Contact us
Contact us
+49 911 376737-0
info@otto-lse.com

A Life Cycle of Performance and Trust

WE DESIGN, PLAN AND BUILD TURNKEY LIFE SCIENCE FACILITIES.

We are your absolutely reliable partner for the realisation of demanding high-tech facilities. Thereby, we support you over the entire life cycle of your systems, buildings and the products produced with these. You decide whether you would only like well-founded advice, individual project sections should be implemented or we may relieve you of all worries as reliable general planner and general contractor. Challenge us: in process technology, architecture, technical building equipment, clean room upgrading and the many other disciplines that influence the success of your products.

Whether you are planning a completely new site or only the optimisation of subsystems – in all project phases, we provide you with all required disciplines and trades for the implementation of your projects in-house.

Characteristic for our service thereby are always current know-how, diligence, maximum commitment and the absolute identification with the objectives and resources of our valued customers.

  • Vision accomplished

    Do your processes and your existing process environments comply with the latest standards and regulations? Are they reliable and efficient so that your competitiveness is still also guaranteed tomorrow? Which technical, organisational and financial consequences arise from a conversion or new construction?

    Your concern is our challenge. We participate using know-how, diligence and the targeted view for future developments.

    The extensive experience of our specialists in many different industrial areas and the respective regulatory environment creates the certainty for you of being positioned securely, efficiently and prepared for the future.

    Among other things, we support you for factory development planning, feasibility studies, regulatory audits and actively provide you with alternative solutions, evaluate – technical and monetary – and thus create reliable foundations for informed decision making.

    Our Services:

    • Feasibility Study
    • Factory Development Planning
    • Site Selection/Due Diligence
    • Process simulation, advice and optimisation
    • Cost Estimation
    • EU-GMP-/FDA Advice/Gap Analysis

     

  • We listen carefully, propose thoughtfully and deliver flawlessly

    We understand and design what you need. Promised! An intensive dialogue with well-prepared decision bases creates the basis for this.

    Your specific requirements and special features, absolutely reliable but cost-optimised operation, minimised but realistic estimated project durations as well as high flexibility and future security in the use of buildings and systems are our technical and economic premises.

    We support you in all planning phases of your project – from the draft to the approval to the execution and the assembly. As experienced partner of many industries, our experts have vast experience with the respective core processes. We know your regulatory environment and understand its provisions.

    Our planning processes provide not only the required technology. We define challenging but realistic objectives, identify potential risks and check alternatives with great dedication. Last but not least, we constantly question self-critically whether we are on the right path for the purpose of an optimal, future-proof solution.

    As a result, you obtain not only optimal technology but also well-founded handling recommendations and finally a facility that sets long-term standards.

    Our Services:

    • Conceptual design, extended draft and approval planning, execution and assembly planning as general planner or for individual trades:
      • Process technology
      • Architecture/extended shell
      • Technical building equipment
      • Clean room interior finishing
      • Laboratory technology
    • Planning applications
    • Permit applications according to BImSchG (German Immission Control law)

     

  • We take it over and make it work – for you: hassle-free

    Whether small conversion or turnkey large project – we have your construction project completely under control. Know-how, experience and foresight, proven and yet flexible work processes under a strict quality management system form the secure foundation for this. There is a lot of theory there, but even more practical experience. We are not only outstanding engineers but mainly also hands-on practitioners with a lot of enjoyment in what arises in the implementation of our technical designs. Therefore, we provide not only modularly available control, planning and advisory services in the framework of the award of contract, assembly and start-up but particularly also proven networks of high quality reliable partners in the execution. This, last but not least, to be able to optimally fulfil our role as general planner and general contractor.

    The more complex the task, the greater the requirement for really well coordinated teams. You are supported by our in-house architects, planners and engineers of all trades who have really mastered turnkey as a team over decades. The result is always a smooth project process and the optimised use of resources. We provide solutions absolutely reliably and with full commitment for the technical objectives and the budget of our customers.

    Our Services:

    • Turnkey realisation of projects as general contractor
    • Contract scenarios:
      • Fixed price contract
      • Open book contract
      • GmaxP contract
    • Multi-trade construction and project management (quality, costs, schedule)
    • Site management, shutdown, management
    • Commissioning

     

  • No leftover question marks, no worries and no risks

    With the professional qualification and validation, we create the documented proof that production system and product comply with the required quality standards at any time.

    In this process, we identify potential weaknesses, assess risks and – if necessary – create reliable but low-cost optimisation options. In doing so, we always proactively keep in mind the requirements of approval and inspection authorities.

    We document all qualification and validation work in accordance with internationally applicable and current guidelines. We obtain the operation and manufacture permission for your systems and products quickly and above all for reliable planning. We organise audits and develop GMP and FDA compliant optimisation proposals for existing production systems. As a result, you obtain a reliable product.

    Our Services:

    • Risk Analyses
    • Installation Qualification
    • Operational Qualification
    • Support for PQ
    • Operator Training

     

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

    Our top priority is the creation of long-term sustainable and in the best case also flexibly usable plant systems.

    As well as the design and realisation of future-compatible solutions, we therefore also provide comprehensive support services that are adapted to the requirements of our customers.

    Foresighted provision of process-critical replacement components, competent and quick fault clearance and careful preventive measures in the framework of inspections, servicing, optimisation and remote monitoring are only some of our standards.

    All of this of course around the clock and connected to our 24/7/365 Service Hotline.

    The result is always cost-optimised but absolutely reliable plant operation and the maximum extension of the service life of your plants.

    We ensure and document the GMP compliant condition of quality-critical systems with regular requalifications.

    Our Services:

    • Maintenance/Troubleshooting
    • Requalification/Calibration
    • Clean Room Measurements
    • Warranty Management

     

In perfect tune with your process

Process Know-how Biotechnology/API Manufacture

We cover the complete life cycle of your product, from the initial idea to the laboratory standard to the high-volume commercial manufacture, both of single product as well as multiple product plants. In doing so, we plan processes depending on the customer requirement in single-use technology, stainless steel plants or hybrid variants.

Our process specialists have many years of process competence in the 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 plants from the Upstream (fermentation, media preparation, harvest) to the Downstream (buffer preparation, storage, purification) to the formulation and filling and the storage including the required process infrastructure such as:

  • Pure media systems (purified water, water for injection, clean steam, etc.)
  • CIP / SIP systems
  • Process gases
  • Waste water inactivation / waste water treatment systems
  • Exhaust gas treatment

Here, we consider and integrate GMP, required BSL Level and EHS standards requirements in the planning. All these services are, of course, part of our capability to realise turnkey facilities. Challenge us!

In perfect tune with your product

Our process specialists support you in the Compounding, Fill & Finish and Packaging areas.

Based on your requirements, we plan and define the appropriate process equipment and matched technologies for your products. In doing so, we take account of all regulatory requirements and the investment and operating costs.

Our specialists have extensive experience in the manufacture of:

  • sterile and aseptic devices
  • cytostatics
  • solid dosage forms
  • semi-solid dosage forms
  • liquid dosage forms

We plan your processes from the manufacturing pharmacy to high-volume pharmaceutical production including the required process infrastructure such as:

  • Pure media systems (purified water, water for injection, clean steam etc.)
  • CIP / SIP systems
  • Process gases
  • Waste water inactivation / waste water treatment systems
  • Exhaust gas treatment

All these services are, of course, part of our capability to realise turnkey facilities. Challenge us!

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Contact

OTTO Life Science Engineering GmbH
Forchheimer Straße 2
D-90425 Nürnberg

Tel.: +49 (0) 911 376737-0
Fax: +49 (0) 911 376737-99
info@otto-lse.com

Certified

Management System ISO 9001:2015