Adopting Manufacturing Innovation to Improve Quality and Accelerate Time to Market

The Role of Advanced Manufacturing, In-Process Sampling and Process Models

The pharmaceutical industry’s pursuit of excellence hinges on its ability to deliver safe, effective and high-quality drug products. A recurring theme from industry executives is the push for greater efficiency, which continues to reinforce the need to adopt technologies like in-process sampling, advanced manufacturing and process models to bolster the supply chain, improve quality and accelerate time to market.

The Impact on Technology Providers and the Industry

Advanced manufacturing technologies are tools for enhancing the quality and availability of drug products as the industry considers how to modernize pharmaceutical processes. Current CGMP regulations offer manufacturers flexibility to adopt more efficient and innovative methods that meet compliance standards and improve patient outcomes. The insights gained from more robust product and process development help establish effective control strategies throughout the product lifecycle, ensuring drugs maintain critical quality attributes. Additionally, modern technologies enable in-line, at-line or on-line testing, reducing the need for physical sample removal and further supporting process efficiency and accuracy. By adopting these advancements, efficiencies are improved, and the risk of error is reduced, benefiting both patients and the industry.

Paving the way for Excellence in Pharmaceutical Manufacturing

Technology Advances	Advanced manufacturing technologies such as continuous manufacturing, process analytical technology (PAT), process modeling and updated statistical tools which have continued to evolve over the past few decades. These technologies have an integral role in fostering continuous improvement and industry best practices, with advocacy in their adoption from many industry organizations including the International Council for Harmonization (ICH).
Maintaining Drug Quality	As pharmaceutical companies adopt more sophisticated manufacturing techniques, guidance needs to ensure that companies are bringing in new processes without compromising product integrity.
In-process Monitoring	In-process sampling, testing and real-time monitoring are critical components of modern manufacturing and emphasize the need for proactive quality control measures. These practices ensure that quality is built into the product at every stage of production, rather than being tested solely in the final product.
Integration of Process Models	Predictive models use historical data to simulate and optimize manufacturing processes and control strategies, providing valuable insights that can enhance product quality and process efficiency.
Risk-Based Approach	The ICH Q9 (Quality Risk Management) has been encouraging companies to adopt more robust, risk-based approaches to process monitoring and control for the pharmaceutical industry. This includes identifying key control points and focusing on preventing errors early in the process rather than relying on final product testing alone. The ICH guidelines also reinforce the FDA’s Computer Software Assurance (CSA) draft guidance.
Global Harmonization	This is particularly relevant as pharmaceutical companies operate globally because harmonized standards facilitate compliance and easier regulatory approval across regions. Updates to FDA regulations often align with international standards set by bodies like the ICH.

FDA Wants to Hear from You

To encourage the adoption of In-Process Sampling and Testing, Advanced Manufacturing and Process Models, FDA recently issued the draft guidance, Considerations for Complying with 21 CFR 211.110. The guidance offers valuable direction for manufacturers as they strive to embrace advanced manufacturing techniques without compromising quality standards. FDA is seeking industry input on this guidance for 21 CFR 211.110 with public comments due by April 7, 2025.

In Brief

Axendia’s team has long advocated for the adoption of advanced manufacturing and process modeling and simulation, however, we continue to see a lag in their adoption, despite demonstrated evidence of improved quality and time to market. In-process sampling, testing and the use of advanced technologies creates significant opportunities for technology providers supporting the pharmaceutical industry with sensors, software and automation solutions. In addition, pharma companies’ ambitions of end-to-end digitalization and the flexibility it brings will drive demand for data integration platforms, with Internet of Things (IoT) also playing a critical role.

Given that cultural inertia continues to be a challenge to enterprise-wide adoption of advanced technologies, software and instrumentation providers need to reassess their design and delivery of solutions to ensure barriers to entry are minimized for their customers.

Schedule an Analyst Inquiry with Axendia to discuss the opportunities the FDA’s position on In-Process Sampling, Advanced Manufacturing and Process Models presents for your organization and what you can do about it.

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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

The Role of Advanced Manufacturing, In-Process Sampling and Process Models

The Impact on Technology Providers and the Industry

Technology Advances

Maintaining Drug Quality

In-process Monitoring

Integration of Process Models

Risk-Based Approach

Global Harmonization

FDA Wants to Hear from You

In Brief