Biopharmaceutical product development is burgeoning with developments in treatment approaches, chemistries, and vectors giving companies new strategies for targeting disease. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). Many other products are also under development with innovative designs in the areas of fusion proteins, antibody drug conjugates (ADCs) and related species, peptides, and oligonucleotides.

No matter the nature of the product under development, one of the single most important factors during that development phase is the analytical characterization of the product. The need to characterize goes beyond the obvious requirement for demonstration of correct structure of the API itself but also demonstrates control of the manufacturing process, assesses impurity profiles, and ultimately feeds back to changes and improvements in the manufacturing process to ensure the best quality product. Characterization data also builds in quality to the product by having that deep knowledge of its structure and compositional profile. A detailed and thorough characterization is required to be presented to regulatory authorities as part of any submission for regulatory approval and marketing authorization.

The expectations for structural analysis are clearly laid out in a guideline published a number of years ago by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q6B provides a clear framework for expectations regarding the structural characterization of biopharmaceutical products (2). While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. It uses terms like “to the extent possible”, thus allowing for methodological developments pushing the ability to detect structural details in ever greater and more precise ways. That being said, it is recognized that an update is due to acknowledge and bring into focus current analytical practices and to align it with other ICH guidelines. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals. This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). So why is ICH Q6B so important, and what does it outline?

Biopharmaceuticals, which are produced either in cellular systems or created through chemical synthesis, are molecules with incredible complexity. They can be orders of magnitude larger than what we may consider basic pharmaceuticals to be and with this increased size comes not only increased complexity but increased ways in which this complexity manifests. One must consider not only the basic linear structure of the molecule but also the three-dimensional (3D) shape, modifications (either wanted or unwanted) that occur on the molecule, and interactions that may occur within and between molecules themselves (e.g., disulfide bridges and aggregation). Also, consideration must be given to impurities that may arise as a result of the manufacturing or purification processes. All these must be investigated to give as a full a structural characterization of the product as possible and also to use the data as a tool to hone the manufacturing process itself to produce the best quality drug possible. ICH Q6B details the aspects of molecular structure for which characterization is expected.

Firstly, and perhaps most importantly, ICH Q6B requires that the primary amino acid sequence of the product (protein or polypeptide) is determined. This is crucial because a recombinant protein or synthesized peptide must have a known and specific amino acid sequence to fulfill its function. No precise methodology is given for how this should be performed, but modern methods of sequencing rely heavily on state-of-the-art mass spectrometry to provide the most complete and accurate data. Depending on the instrument type, mass spectrometers (e.g., quadrupole time-of-flight [Q-TOF] geometry and similar instruments) can generate mass values with very high mass accuracy (low ppm). This high mass accuracy in combination with this type of instruments’ ability to fragment peptides generates precise sequence information.

Proteins are proteolytically digested to peptides using strategies tailored to the protein under investigation. Peptides are separated and analyzed by on-line liquid chromatography–mass spectrometry (LC-MS), and fragmentation data generated are then used to determine peptide and ultimately protein sequence. This is not to say that MS will be able to generate 100% of the sequence coverage. There may be regions of the protein where peptide generation is difficult or fragment ions are weak or ambiguous. In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling.

ICH Q6B also requires that the overall amino acid composition of the product is investigated. To achieve this, the relative molar amounts of each amino acid in the product need to be determined. This is typically carried out using relative quantitation of amino acids following acid hydrolysis of the product and chromatographic separation of the released and derivatized amino acids. Comparison to known amounts of standard amino acids allows for accurate quantitation of each amino acid. It is recognized that no single acid hydrolysis condition will be suitable for all amino acids, so this must be taken into account in terms of recoveries of amino acids and if necessary alternate hydrolytic approaches taken.

Both the N- and C-termini of the product are required to be assessed to demonstrate the degree of homogeneity in each case. Post-translational processing may result in changes to the termini (e.g., ragged ends or N-terminal pyroglutamination), and these must be investigated. N-terminal analysis can be performed by gas phase sequencing if there is a free amine group at the N-terminus (e.g., no pyroglutamination or other blocking group), but there is no equivalent analysis for the C-terminus. Therefore, these terminal investigations are often performed as part of the peptide mapping study.

Peptide mapping is one of the most data-rich analyses that ICH Q6B requires. This investigation is, in some ways, associated with the procedure for primary amino acid sequencing discussed previously. However, peptide mapping focuses on mass analysis of proteolytically released peptides and comparison to the expected masses. The use of high-end mass spectrometers that can generate real-time fragmentation data allows a further confirmation of the identity of peptides detected. Peptide mapping generates a wealth of data, because the combination of specific proteolytic digest and on-line LC-MS analysis of the digest products allows not only accurate mass identification of the peptides themselves but also the identification of any post translational modifications (

). These may either be specific to the production process itself (such as pyroglutamination of the N-terminus as is frequently seen in monoclonal antibodies (mAbs) or may be the result of purification processes (such as amino acid oxidation or deamidation events) and may indicate that process change is required. Peptide mapping also generates data that are required for other areas of ICH Q6B, specifically terminal amino acid sequence identification and disulfide bridge analysis. It also identifies glycosylation sites and can be used to assess the degree of glycosylation site occupancy for glycoproteins. It thus fits well into a multi-attribute monitoring workflow.

Disulfide bridges are links formed across a protein chain, or between protein chains, via the side chain thiol groups of the amino acid cysteine. These bridges serve to maintain the correct 3D shape of the molecule and are very precisely formed, such that the same bridges will be formed from the same pair of cysteine residues in each copy of the protein. The disulfide bridges in a protein are required to be identified to confirm that first they are present and secondly that they are correctly formed. The presence of incorrect disulfide bridges is termed “scrambling” and indicates the presence of a misfolded protein population. This population is likely to result in inactive material but could at worst lead to an immunogenic response in the patient or product aggregation. Disulfide bridges can be identified through targeted proteolytic and/or chemical digestion strategies and MS-based analyses and can be seen as akin to peptide mapping, albeit focused specifically on the bridges (

). It is also important to assess for any unbridged cysteine residues.

Many of the biopharmaceutical products on the market today are glycoproteins with mAbs being the most widespread example. For glycosylated products, it is a requirement that the sugar structures of the molecule (known collectively as glycosylation) are thoroughly characterized. This requires a quantitative analysis of the individual monosaccharides in the glycans (which can be performed by gas chromatography [GC]-MS or LC with fluorescence detection for sialic acids), but most significantly the overall glycan profile must be investigated. This usually involves release of the glycans, and either fluorescent labeling and analysis by on-line LC-MS with fluorescence detection (

) or MS analysis of released glycans following chemical derivatization, depending on the type of glycan being analyzed. This process allows the relative abundances of each glycan to be assessed along with the identification of each glycan’s composition through mass values detected.

To be able to fully define their structures, the linkages between the monosaccharides must also be characterized. Linkage analysis can be performed through a series of elegant chemical steps culminating in GC-MS analysis of the end products. The elution positions and fragmentation patterns identify the original linkage and type of each monosaccharide. Knowing the biosynthetic pathways of glycosylation along with the data generated, it is then possible to define the population of glycans on the product to the extent possible. ICH Q6B also requires that, for glycoproteins with more than one glycosylation site, the glycan profile at each site must also be characterized. Glycosylation is not a templated post-translational modification (PTM) and can be highly heterogenous, depending on the glycoprotein. A detailed knowledge of glycan biosynthesis is needed to fully interpret the data and define the glycan structures indicated by the data.

Modern MS instruments have very high mass accuracy and resolution, allowing an accurate assessment of the molecular weight of the intact product and associated heterogeneity (low ppm). It not only provides data related to the size of the molecule but also may provide orthogonal data supporting other primary assessments of key molecular characteristics including post-translational modifications. Analysis under various conditions (e.g., native [

], reduced, and/or following deglycosylation) allows for an assessment of the overall product mass as well as individual protein chains in multimeric species and protein chains in the absence of glycan heterogeneity.

The MS data should be used alongside data from more traditional methods such as sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) (or its more modern capillary-based equivalent of capillary electrophoresis-SDS) and size-exclusion chromatography (SEC) when compiling a robust characterization package, to generate orthogonal data sets. With their technical and methodological improvements, advanced techniques provide valuable information on overall product mass profiles. With properly designed experiments, these analyses provide data that will be indicative of the quality of the manufacturing process and the product itself.

Charge isoform analysis provides a profile of species within the sample based on separation of the various charge states. There are many structural attributes within a protein that can affect the charge profile, the most frequently encountered being the post-translational modification deamidation, the presence of sialic acid in glycoproteins, or in the case of monoclonal antibodies (mAbs) the presence of pyroglutamate or heavy chain C-terminal lysine.

ICH Q6B notes the isoform pattern can be assessed using isoelectric focusing or other appropriate techniques. Frequently the capillary-based technique of image capillary isoelectric focusing (icIEF) is used due to its speed, resolution, reproducibility, and reliability of UV and fluorescence-based detection for relative quantitation. Data generated gives charge profile information, which can be further investigated using specific sample treatments prior to reanalysis. This is another area where collection of orthogonal data builds a thorough understanding of the product. For example, charge-based PTMs detected during peptide mapping or glycan analysis experiments may give rise to unique isoform profiles. Along with isoelectric focusing, ion-exchange chromatography can be used to assess isoforms as well as chromatographic patterns.

It is vital to be sure of the amount of product being administered to ensure patient safety and for product bioassay data generation. A common UV absorption reading can be used to measure protein content. When this strategy is applied, it is critical to determine the extinction coefficient. This determination can be achieved using a combination of ultraviolet-visible spectroscopy spectrophotometry and optimized amino acid analysis that has been assessed specifically on the product to demonstrate its suitability. Very often this encompasses a qualification or validation of the method to ICH Q2(R2) specifications (5,6).

Some aspects of structural characterization requirements specified by ICH Q6B overlap with one another. In the case of electrophoretic patterns for example, the same icIEF and CE-SDS experiments applied under the headings of size and/or isoform patterns can be used to provide the required data on identity, homogeneity, and purity for the characterization dossier that this analytical section covers.

The identity, homogeneity, and purity of biologic products needs to be evaluated, and this can be carried out using a variety of chromatographic techniques. The most commonly employed are reverse-phase, SEC, and ion exchange chromatography, each evaluating a different physicochemical characteristic of the molecule. As with other characterization assays, additional or substitute methods such as HIC or HILIC (hydrophilic interaction chromatography), can be used to enhance knowledge and understanding of the product depending on its structural characteristics. Several chromatographic techniques are expected to be applied to separate out components based on different physical properties such as charge, hydrophobicity, and mass. This gives the most comprehensive investigation into the overall composition of the sample because any coeluting species in one technique will likely separate in others.

Spectroscopic techniques are applied during characterization to assess the higher order (secondary and tertiary) structure. The 3D shape of a biological product plays a critical role in its function and therefore must be characterized to the extent possible. The higher order structures of molecules can be composed of different types of structural features, depending on the nature of the primary amino acid sequence and how it interacts with itself in its solution environment to produce the final 3D shape. At the secondary structural level, ordered structural features such as alpha helices or beta sheet structures can be produced, depending on the amino acid sequence, but regions of more random-type structure can also be found. How these secondary structural units interact with one another and assemble in three dimensions gives rise to the tertiary level of molecular structure. Various techniques should be applied during characterization, each of which has its own relative strengths and will thus probe the structure in different and orthogonal ways. The techniques of circular dichroism (CD), Fourier transform infrared spectroscopy (FT-IR), fluorescence analysis, microfluidic modulation spectroscopy (MMS) and nuclear magnetic resonance (NMR, both 1D and 2D) are all appropriate for higher order structural (HOS) analysis and provide a meaningful orthogonal dataset (7).

An assessment of aggregation is important as part of an investigation into product related impurities, which is also covered by ICH Q6B. Orthogonality is again important here and the application of two techniques such as SEC-multi-angle light scattering (MALS) (a column-based method, 

) and SV-AUC (a non-column-based method), which work on different physical principles, gives meaningful data.

The ICH Q6B guidance document has been adopted by regulatory agencies due to its comprehensive coverage of structural requirements both for the product itself but also for impurities found within it. These in-depth characterization studies must be performed during product development and following significant process changes and are expected to be present in any drug application document.

The nature of biologically produced biopharmaceuticals inevitably results in some level of heterogeneity that must be assessed and for which techniques must be used that can provide clear and detailed analytical data. Researchers who follow the suggested guidelines outlined in ICH Q6B, using state-of-the-art analytical equipment and techniques, will be well-positioned to move their product through the regulatory processes and also for critically assessing the production process itself.

Mordor Intelligence. Biosimilars Market Size | Industry Growth & Forecast Report. Mordorintelligence.com (accessed May 5, 2025).

ICH. Specifications. Q6B. Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH, March 1999).

FDA. Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations, Draft Guidance for Industry (CDER, CBER, 2019).

EMA. Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substances: Quality Issues (revision 1) (May 22, 2014).

ICH. Q2(R2). Analytical Validation (ICH, 2023).

Easton, R.L. Structural Characterization Methods for Biosimilars: Fit-for-Purpose, Qualified, or Validated. GaBI J., 2022 11, 41-44

Greer, F and Easton, R.L. Biosimilars–Increasing Regulatory Focus on Orthogonal Analytical Characterization. International Biopharmaceutical Industry, 2021 4, 10-13.

Richard Easton, PhD, is Technical Director–Structural Analysis, BioPharmaSpec Ltd, and Christopher Ziegenfuss is Vice President, at BioPharmaSpec, Inc.

®
Volume 49, No. 5
June 2025
Page: 22–28

When referring to this article, please cite it as Easton, R. and Ziengenfuss, R. ICH Q6B for Analytics. Pharmaceutical Technology 2025 49 (5).

Articles

Analytics

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products. 

ICH Q6B for Analytics

The role of contract development and manufacturing organizations (CDMOs) is at an inflection point at the midpoint of the 2020s, mainly taking into account the impacts of two seismic factors: geopolitical shifts, driven in large part by the tariffs enacted in the first several months of United States President Donald Trump’s second term, and the seemingly omnipresent prevalence of artificial intelligence (AI).

The versatility provided by CDMOs is, by necessity, changing with the times. At the Drug, Chemical & Associated Technologies Association (DCAT) Week 2025, India-based Shilpa Medicare said it was launching a newly formed, full-service, “hybrid” CDMO aiming to serve both small- and large-molecule customers in addition to peptides, with a therapeutic specialization in oncology (1,2). Shilpa said the hybrid model would adopt a dual approach: offering comprehensive discovery, clinical, and commercial outsourcing services, but also including commercially ready, “off-the-shelf” novel formulations for business-to-business licensing.

In April 2025, a new CDMO, Meribel Pharma Solutions, was announced to be headquartered in the United Kingdom (3,4). The creation of this mid-sized CDMO was made possible by an acquisition of Synerlab Group, another CDMO, combined with the securing of seven manufacturing sites in Europe formerly belonging to Recipharm. The new company offers 10 manufacturing sites and three drug development services sites in France, Spain, and Sweden, and has established centers of excellence in drug development, lyophilization, preservative-free multidose technologies, and flexible stick-pack and sachet production, meant to support both human and veterinary health products while operating under stringent global regulatory certifications.

One initiative that had been announced prior to the start of 2025 was Thermo Fisher Scientific’s Accelerator Drug Development service, described at the time of its October 2024 launch as the company’s 360° CDMO and contract research organization (CRO) drug development solutions (5). In January 2025, Lyndra Therapeutics, of Watertown, Mass., announced a strategic collaboration with Thermo Fisher leveraging the Accelerator Drug Development platform and allowing Lyndra to use Thermo Fisher’s end-to-end, advanced pharmaceutical manufacturing capabilities based out of Cincinnati, Ohio, to manufacture commercial materials at scale (6,7).

This partnership is indicative of a current trend toward custom, specialized relationships based on specific needs—in this case, Lyndra’s long-acting oral therapies including its lead investigational product, oral weekly risperdone (LYN-005)—rather than a more generalized shared-services approach. Even with that, or perhaps because of it, new concepts like the “hybrid” CDMO are emerging with more frequency. And the presence of artificial intelligence (AI) and a push for smart and/or automated technologies to pick up more and more of the work are all contributing to the shifting landscape.

®’s Drug Digest video series, Adi Kaushal, director and Technology Head of Bioavailability Enhancement at Lonza, discussed the growing preference in the market for oral solid dosage (OSD) forms, like Lyndra’s candidate, and how CDMOs can leverage their experience in performing much-sought-after expert techniques to improve OSD bioavailability to meet demand.

“CDMOs like Lonza are important partners for the smaller biotechs and emerging biotechs, and that is really driven by the experience and the expertise that CDMOs bring to the table, especially for smaller companies that may not have that experience in that space,” Kaushal said (8). “Alongside that, what comes into the picture is investment into state-of-the-art facilities and equipment, which is essential for the manufacture of a lot of these drug products. And then the final part is the regulatory knowledge and the technical knowledge that the CDMOs bring to the drug development process, partnering with the smaller biotechs. That’s really important, because the regulatory landscape is ever-changing, and it is often inherently linked to the technology in question. And so that technology expertise and regulatory expertise, from a regulatory standpoint or compliance standpoint, [are] critical to the progression of molecules into real therapies, and commercializing those.”

What these myriad areas of expertise can potentially result in, according to Kaushal, is a watertight, seamless partnership at any point of the drug product lifecycle that is desired.

“For the smaller biotechs and emerging biotechs, it’s important to partner with CDMOs such as Lonza that can work all along the value chain and can provide an end-to-end offering,” he said (8). “That’s really the key that we have seen in terms of preserving the knowledge, or building on the momentum, that you develop early on in the drug development process and then, keeping that knowledge all the way to be able to commercialize.”

®’s coverage of CPHI Americas, held in Philadelphia from May 20–22, 2025, Christy Eatmon, global subject matter expert for Sterile Drug Products at Thermo Fisher, talked about the progress made in the company’s Accelerator Drug Development offering since the fall 2024 launch, but also offered her perspective on the role of CDMOs in the industry in general.

It’s not just about partnerships between companies, Eatmon said. The connection goes further and deeper.

“I think in the past, CDMOs functioned as ‘just the hands,’ just a manufacturing house. Now we really want to partner with our customers,” she said (9).

And, she added, if those customers are using AI, companies should logically be keeping up.

“We want to be the trusted partner, the team that’s bringing innovation to the market. We have added some aspects of AI to our processes,” Eatmon said. “One of those to know, especially on the drug product side, is that we’ve integrated AI-assisted inspection. This is for large-scale commercial programs right now, but basically, we have a module where we’ve been able to decrease rejects, improving our yields, and then also using very expedited, very fast automated visual inspection—as every serial product, every unit, needs to be inspected, either by person, manually, or automated by a system of cameras.”

One usually thinks of AI as improving efficiency, but contrary to what examples from some platforms in everyday life have shown, in pharmaceutical operations, Eatmon said AI can be a boost to accuracy as well.

“This AI can actually make a huge library of potential defects and can actually go through those defects very quickly, to predict whether something the camera sees that may or may not be a defect is truly a defect,” she said (9). “We’re [also] using AI in other ways, like predictive modeling, which we’ve used for solid dose in the past. Now we’re looking to implement that for sterile products as well, to predict shelf life and things like that. So, I know pharmaceuticals [are] not always cutting-edge with things like AI, but we’re trying to implement where possible.”

The Shilpa Medicare example of a “hybrid” CDMO was just one instance of how companies are redefining not only their partnerships with each other, but also their definitions of what they themselves offer. In 

 eBook, John Tomtishen, senior vice president and general manager of the IDMO business at Cellares, discussed the industry’s long-awaited incorporation of Industry 4.0 concepts, including the novel model appearing in his job title: the IDMO, or integrated development and manufacturing organization (10).

“As the name implies, this includes fully integrated smart manufacturing facilities for true end-to-end scale,” Tomtishen said (10). “It relies on flexible manufacturing capabilities without requiring changes to hardware, meaning process modifications are entirely managed through software. As a result, technology transfer between smart facilities in any geography is streamlined through the leverage of platform standards. Combined, these aspects will make it easier to scale cell therapies globally and meet total patient demand.”

However, Tomtishen said, not just any company can call themselves an IDMO for a new spin on an old acronym. There are certain standards which must be met and maintained.

“The tenets of the IDMO concept can be viewed from the top down: manufacturing facilities must be standardized and interconnected; technology within each smart factory must ensure end-to-end integration; and the platform technologies themselves must be robust enough to serve multiple functions,” he said (10).

Cellares’ IDMO services primarily deal with easing patient accessibility to cell and gene therapies (CGTs), but the principles at the heart of the idea are universal.

“Ultimately, the promise of the IDMO is to accelerate access to life-saving cell therapies for all patients in need,” Tomtishen said (10). “Patients are not concerned about how their drug is manufactured, so long as it is safe, efficacious, affordable, and available when they need it. As such, the IDMO model is well positioned to solve the CGT bottlenecks. This will allow therapeutic developers to focus on what truly matters to their patients and not the manufacturing process, which will further drive drug development innovations across therapeutic indications.”

Whether there will be another abbreviation to come for these partner companies, perhaps working AI into the formation of letters, is a development that is yet to be seen, but one which might not be too far in the future. For now, though, outsourcing models are trending in more specified, more automated, and more customer-focused directions, keeping in mind that the pathway that gets treatments to patients with an optimal combination of safety and efficiency is the preferred path to take.

1. Lavery, P. Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025. 

, March 17, 2025.
2. Shilpa Medicare. Shilpa Launches ‘Hybrid CDMO’ at DCAT. Press Release. March 11, 2025.
3. Lavery, P. New CDMO Meribel Pharma Solutions Launches with 13 Sites in Europe. 

, April 16, 2025.
4. Meribel Pharma Solutions. Meribel Pharma Solutions Launches with Big Ambitions to Elevate Pharma Services to New Heights. Press Release. April 15, 2025.
5. Lavery, P. Thermo Fisher Launching New CDMO, CRO Services at CPHI Milan. 

, Oct. 8, 2024.
6. Lavery, P. Lyndra, Thermo Fisher to Partner on R&D for Long-Acting Oral Therapies. 

, Jan. 15, 2025.
7. Lyndra Therapeutics. Lyndra Therapeutics Announces Strategic Clinical Research and Commercial Manufacturing Services Collaboration with Thermo Fisher Scientific for Long-Acting Oral Therapies. Press Release. Jan. 15, 2025.
8. Lavery, P. Drug Digest: Patient Preference Drives Solid Dosage Trends. 

, May 22, 2025.
9. Lavery. P. CPHI Americas 2025: The Evolving Role of the CDMO. 

, May 28, 2025.
10. Tomtishen, J. Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck. 

®
Vol. 49, No. 5
June 2025
Pages: 30–32

When referring to this article, please cite it as Lavery, P. Market Demands and Emerging Technologies Shape Outsourcing Models. 

Outsourcing

Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.

Market Demands and Emerging Technologies Shape Outsourcing Models

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Q: How can the new document from the Parenteral Drug Association (PDA), PDA/ANSI Standard 06-2025, help manufacturers and laboratories improve their culture and processes?

A: PDA/ANSI Standard 06-2025 is a consolidation of guidance documents, tools, and models to assess and improve quality culture. Companies have probably seen how the state of the quality culture can impact an organization positively or negatively. This document is a great tool to research the key aspects of culture, assess the status of your culture, and create a strategy to maintain and improve the quality culture of your organization.

Q: What is a quality culture and what does the term refer to?

A: Quality culture is something seen and felt everyday as an employee and as a consumer in our everyday lives. It is hard to put into words, but it is defined well in the PDA/ANSI 06-2025 standard as “the overriding attitude, both expressed and implied, of an organization towards quality” (1).The document breaks it down into two distinct elements: a culture of shared values, beliefs, expectations, and commitment toward quality and a structural/managerial element with defined processes that enhances quality and coordinates individual efforts. It is the cross-functional ownership of quality at all levels, as well as the beliefs and systems that drive our actions each day.

Q: What factors of a quality culture are important in the pharmaceutical industry?

A: The document has so much information on the key factors of a good quality culture.The consistent themes that stand out are:

Leadership commitment—quality accountability, recognition, feedback loop, Gemba, visionary, strategic, enablers, respect your team, humility, trust

Employee engagement and ownership—mission focused, striving for excellence

Consistent standards and expectations —all sites, all teams aligned and striving for the same outcome, courage to do what is right, communicate the behaviors that you expect

Collaboration and communication—together, sharing, learning from each other, planning

Technical excellence—which was a newer way to group concepts that companies are familiar with, such as mature systems, competence, organizational learning, technology/innovation, and agility.

Q: Can you talk about the application of these factors in a laboratory setting and how it may differ from that of a manufacturer?

A: All of the above attributes apply and are critical for a laboratory’s quality culture, but in the authors’ opinion, some items are even more critical for a testing laboratory to succeed.In a laboratory, the main resource is people, not machines or facilities. Scientific competence and a good understanding of why things are done a certain way is paramount to producing quality results and solving problems for customers. Good leadership and employee engagement can make a huge impact on quality culture and the results achieved for clients.

Q: To what extent is the customer perspective incorporated into quality decision making?

A: The customer perspective must be embedded in strategic planning, quality systems, and day-to-day activities. The customers’ product end-users, along with their regulators, determine what good quality looks like in any particular setting. If contractors are not viewing their work through their clients’ eyes, they will miss the mark on quality. Aligning employees’ responsibilities with customers’ expectations, particularly in the pharmaceutical industry, creates employee engagement as they get excited about what customers are doing. This also creates partnerships with customers that are based on achieving mutual success. What customer doesn’t want to be understood by the provider to whom they are going for a solution?

PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

When referring to this article, please cite it as Cushing, M. and Schniepp, S.J. Guidance on Quality Culture Standards. 

Ask the Expert

Guidance on Quality Culture Standards

Progress in biopharmaceutical science is happening at a pace that challenges even the most seasoned professionals to keep up. This issue of Pharmaceutical Technology® brings that momentum into sharp focus, offering readers a roadmap through scientific breakthroughs, operational innovation, and the cultural shifts required to deliver tomorrow’s medicines.

Our cover story, “Advancements in Biopharma Spur Industry-Wide Innovation,” looks at how messenger RNA platforms, cell and gene therapy pipelines, multispecific antibodies, and extracellular vesicle therapeutics are reshaping the commercial landscape. Thought leaders predict a future in which no single modality dominates; instead, diverse targeted options will coexist, forcing manufacturing and regulatory models to evolve quickly.

Building on that science, the Development feature, “Achieving Targeted Delivery with Nanoscale Systems,” details how lipid, polymeric, and biomimetic nanocarriers are boosting bioavailability and enabling combination therapies.

Downstream on the factory floor, our Manufacturing Q&A with ACG Packaging Materials’ Sheikh Akbar Ali, PhD, illustrates how digital printing techniques, solvent-free adhesives, and advancements in single-use packaging are helping manufacturers meet productivity goals and prioritize sustainability.

As always, quality and compliance remain front and center. Our Pharma Fundamentals feature, “ICH Q6B for Analytics” translates the quarter-century-old guideline into today’s high-resolution mass spectrometry workflows, clarifying expectations for primary sequence confirmation, glycan profiling, and disulfide mapping. Meanwhile, the Outsourcing feature delves into how artificial intelligence and “hybrid” contract and development organzanizations are redefining sponsor relationships amid geopolitical supply chain pressures.

This issue’s Ask the Expert series dives into the PDA/ANSI Standard 06-2025, offering practical advice for embedding leadership accountability, employee engagement, and technical excellence into an enterprise-wide quality culture.

Together, these articles underscore a central message: success in 2025 demands not only cutting-edge science, but agile operations and a values-driven culture that keeps quality at its core.

Mike Hennessy Jr is Chairman and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Driving Advancement Through Scientific and Operational Innovation. 

From the CEO

Scientific breakthroughs, operational innovation, and cultural shifts are driving tomorrow’s medicines.

Pharmaceutical Technology June 2025

ICH Q6B for Analytics

Market Demands and Emerging Technologies Shape Outsourcing Models

Guidance on Quality Culture Standards

Driving Advancement Through Scientific and Operational Innovation