Safety through
know-how.

A lifecycle of performance and trust

We design, plan, and build turnkey life science facilities

We are your absolutely reliable partner in realizing demanding high-tech facilities. We accompany you throughout the entire lifecycle of your systems, buildings, and the resulting products. You decide whether you want only sound advice, implementation of individual project phases, or if we may relieve you of any concerns as a dependable general planner and general contractor. Challenge us: in process engineering, architecture, technical building equipment, cleanroom construction, and the many other disciplines influencing the success of your products. Whether you are planning a completely new site or just optimizing subsystems – we offer you all the necessary disciplines and trades in-house for the implementation of your projects in all project phases. Characteristic of our service is always the most up-to-date know-how, diligence, highest commitment, and absolute identification with the goals and resources of our valued customers.

Consulting

Vision accomplished

Do your processes and existing process environments meet the latest standards and regulations? Are they secure and efficient enough to ensure your competitiveness even tomorrow? What technical, organizational, and financial consequences result from a renovation or new construction? Your concern is our challenge. We contribute with know-how, diligence, and a targeted view of future developments. The extensive experience of our specialists in a variety of different industry sectors as well as the respective regulatory environment gives you the certainty of being set up securely, efficiently, and future-proof. We support you, among other things, with plant development planning, feasibility studies, regulatory audits, and we enthusiastically open up alternative solutions, evaluate – technically and monetarily – and thus create reliable foundations for well-founded decisions. Our services:

Feasibility study
Plant development planning
Site selection/Due Diligence
Process simulation, consulting and optimization
Cost estimation
EU-GMP/FDA consulting/Gap Analysis

Design

We listen attentively, submit well-thought-out proposals and deliver flawlessly

We understand and design what you need. Promised! An intensive dialogue with well-prepared decision-making bases creates the foundation for this. Your specific requirements and particularities, an absolutely safe but effort-optimized operation, minimized but realistically estimated project durations as well as high flexibility and future security in the use of buildings and facilities are our technical and economic premises. We support you in all planning phases of your project – from design through approval to execution and assembly. As an experienced partner of many industries, our experts have enormous experience with the respective core processes. We know your regulatory environment and understand its guidelines. Our planning processes not only provide the required technology. We define ambitious but realistic goals, identify potential risks, and review alternatives with great commitment. Last but not least, we constantly question self-critically whether we are on the right track in terms of an optimal, future-proof solution. As a result, you receive not only optimal technology, but well-founded recommendations for action and ultimately a facility that sets long-term standards. Our services:

Concept planning, extended design and approval planning, execution and assembly planning as general planner or for individual trades:
- Process technology
- Architecture / extended shell construction
- Technical building equipment
- Cleanroom interior construction
- Laboratory technology
Building applications
Approval applications according to BImSchG

Execution Commissioning

We take it on and get it running – for you: hassle-free

Whether it’s a small renovation or a turn-key major project – we have your construction project fully under control. Know-how, experience and foresight, proven yet flexible work processes under a stringent quality management system form the secure foundation for this. Much of it is theory, but even more is practice. We are not only excellent engineers, but above all hands-on practitioners who enormously enjoy what emerges in the implementation of our technical designs. That’s why we offer not only modular control, planning and consulting services as part of the tendering, assembly and commissioning process, but also proven networks of high-quality, reliable partners in execution. This is not least to be able to optimally fulfill our role as general planner and general contractor. The more complex the task, the greater the demand for truly well-coordinated teams. With us, in-house architects, planners and engineers from all trades who have truly mastered turn-key projects as a team over decades will look after you. The result is always a smooth project flow and optimized use of resources. We deliver solutions absolutely reliably and with full commitment to the technical goals and budget of our customers. Our services:

Turn-key realization of projects as general contractor
Contract scenarios:
- Fixed price contract
- Open book contract
- GmaxP contract
Cross-trade construction and project management (quality, costs, schedule)
Specialized construction management, shutdown, management
Commissioning

Qualification validation

No more question marks, no worries and no risks

With professional qualification and validation, we create documented proof that the production facility and product always meet the required quality standards. In this process, we identify potential weaknesses, assess risks and – when necessary – create reliable but cost-effective optimization opportunities. We always keep the requirements of approval and inspection authorities in mind. We document all qualification and validation work according to internationally valid and current guidelines. We achieve the operating and manufacturing permit for your facilities and products quickly and, above all, with planning certainty. For existing production facilities, we organize audits and develop GMP and FDA-compliant optimization proposals. The result is a safe product. Our services:

Risk analyses
Installation Qualification
Operational Qualification
Support with PQ
Operator training

Facility management

When you simply don’t have to go and check yourself

Our primary concern is the creation of absolutely long-term value-retaining and, in the best case, flexibly usable plant systems. In addition to future-proof solutions in design and implementation, we therefore offer extensive support services tailored to the wishes of our customers. Proactive provision of process-critical replacement components, competent and quick troubleshooting as well as carefully preventive measures in the context of inspections, maintenance, optimization and remote monitoring are just some of our standards. All this, of course, around the clock and connected to our 24/7/365 service hotline. The result is always a cost-optimized but absolutely safe plant operation as well as the maximum extension of the lifespan of your facilities. With regular re-qualifications, we secure and document the GMP-compliant condition of quality-critical systems. Our services:

Maintenance/Troubleshooting service
Re-qualification/Calibration
Cleanroom measurements
Warranty management

In perfect harmony with your process

Process know-how Biotechnology / API production

We cover the complete life cycle of your product, from the initial idea through laboratory scale to large-volume commercial production of both mono- and multi-product facilities. Depending on customer requirements, we plan processes in single-use technology, stainless steel plants or hybrid variants.

Our process specialists have many years of process expertise in the following areas:

Biopharmaceuticals
Products based on cell culture fermentation or microbial expression systems (e.g. monoclonal antibodies)
Vaccines
Blood plasma
Tissue engineering
Diagnostics

We plan your process facilities from upstream (fermentation, media preparation, harvesting) through downstream (buffer preparation, storage, purification) to formulation and filling as well as storage including the required process infrastructure such as:

Pure media systems (purified water, water for injection, clean steam etc.)
CIP/SIP systems
Process gases
Wastewater inactivation/wastewater treatment systems
Exhaust gas treatments

In this process, we consider and integrate cGMP requirements, the required BSL level, and EHS standards in the planning. Of course, all these services are part of our ability to deliver turnkey facilities. Challenge us!

In perfect harmony with your product

Our process specialists support you in the areas of compounding, fill finish, and packaging

Based on your requirements, we plan and define the appropriate process equipment and coordinated technologies for your products. In doing so, we consider all regulatory requirements as well as investment and operating costs.

Our specialists have extensive experience in the production of:

sterile and aseptic products
cytostatics
solid dosage forms
semi-solid dosage forms
liquid dosage forms

We plan your processes from the manufacturing pharmacy to large-volume pharmaceutical production, including the necessary process infrastructure such as: