Insights from industry

The Benefits of QbD and PAT Frameworks

AZoM talks to Dr. Myke Scoggins about the MAS and MPS lab within Micromeritics and how they can assist with Process Analytical Technology and QbD.

Could you please provide a brief introduction to Micromeritics and specifically the MAS and MPS divisions?

Micromeritics, in business for over 50 years, was the first company to market commercially automated surface area, mercury penetration, and sedimentation particle size analyzers. Micromeritics is world-renowned for its pioneering innovations in these areas and others, including porosimetry, density, zeta potential, and chemisorption analysis.

The company has also led the way in the areas of liquid chromatography, density, automatic sample delivery, TPD/TPR chemisorption, balanced adsorption surface area, and DFT Plus® (NLDFT) data interpretation. The company has been granted over forty patents in these combined areas of materials characterization.

Micromeritics Analytical Services (MAS) and Micromeritics Pharmaceutical Services (MPS) is a contract service laboratory within Micromeritics. Our DEA-registered laboratories include all of the Micromeritics-manufactured instruments, instruments from our Particulate Systems line, and other speciality instruments that add to our ensemble of characterization techniques that add value and provide solutions for the pharmaceutical industry.

With analysts experienced in the techniques, industry-leading turnaround times, and a customer service philosophy that makes each of our customer’s unique needs our top priority, we can provide you the data you need ranging from a single analysis to complex method development and method validation projects in a cGMP environment.

Could you outline what is meant by Process Analytical Technology (PAT)?

As described in the FDA Guidance for Industry document on PAT, it is the scientific, risk-based framework intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance.

This framework is founded on process understanding to facilitate innovation and risk-based regulatory decisions by industry and the FDA. The framework has two components:

  1. a set of scientific principles and tools supporting innovation
  2. a strategy for regulatory implementation that will accommodate innovation.

How can MPS help companies implement this?

As described in above, PAT involves a set of tools to support innovation. MPS has, at our disposal, a large number of instruments that can be used to either provide a specific measurement from a specific type of analysis or we can provide data from multiple types of analyses to give more of an overall solutions package that can be predictive of the performance of a particular excipient, API, process intermediate, or final dosage form.

Further to this, could you explain the ‘Quality by Design (QbD)’ approach?

As defined in ICH Q8, Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. This approach includes developing a design space through use of design of experiments, creating a Quality Target Product Profile (QTPP), and identifying Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).

In addition, QbD encompasses risk management approaches that identify and evaluate risks and allows for organization of information to support risk decisions in conjunction with quality systems, as outlined in ICH Q9.

How does this aid the drug development process?

These approaches allow for more regulatory flexibility, in that a company can operate within proven acceptable ranges of processing parameters which will produce a quality product able to perform as intended in the patient.

This gives a certain amount of freedom not previously available to make certain process changes without additional and often costly regulatory filings.

How is a QbD framework traditionally utilised within material sciences?

QbD is a more recent development in the pharmaceutical industry. Prior to QbD, development of new products didn’t necessarily follow a consistent path from company to company. Now that there is a roadmap to development, companies are becoming more familiar with FDA expectations, particularly when it comes to material science.

With the expectation that companies will fully characterize raw materials as well as process intermediates and finished dosage forms, Micromeritics Pharmaceutical Services is in the unique position to offer physical characterization services that provide the needed and important information necessary to provide a wide array of these characterization techniques that will be included in the Common Technical Document.

Do you feel this use has changed or increased recently?

With publication of the ICH Q8, Q9, and Q10 documents governing QbD in pharmaceutical development, risk management, and quality systems, expectations are becoming clearer.

Although many companies may still be struggling with how to implement these guidelines, it is clear that these approaches are being utilized with increasing frequency.

What techniques does Micromeritics use for particle analysis?

At Micromeritics Pharmaceutical Services, we offer material characterization services such as particle size analysis, surface area, density, porosity, zeta potential, moisture sorption, and thermal analysis. Many of these tests are non-destructive, allowing for testing of multiple characteristics with small amounts of material, which can be beneficial when, for example, small amounts of newly developed APIs are available.

This testing can also be performed on process intermediates such as roller compacted ribbons or granules from a wet granulation process or final dosage forms such as tablets or lyophilized cakes. The amount of data we can generate can truly provide our customers with added value using a material-sparing ensemble of techniques that provide useful solutions from drug development through regulatory filings and beyond.

How can a QbD framework mitigate against manufacturing failures?

Through material characterization and in-process monitoring at points of processing identified by a company’s risk assessment program as being critical process parameters, the company is able to identify manufacturing issues further upstream, resulting in less re-work and fewer product failures that, in the past, may not have been identified until the quality control process, long after a detrimental event occurred.

Now that these events can be detected earlier in the process, companies are able to save time and money by taking corrective and remedial action before a process spins out of control and results in unacceptable product.

How do you see PAT and QbD being utilised in the future?

I feel that adoption of these tools and systems will take hold as more companies become more familiar and comfortable with expectations of the regulatory bodies. Additionally, the regulatory agencies will also need to gain a comfort level and familiarity with these new expectations and how they are applied across the board.

There will always be special cases and the need for unique interpretations, but with a roadmap being developed, it’s my hope that a common destination will be in everyone’s sights.

About Dr. Myke Scoggins

Dr. Myke Scoggins

Dr. Myke Scoggins earned his BS in Microbiology from the University of Georgia and a PhD in Pharmaceutical Sciences from Mercer University. He has over 20 years of experience in the pharmaceutical industry including analytical chemistry, preformulation, formulation, process development and validation, scale-up, tech transfer, and manufacturing support. Prior to joining Micromeritics, Dr. Scoggins worked with a medical device company managing microbial and chemical testing as well as sterilization validations.

He has worked at generic pharmaceutical companies, larger international companies, and a research university (Georgia Institute of Technology). He has given numerous lectures on topics in the pharmaceutical sciences to PhD students, helped develop graduate courses in pharmaceutical sciences at local universities, and presented research findings at national meetings.

Dr. Scoggins is currently a member of AAPS, ASQ, AAMI, and AOAC. He currently serves as Pharmaceutical Scientist and Lab Manager for Micromeritics Analytical Services and Micromeritics Pharmaceutical Services.

Disclaimer: The views expressed here are those of the interviewee and do not necessarily represent the views of Limited (T/A) AZoNetwork, the owner and operator of this website. This disclaimer forms part of the Terms and Conditions of use of this website.

G.P. Thomas

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G.P. Thomas

Gary graduated from the University of Manchester with a first-class honours degree in Geochemistry and a Masters in Earth Sciences. After working in the Australian mining industry, Gary decided to hang up his geology boots and turn his hand to writing. When he isn't developing topical and informative content, Gary can usually be found playing his beloved guitar, or watching Aston Villa FC snatch defeat from the jaws of victory.


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