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With our Werum PAS-X MES - on premise or cloud-based - and our software solutions for analysis, track & trace, networked factories, and intelligent packaging, we are the world's leading supplier and partner to the pharmaceutical and biotech industries.

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We are specialists for complete handling systems for pharmaceutical and medical products. Our solutions are decisive in the field of contactless and safe transport of e.g. glass syringes.

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As the world's leading inspection expert, we develop solutions for the pharmaceutical and biotech industries. Our range of products extends from high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control.

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We are a leading supplier of packaging machines for liquid and solid pharmaceutical and medical products. With our blister, sachet and stick packaging machines we offer solutions for primary packaging. Our side and topload cartoners set standards worldwide for secondary packaging.

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K.Pak Topload Case Packer

Introducing our latest solution from Körber; the K.Pak Topload Case Packer! Created specifically for the pharmaceutical industry, the K.Pak solution provides operator-friendly machines to complete any production line. Our solution focuses on innovative technology, high-quality design and expert handling and packaging of your product. It’s time to start connecting the dots with Körber!

Packaging solutions

Packaging solutions

As long-standing specialists, we develop packaging solutions for innovative and high-quality secondary pharmaceutical packaging made of cardboard. We offer you solutions for counterfeit protection, standard folding boxes and much more.

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Our experts will advise you during the analysis of your requirements, show you optimisation potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry.

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Thomas Zahel


Successful process characterization in biotech: A how-to-guide in 7 steps

Process validation (PV) aims at reassuring a manufacturer of constant product quality. It is also a regulatory requirement to achieve licensure of a pharmaceutical product. Failing to efficiently plan and execute activities on that stage leads to increased time-to-market. 

The fact that in the 22 pages of the latest FDA guidance document on process validation, statistical approaches and the need of statisticians in a multi-disciplinary team is mentioned no less but 15 times underscores the importance of showing statistical confidence about the chosen control strategy for critical process parameters (CPPs), input material and measured critical quality attributes (CQAs) during the manufacturing process (ICH Q8 (R2) 2009, 8). 

Figure 1: The aim of process validation is to identify the impact of process parameters of individual unit operations on the final drug substance product quality.

Every process characterization (PC) strategy aims to identify process parameters that impact product quality and yield:

  • Identify interactions between process parameters and critical quality attributes
  • Justify and if necessary adjust manufacturing operating ranges and acceptance criteria
  • Ensure that the process delivers a product with reproducible yields and purity

Successful PC is achieved when:

  • Scope, deliverables and timelines are well aligned between all stakeholders
  • Evidence-based decision making is increased and influence of the loudest voice during risk assessments is reduced
  • Equivalence testing is employed to identify potential offsets between scales
  • Impact of PPs onto CQAs is identified at minimal experimental effort
  • A model-based control strategy (e.g. PAR) is established for each unit operation
  • A holistic control strategy, taking the mutual interplay of all unit operations into account, is achieved using integrated process modelling. This shows that the manufacturing process is well understood and consistently delivers highest product quality in drug substance (DS) in the future.

In the following we show you how to successfully conduct a process characterization study (PCS) in 7 steps:

Figure 2: Tasks and typical timeline of a process characterization study

1. Achieve project transparency with a Process Validation Master Plan 

You should start with a plan comprising all intended steps and goals. Data collection and evaluation need to be aligned as usually many internal stakeholders (process development, manufacturing, and manufacturing science departments) and external like CRO & CMO are involved. Transparent information about timelines, data flows, interfaces to departments/ stakeholders and deliverables guarantee timely delivery of the final PCS report and allows to include it into BLA filing.

With PAS-X CMC Consulting, Körber supports in the development of requirements for each task and herein delivers a detailed timeline that ensures timely delivery of regulatory documents and finish process characterization studies.


2. Avoid unpleasant side effects and conduct a risk assessment

The aim of a Failure Mode and Effects Analysis (FMEA) is to pre-select potential impacting factors for further experimental investigation and rate other factors as being not critical based on process expertise. It is very important to incorporate data-based prior information of occurrences and severities. By that, you reduce the impact of individual opinions on the final FMEA outcome. 

Our PAS-X CMC Consulting experts assist in regulatory compliant qualitative and quantitative risk analysis according to ICH Q9.