenarios allow critical parameters to be identified at an early stage. For example, the failure of the demineralized water network and its impact on the ongoing process can be investigated in detail.
Modern active ingredient production plants in the biopharmaceutical industry achieve their efficiency not least through considerable flexibility. Modular multi-product plants in particular meet the high demands of dynamic production strategies. The complexity and interdependencies of occupancy times, cleaning cycles and formulation procedures can no longer be optimally planned for multi-product plants without the use of the simulation tool. Only the realistic simulation of the expected process events, together with the correct dimensioning of the equipment and minimization of the containers, enables optimum plant planning.
Comprehensive expertise
Chemgineering has been able to demonstrate its expertise in these fast-growing market segments in many projects over the past few years. The references from well-known customers range from biotechnological vitamin production and the purification of blood plasma products to the production of bacterial vaccines. The size of the planned plants ranges from pilot plants for R&D with a size of a few liters to production plants with several 10,000 tons per year.
To ensure successful project execution, we combine bioprocess engineering expertise with the skills of process engineers from various disciplines. The respective project team, consisting of bioprocess engineers and pharmaceutical engineers, works together to solve recurring problems in the planning of (bio)pharmaceutical plants. The team is supported by specialists from the respective disciplines, who provide expert answers to questions relating to process automation, architecture (clean room planning, zoning) and the qualification and validation of plants and processes.
Only well-coordinated project teams with experienced project managers and qualified specialist engineers can master the extraordinary complexity of decision-making that is required from the planning to the execution of biopharmaceutical plants.
Successfully completed studies:
Scale-ups
Process assessments
Feasibility studies on technical and economic aspects
Technical due diligence and site assessments
Process simulations
Containers taking into account biosafety levels 1 to 3 (BSL 1- 3)
Microbial fermentation for the production of small molecules (vitamins, APIs)
Cell culture-based production of biopharmaceuticals
Protozoa for the production of enzymes
Car-T cells and stem cell expansion
Vaccines
The plans also include ancillary facilities such as:
CIP cleaning
SIP sterilization
Buffer and media production
Buffer storage and distribution
Production and storage of cell banks
Chemical waste water decontamination
Relevant Projects
New Facility HD15
60m³ Fermentation System
First plasma fractionation plant in Turkey
New glycoenzyme production
Recombinant Ebola Vaccine Production
Laboratory Retrofit and Microbiology Laboratory
Restructuring of plasma production and sterile filling
Cell and Gene Therapy
Feasibility study for a biotechnological production plant
New Cell Therapeutics Facility
Production Line for Algae
Concept study for a production line for Algae (Chlorella Vulgaris) as food supplement.
Customer
AlverWorld
Location
St. Aubin, Switzerland
Budget
Confidential
Year
1 Year
Mandate
Concept Study and Consulting
Services
Concept study:
Setup of a production line for algae as food supplement
USP, DSP, Utilities
Bioreactor-based production, following cell separation, buffer exchange, disintegration, drying
Consulting:
Concept development
Process development
Evaluation of Subcontractors
Evaluation of customized equipment
New Facility HD15
Planning and execution of a new plant (4 floors) for the production of natural products under high pressure conditions (supercritical CO2 up to 1,000 bar).
Customer
Hopfenveredelung St. Johann GmbH
Location
Wolznach, Germany
Budget
6 Mio. EUR (excl. Engineering Fees)
Year
3 Years
Mandate
General Planner
Services
Basic & detail engineering, support of the procurement process (tendering procedure, contract negotiations), construction management, support of commissioning
Chemical engineering departments: project management, HVAC incl. automation, process planning (building services, packaging unit, piping, 3-D model)
Special features: Process automation of the customer, relocation of existing process equipment (e.g. extraction system)
60m³ Fermentation System
Conceptual design for the implementation of an upstream and downstream process in an existing building. The project included a 90m² clean room, 270 m² fermentation area (60 ³ capacity), a tank farm and utilities.
Customer
Phyton Biotech
Location
Ahrensburg, Germany
Budget
30 Mio. EUR
Year
4 Months (Planning), 2 Years (Implementation)
Mandate
General Planner
Services
Project coordination and scheduling
Process: Mass and energy balance, blow flow diagram, process flow diagram, concept for waste water treatment
Layout planning / 3D modelling: Personnel and material flow, conceptual planning of utilities, HVAC and building
Supplier coordination for key equiment
Cost estimates
Automation concept
First plasma fractionation plant in Turkey
Planning of a plasma fractionation with 650,000 l / 1 million l (expansion) per year; basic fractionation, purification, fill & finish, products: IVIG, albumin, FVIII, each in different concentrations. Planning as a "sandwich concept", production-centered arrangement with the supply below and HVAC above.
Customer
Maxicells
Location
Isanbul, Turkey
Budget
Confidential
Mandate
General Planner
Services
Concept & basic design (completely 3D)
Tender design (all trades), tender procedures
Investment cost estimation, value analysis
URSs
Preparation of schedules
Procurement support
New glycoenzyme production
Planning of a production plant for endoglycosiadases (and in future also mRNA). Microbiological plant (yeasts and bacteria) with 30l / 300l (after expansion) fermentation volume. Planning as a classic upstream-downstream plant with single-use technology for fermentation and purification.
Customer
Daiichi-Sankyo
Location
Pfaffenhofen, Germany
Budget
Confidential
Mandate
General Planner & General Contractor
Services
Concept design, basic design, detail design
All trades
Investment cost estimation, value analysis
URSs
Preparation of schedules
Recombinant Ebola Vaccine Production
Conversion of a production facility, USP and DSP, for cell culture-based vaccine production, including adaptation of media, clean rooms, HVAC and chemical wastewater inactivation.
Customer
Janssen Vaccines AG (J&J, ex. Crucell)
Location
Bern, Switzerland
Budget
8. Mio EUR
Year
2 Years
Mandate
General Planner
Services
Concept design, process layout, basic design, incl. HSE and GMP reviews, detail design
Disposable equipment installation
Conversion of ventilation & media supply
Construction management and commissioning
Planning and implementation of chemical wastewater inactivation
Laboratory Retrofit and Microbiology Laboratory
Design of a new laboratory, microbiology laboratory, extension of an existing building during ongoing production.
Customer
GABA International AG
Location
Therwil, Switzerland
Budget
8.3 Mio. CHF
Year
1 Year
Mandate
Condept Study
Services
Requirements analysis, variant study
Layout and equipment planning
Personnel and material flow planning
Zone and airlock concept
Building concept
Ventilation concept
Safety concept
Cost estimate, realization concept and schedule
Restructuring of plasma production and sterile filling
GMP-compliant conversion of plasma processing (10,000 m2) incl. PM for new sterile filling.
Customer
Biotest Pharma GmbH
Location
Dreieich, Germany
Budget
50 Mio. €
Year
6 Years
Mandate
General Planner
Services
GMP concept development
Concept planning
Process description
Basic engineering
Project management
Detailed scheduling
ERP system implementation in production
Cleaning validation / media fills
Cell and Gene Therapy
Laboratory for cell and gene therapy, total area approx. 1800 m². Process transfer USA - Switzerland.
Customer
International Pharmaceutical Company
Location
Switzerland
Budget
15 Mio. CHF
Year
9 Months
Mandate
General Planner
Services
Basic Design
New extension and adaptation of existing building
Clean room extension
HVAC
EMSR
Building automation
Feasibility study for a biotechnological production plant
New construction of a factory for the production of food supplements; microbial fermentation, DSP, media & infrastructure.
Customer
Biotrend S.A.
Location
Milharado, Portugal
Budget
60 Mio. EUR
Year
2 Years
Mandate
Feasibility Study
Services
Process analysis
Process layout
Variant studies
Mass and energy balances
Building concept and building layout
Site master plan
Investment cost estimate
Production cost estimate
New Cell Therapeutics Facility
Concept design and engineering for a new production facility for cell therapies on an area of 1,000 m² (brownfield). Production of dendritic cells, CAR-T cells and lentiviral vectors. Main features: Flexible production - cell suites, production area for lentiviral vectors, QC labs, storage, cold chain management.
Customer
Pharos Vaccine Inc.
Location
Sangdaewon-dong, South Korea
Budget
8 Mio. EUR
Year
1 ear
Mandate
Concept Design, Engineering
Services
GMP: MFDS, US-FDA, EU-GMP
Concept Design (3D)
All Trades
Value Engineering
Cost Estimates
Creation of Time Schedules
If you have any questions about biotechnological production, please contact us
We help you to successfully implement your project.
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