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Process Development and Optimization

Process Development

The development of new products is often a long-term process and its outcome usually remains unclear until late in the process. Since patent protection is limited in time, new products must be brought to market quickly. This means that plants often have to be planned or adapted quickly. With the help of simulation software, we plan new processes in existing or also new plants.

When developing new processes, the optimal sizes of the infrastructure for operating resources (utilities) and process plants can be determined. Thanks to the holistic approach, including resources such as personnel and materials, investment and operating costs can be determined and compared under different conditions. Existing plants can be examined for their compatibility with new processes. Different scenarios can be simulated and viewed virtually without costly and time-consuming investments. A comparison between, for example, flexible single-use and fixed piping systems, can be an important decision-making aid in the early project phase.

We have the necessary know-how in the field of process development, system planning, clean room construction and infrastructure planning (building services engineering). In this way, cross-competence processes can be planned in a coordinated manner, and you benefit from tailor-made, holistic solutions. Thanks to the holistic approach, investments can be planned in a cost-optimized manner without incurring additional costs in other parts.

Process fitting

Based on the process parameters, which are specified by the customer, we plan the process plant around the process. Volumes, filter sizes, velocities, etc. are determined in the simulation model, and equipment, resources and infrastructure are dimensioned and specified accordingly. In this way, different scenarios can be compared with each other and optimal customer-specific solutions can be developed. Thanks to the cooperation with the engineering team, the process and the infrastructure are perfectly matched.

Production planning

The simulation can be used to evaluate the operating costs and resource consumption under different conditions. For example, you can see how much staff is needed if campaign sizes and cycle times change or if a new process can be fitted into the existing production planning.

can be fitted into the existing production planning Various factors are taken into account, such as personnel readiness, storage locations, availability, storage, etc. of raw materials and products.

    Process Optimization

    With the ever-increasing demands for cost and time savings, systems and processes must become more and more efficient. Therefore, OEE values (Overall Equipment Efficiency) and MTBF (Mean Time Between Failure) have become very important in the pharmaceutical industry. The complexity, variability and high cleaning requirements in this industry make optimization a major challenge.

    We offer you an interesting approach to meet this task in a professional manner:

    We use the existing knowledge from the field of process development and process simulation to carry out holistic end-to-end considerations of your processes. This way we can show you the best possible plant/resource configurations to run processes efficiently. Investment and operating costs, process specifications, plant flexibility and GMP requirements, as well as input and output to upstream and downstream processes are taken into account. Thanks to the evaluation of different scenarios, the optimal solution can be determined. You benefit from perfectly utilized equipment/resources, improved processes, and optimized operating costs.

    Considering the infrastructure, the process and the relevant resources, the minimum batch cycle time is determined. The process simulation model allows to analyze the influences of new equipment and to evaluate the optimal plant utilization. Investment and operating costs can thus be compared directly with the increasing production capacity. Production bottlenecks can be identified (de-bottlenecking) and possible solutions can be analyzed directly in the model. The influences of plant modifications are thus made apparent before costly and time-consuming conversions are carried out.

    Scale-Up

    For planning scale-ups, the overlaps of supply and demand can be evaluated under different scenarios. Thanks to the optimal design of the resource infrastructure, production bottlenecks can be prevented.

    Production planning

    Batches, campaigns, and maintenance are planned in such a way that the plant capacities are optimally utilized (mono- or multi-product plants). Various factors are taken into account, such as personnel readiness, storage locations, availability, storage, etc. of raw materials and products.

    Reference projects

    • Planning of a new process in an existing plant, Lonza AG, Portsmouth (USA)
    • Planning of a new single-use DSP line, BioArk SA, Monthey (CH)
    • Planning of a new multi-product plant, Middle East
    • Planning of a new filling plant, swissfillon AG, Visp (CH)
    • Process simulation for doubling the batch size of an ADC (antibody drug conjugate) plant, Lonza AG, Visp (CH)
    • Process optimization of mammalian production, Lonza AG, Portsmouth (USA)/Singapore (SGP)/Porriño (ESP)
    • Production planning, Bio Products Laboratory Ltd, London (UK)
    • Production planning of cell therapy production facilities, confidential (CH, USA)
    • Optimization of plant utilization for a vaccine producer, confidential (DE)

    pixon uses SchedulePro for production planning and SuperPro for process optimization. Both are from Intelligen, Inc. Both are from Intelligen, Inc.