Process Analytics in Biotechnological and Pharmaceutical Industries
Biopharmaceutical manufacturing is generally characterized by the use of advanced technologies, harnessing of new scientific advances, and driven by a highly complex research and development enterprise.
For decades, Knick has been advising and supporting companies worldwide on process analytics. Key competencies are the process-safe measurement of pH, ORP, conductivity and oxygen. In addition to sensors, Knick also offers innovative process analyzers, high-quality holders and fittings as well as unique cleaning and calibration systems.
Advanced technologies driven by highly complex research and development
The development of a novel active pharmaceutical ingredient typically requires large investments in time and capital to translate scientific discovery into new medicine and to build specialized manufacturing facilities and equipment, starting with the need to produce the initial supplies of an investigational compound for use in clinical trials prior to scale up to full-scale production upon FDA approval.
Nowadays it is nearly impossible to fight rare or complex diseases without therapies developed by the biopharma industry. Animal, or insect cells, bacteria, and yeast are genetically modified to produce target molecules like recombinant proteins, vaccines, and many more. Their manufacturing is a complex process due to the heterogeneity of the living organisms. Heterogeneity in the upstream process (USP) transfers to the subsequent product purification steps in downstream processes (DSP), too.
Automation throughout the upstream, downstream, and auxiliary processes helps to reduce the risks of human errors, improves operational efficiency, and thus increases the safety and quality of the final product.
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Why Knick ?
As a specialist for measurement and control technology, Knick offers a high level of expertise and application knowledge in the field of liquid analysis in complex applications. The in-house vertical range of manufacturing ensures product quality and flexibility with regard to customer-specific requirements.
Customer proximity and reliability characterize the company just as much as its innovative products and technologies, which are used today globally by well-known manufacturers in the chemical and pharmaceutical sectors.
Biopharmaceutical Pathway: Solutions for every process step
Every process step of the biopharmaceutical pathway is important and requires specific measurement technology to control the critical process parameters for maximized yield, and reduced process deviations.
Knick offers complete measurement loops from sensors to fully automatic sensor maintenance systems. Automated processes help to maximize standardization, avoid transcription errors, and increase compliance.
With the Knick cCare Pharma system major goals of FDA’s PAT initiative are addressed:
- Standardization of calibration and cleaning processes for less variations, and deviations
- No more transcription errors leading to lessbatches lost
- Audit trail ensures compliance with the regulations.
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BioPharma Industry Brochure
Overview of specific applications and product solutions in various fields of BioPharma.
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