Bio APIs: accept the challenges

Highly effective solutions for more efficient bio API production

Get more out of your fermenter for a higher yield from your biotechnological processes. We offer a unique product and solution portfolio for the efficient production of bio APIs. From the incoming goods department to purification, we support you with a customized portfolio of solutions and expertise so that your biotechnological innovations also quickly become an economic success.

Incoming goods the correct solution at hand

Whether raw materials or packing materials, the cornerstones of your successful biological active ingredient production can be found in the incoming goods department. This department must be optimally managed, comprehensively protected, and thoroughly documented.

We support you with a broad portfolio of components and systems to efficiently meet all the requirements of the incoming goods sector. This includes our proven and flexible solutions for storage and material flow logistics; bar-code reader and radio-frequency identification (RFID) systems for the automatic recording of goods; and fire protection, safety, and building automation systems. The optimum interaction of all components and systems enables seamless and Good Manufacturing Practice-compliant documentation of all environmental conditions that a raw material was exposed to. You benefit from more efficient commodity flows, maximum transparency, and improved safety.

Laboratory optimally controlled

The requirements for modern laboratory management include the highest laboratory safety, greater process efficiency, and reduced effort in ensuring compliance with requirements such as 21 CFR Part 11. It is crucial to maintain the constant high quality of the products manufactured. For this purpose, we offer proven solutions for access control, building automation, and hazard management that ensure constant and safe environmental conditions. You can also optimize your entire laboratory workflow with our SIMATIC IT Unilab laboratory information management system, from sampling to performance that complies with US Food and Drug Administration (FDA) and EU regulations, and from documentation of the tests to the supported release of batches. And with Totally Integrated Automation, we enable the seamless integration of your laboratory into all existing control systems on the levels of the enterprise resource planning (ERP) system, manufacturing execution system (MES), and distributed control system (DCS).

Preparation foundation of successful fermentation

Preparation paves the way for a successful fermentation process. Only if inocula and media are available at all times in the correct quantity and quality can high requirements for product quality, safety, and productivity be met. During the inoculum preparation, we ensure optimum environmental conditions with our proven solutions for heating, ventilation, and air-conditioning (HVAC) control and clean-room monitoring. And with SIMATIC IT, our scalable and flexible manufacturing execution system (MES) offering, we enable effective management not only of your cell bank but also of all process-relevant raw materials. With our highly available drives, pumps, and controls, we enable efficient operation of mixing vessels during media preparation. And there is more: our flexible SIMATIC Batch recipe automation solution and the proven material management modules of SIMATIC IT allow us to optimize the entire media preparation process. We enable the automatic preparation of batches and the safe recording of all data on labels, 2-D bar codes, or radio-frequency identification (RFID) tags, for fewer rejects and greater transparency.

You benefit from improved quality and productivity along the entire process chain horizontally from the raw material to the product and vertically from the order to the batch.

Fermentation optimally controlled

Everything must be right in the core process of biological active ingredient production the quality of the raw materials and cell cultures, the environmental conditions, and, of course, the process management itself. Based on sophisticated energy supply systems and building technology, our scalable automation solutions ensure optimum control of the fermentation process in any production environment:

  • A cost-effective stand-alone solution is suitable for laboratories with the SIMATIC Microbox PC as the core and SIMATIC WinCC flexible as the HMI. (Figure)

  • For integrated fermentation processes, we offer a compact distributed control system (DCS) solution with SIMATIC PCS 7 Box, including controller and server. (Figure)

  • SIMATIC PCS 7 and SIMATIC Batch are the correct tools for integrated fermentation processes, with recipe automation for ISA-S88-compatible control of the fermentation process on any scale. (Figure)

  • For complete system solutions, we offer broad automation expertise in hardware, software, and project management, ensuring that your system runs efficiently and is seamlessly integrated into the production process. (Figure)

With these solutions, you can be certain that the start and framework conditions of your microorganisms or cell cultures are optimal at all times and that you can achieve exactly the harvest that you need at the end of the process, in the desired quantity and quality.

Harvest with consistent product quality

At the end of the fermentation process, cultures and solids must be separated quickly and efficiently from the nutrient solution. Precise motion control, high system availability, and consistent environmental conditions are the keys to cost-effective production. (Figure)

Purification reliable and safe

The cost-effectiveness of biological active ingredient production depends to a significant degree on the efficiency of the separation and purification process. All impurities must be removed quickly, reliably, and efficiently for consistent quality and maximum process yield.

Our continuous automation portfolio enables the seamless integration of your online and offline analytics. It is based on our highly available controls, powerful networks, and proven distributed I/O system. The SIMATIC PCS 7 process control system in combination with HMI hardware and software components ensures optimum control of the entire separation and purification process. We implement the next step toward higher performance with our customized process management solutions, PM Control and PM Quality.

Whatever degree of integration you select, the result is a clear increase in product quality and consistency even when raw material quality fluctuates. (Figure)

Reproducibility of batches

The reproduction of reliable results for every batch is a central challenge for bio API companies. Siemens supports the pharmaceutical industry with solutions and expertise to introduce Process Analytical Technology (PAT) into production. PAT is an important component for improved understanding of the process and improved control over product quality. PAT is the key to reproducible product quality and helps companies better meet the changing requirements of the regulatory authorities.