Modern biotechnology has proven to be a highly dynamic field in recent years, especially in the area of process development. This is shown both by innovative production processes and ground-breaking applications. Optimized expression systems, improved harvesting and processing strategies, and the trend toward highly automated, flexible and modular production units are dominating this market.

Because the development of innovative active biopharmaceutical ingredients is a cost- and time-intensive process, time-to-market is the most important criterion together with the safety and high quality of production installations. The expected time span to market launch has a strong influence on the planning and construction of biopharmaceutical plants. Modern biotechnology is also starting to affect the production of fine chemicals, foods and food additives.

Cost-critical production of active ingredients
Biotechnological production processes are defined primarily by the biological system employed. The plant must fulfill the specific requirements imposed on the process by the particular cell type or microorganism. Optimal yields and low-cost production can be expected only if the reactor system and its cultivation parameters, the cell harvest and the processing are specially adapted to suit the cell type employed and the product, which is frequently expensive and highly sensitive. Product-specific processing is especially important, as is cultivation.

As specialist designer for biotechnology, Chemgineering possesses the necessary special knowledge to be able to pick up on the critical details of the process in the discussion with our clients and to evaluate those details.

The basis for technology consulting by Chemgineering is always a combination of process engineering and plant design know-how, together with Chemgineering's special biotech expertise.

Extremely useful simulation
The planned production plant is replicated at an early stage in a process simulation. This permits the identification of bottlenecks and simplifies dimensioning of the vessels. The process simulation replicates the cell cultivation with subsequent harvesting and processing as well as the function units of ultrapure media, CIP/SIP, buffer and media preparation all the way to inactivation and waste disposal. Malfunction and major accident scenarios permit early identification of the critical parameters. For example, the failure of a VE water network and its effect on the ongoing process can be investigated in detail.

Modern active ingredient production plants in the biopharmaceutical industry owe their efficiency not least to a high level of flexibility. In particular, modular multi-product installations meet the demanding needs of dynamic production strategies. The complexity and interdependency of production times, cleaning cycles and the operating requirements of different formulations cannot be planned optimally for multi-product installations without using the simulation tool. Only the realistically duplicated, expected process sequences open the way to optimal equipment planning based on correct dimensioning of the apparatus and minimization of the vessels.

Comprehensive expertise
In recent years, Chemgineering has had the opportunity to apply its know-how in this fast-growing market segment in a large number of projects. The relevant reference list includes leading firms in the production of biotech vitamins, the purification of blood plasma products, and the production of bacterial vaccines. The facilities have varied in size from pilot plants for R&D involving just a few liters all the way to production plants with capacities of several 10,000 tonnes per year.

For the successful handling of projects in this field, we supplement biotech process expertise with the knowledge of process engineers from a variety of disciplines. The ad hoc project team, comprising biotech process engineers and pharma engineers, works together in solving the recurrent problems involved in the design of (bio)pharmaceutical plants. The team is assisted by specialists in process automation, architecture (cleanroom design, zoning), and in the qualification and validation of the plants and processes.

It takes well-coordinated project teams with experienced project managers and qualified specialist engineers to tackle the extremely complex decisions faced in the design and construction of biopharmaceutical plants.