Susan Haigney

Excipients and Intended Use

 spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 3 of this series, Schoneker emphasizes that excipient manufacturers must balance market expansion with the significant data requirements and liabilities associated with different routes of administration.

New excipients are typically created with a specific target market and intended use in mind—often starting with oral applications to manage the volume of required safety and analytical data.An excipient is utilized for an application outside of this intended scope, such as moving from oral to parenteral delivery, may pose challenges.The supplier may lack the necessary safety data to support the new application or may even refuse to sell the material due to liability concerns.

Schoneker highlights that the decision to develop additional data is often an economic one; the high cost of toxicity studies must be justified by the expected sales volume. This creates a gap where pharmaceutical companies may find that no existing excipient solves a specific formulation hurdle. To bridge this gap, Schoneker advocates for collaborative negotiations. When a drug developer has a critical need for a novel excipient, they may choose to co-fund or fully sponsor the required toxicity studies.

These collaborations frequently involve exclusivity agreements, allowing the drug developer a period of sole access to the technology before the manufacturer expands the market to establish a broader regulatory precedent. Early engagement with suppliers may ensure that the available safety data aligns with the drug’s clinical objectives.

Watch the interview above to learn more about what goes into the development of a new excipient. Dave will be participating in the workshop, “Risk Based Framework for Development of New Excipient Products”, at 

 being held in Nashville from May 4-6, 2026.

Raghuram M, Sheehan C, Filler R, Schoneker D, Liu J, Gronewold C. Risk Based Framework for Development of New Excipient Products and USP’s Novel Excipient Emerging Standards Approach to Meet Stakeholder Needs. Presentation at Excipient World Conference & Expo 2026. May 4, 2026. 

https://s6.goeshow.com/ipec/annual/2026/conference_program_sessions.cfm?session_key=B7748D16-9EBD-188A-D5EE-3FF177ECEAC0&session_date=Monday,%20May%2004,%202026

Videos

In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.

PharmTech Weekly Roundup—May 1, 2026

Welcome to PharmTech’s Weekly Roundup. I’m Susan Haigney, lead editor of PharmTech.

Industry themes seen across the industry this week include the continued integration of artificial intelligence and robotics to enhance quality and efficiency, a strengthened focus on sustainability to reduce the carbon footprint of bioprocessing and evolving regulatory pathways that prioritize data trust and international alignment. From novel drug delivery devices to lean construction methodologies, these stories highlight a sector-wide push toward smarter, more resilient operations.

 s the first and only single-inhaler triple maintenance therapy for asthma in the U.S. for patients aged 12 and older. This is the product’s second approved indication since 2020.

The use of virtual control groups instead of animals in drug development was explained by Laura Lotfi of Charles River in the first episode of 

. The new approach method would help to reduce the number of animals used in the development of pharmaceuticals.

David Schoneker of Black Diamond Regulatory Consulting 

 are not approved as standalone substances but are evaluated by the FDA exclusively as part of specific drug product applications in part 2 of a multipart interview.

challenges of visual inspecting prefilled syringes

 were addressed by Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, who explained that advanced AI-native vision platforms and specialized handling technologies are now being used to overcome these unique geometric challenges.

coverage of INTERPHEX 2026 continued this week with interviews with experts on topics ranging from sustainability, bioprocessing, and automation.

George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, spoke with 

 about how manufacturers are encouraged to reassess their GMP audit strategies to address rising regulatory scrutiny regarding supplier oversight and the use of AI in documentation.

Leslie Weaver and George Hunt, IPS discussed how

early alignment of lean principles and sustainability goals in pharma construction is critical for reducing costs and absorbing schedule disruptions.

Todd Vaughn and Christa Myers of CRB explained how

implementing robotics in aseptic manufacturing improves repeatability and compliance but requires a shift toward more technically skilled operator roles.

 stressed that the large engineering, procurement, and construction management model is a tool for pharmaceutical capital projects, allowing teams to overlap design and construction phases to compress overall timelines.

adopting point-of-use cell culture media manufacturing

 can reduce the carbon footprint of bioprocessing by approximately two-thirds while providing logistical flexibility.

Successful smart manufacturing adoption depends on establishing foundational data trust and focusing on deep problem definition rather than just technical solutions, according to 

Jason Pennington and Bethany Silva of Endress+Hauser and Mel Radford of Rockwell Automation.

Stuart Tindal of Sartorius and David Chau of Thermo Fisher

 talked about how collaborative industry standards are driving the development of integrated multi-modal sensor models to enhance precision in continuous bioprocessing.

As we look ahead, the ability to balance technical innovation with rigorous regulatory compliance will define the next generation of pharmaceutical excellence. Staying informed on these shifts in construction, manufacturing, and drug development is essential for maintaining a competitive and compliant operation. Thank you for watching.

Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.

Pharma Fundamentals Episode One: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

Pharma Fundamentals Episode One: Virtual Control Groups in Drug Development

, Associate Director, Product Management, Digital Projects at Charles River

Mouse. | Image Credit: ©BillionPhotos.com -stock.adobe.com

 (EMA) issued a draft qualification opinion

 for a preclinical research methodology to reduce the use of animals in specific dose-range finding studies.

 The new approach method (NAM) would replace standard animal control groups with virtual groups, and once qualified, would allow EMA to accept evidence generated from virtual control groups in medicine approval applications.

 to limit the use of animals in drug development. In April 2025, the agency published its Roadmap to Reducing Animal Testing in to modernize drug development through human-relevant science.

 The core of the initiative is the advancement of NAMs, which include advanced in vitro systems (such as organ-on-a-chip), computational modeling, and artificial intelligence (AI). 

, the FDA draft guidance to reduce or eliminate 6-month primate studies for monoclonal antibodies. The agency also qualified its first AI-based drug development tool, AIM-NASH, and updated guidance to support a transition away from horseshoe crab-derived testing, a move that could spare over one million animals annually.

 To provide regulatory certainty, the FDA launched a searchable database documenting exactly where alternative methods are currently acceptable. Furthermore, the agency has prioritized international alignment, collaborating with global regulators to ensure these new strategies are accepted worldwide.

Virtual control groups are a NAM that can be used to support initiatives to reduce the use of animals in drug development and regulation. According to EMA, characterized control data identify appropriate virtual comparator animals to create virtual control groups that are then used to conduct testing that would be traditional performed on animals.

Laura Lotfi, associate director, Product Management, Digital Projects at Charles River, says that in addition to replacing, reducing, and refining the use of animals, virtual control groups may reduce study timelines and bring more “statistical power”. However, there are limitations to their use, including the reliability of the data.

“The data are highly dependent on the quality, the completeness of the underlying infrastructure that may contain sometimes biases or gaps that can affect the reliability of those results.

They may also be less suitable for certain scenarios,” Lotfi explains. “For example, there are some studies that involve new biological mechanism or rare endpoints, maybe some species that are not very well understood, where the limited historical data are not, quietly there yet, so there is a lack of sufficient historical data that are available. In those cases, traditional approaches may still be necessary.”

In the video above, Lotfi provides an explanation of how virtual control groups are used in drug development, their limitations, and the cost associated with their implementation.

Draft qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies. EMA. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-virtual-control-groups-vcg-replace-concurrent-control-groups-ccg-rat-non-glp-dose-range-finding-drf-studies_en.pdf

EMA consults on virtual control groups to help reduce animal use in medicines development. EMA. Press release. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development

FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. 

https://www.fda.gov/media/186092/download?attachment

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development. Press release. April 20, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development

Laura Lotfi, Associate Director, Product Management, Digital Projects at Charles River

Laura Lotfi, associate director, Product Management, Digital Projects at Charles River. Laura is a toxicologist that specializes in digital transformation within drug discovery and safety. She focuses on integrating advanced data platforms and innovative methodologies, such as virtual control groups.

Siegfried Schmitt, PhD, Vice President, Technical, Parexel

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of PharmTech’s Editorial Advisory Board.

Draft Qualification opinion for Virtual Control Groups 5 (VCG) to replace Concurrent Control Groups (CCG) in rat 6 non-GLP Dose-Range Finding (DRF) studies. 

New Approach Methodologies (NAMs). FDA.gov. Accessed April 27, 2026. 

https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams

CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs). FDA.gov, Accessed April 27, 2026. 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cderoffice-new-drugs-streamlined-nonclinical-studies-and-acceptable-new-approach-methodologies-nams

General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry, Draft Guidance

https://www.fda.gov/media/191589/download

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, Draft Guidance

https://www.fda.gov/media/189920/download

Guidance for Industry, Pyrogen and Endotoxins Testing: Questions and Answers (Edition 2)

S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals, Guidance for Industry

https://www.fda.gov/media/148475/download

Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations, Guidance for Industry

https://www.fda.gov/media/124829/download

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers, Guidance for Industry

https://www.fda.gov/media/100027/download

M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry

https://www.fda.gov/media/85885/download?attachment

FDA. Reducing Animal Testing in Nonclinical Studies Year One Progress and the Path Forward, April 2026. FDA.gov. Accessed April 27, 2026. 

https://www.fda.gov/media/191986/download?attachment

FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies


Innovative Science and Technology Approaches for New Drugs (ISTAND) Program


https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-program

Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER)


https://www.niehs.nih.gov/research/supported/translational/victer

Lotfi L, O'Neill TW, Wilcox A, Bulera S. Virtual control groups in nonclinical research: A Re-analysis of 20 studies using virtual control group data. 

https://doi.org/10.1016/j.yrtph.2026.106077

https://www.sciencedirect.com/science/article/pii/S0273230026000504?dgcid=author

Unlock Hidden Insights: Virtual Control Groups as a Data-Driven Novel Method. Webinar. 

https://www.criver.com/resources/webinar-pi-sa-unlock-hidden-insights-virtual-control-groups-data-driven-novel-method

 Z. What Lilly’s $2.75B bet on AI-discovered drug candidates means for drug development. 

https://www.pharmtech.com/view/what-lilly-s-2-75b-bet-on-ai-discovered-drug-candidates-means-for-drug-development

Thomas F. DCAT Week 2025: Quality and compliance for animal-derived products. 

https://www.pharmtech.com/view/dcat-week-2025-quality-and-compliance-for-animal-derived-products

Haigney S. USP permits use of non-animal-derived reagents for endotoxin testing. 

https://www.pharmtech.com/view/usp-permits-use-of-non-animal-derived-reagents-for-endotoxin-testing

Thomas F, Haigney S. Non-animal-derived reagents for endotoxin testing. 

https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing

Haigney S. The impact of USP Chapter <86> on endotoxin testing. 

https://www.pharmtech.com/view/the-impact-of-usp-chapter-86-on-endotoxin-testing

Focusing on the Fundamentals of Formulation


https://www.pharmtech.com/view/focusing-on-the-fundamentals-of-formulation

https://www.pharmtech.com/view/ich-q6b-for-analytics

Design Quality in Pharmaceutical Design: A Primer for Facility Executives


https://www.pharmtech.com/view/design-quality-in-pharmaceutical-design-a-primer-for-facility-executives

 Pharma Fundamentals video series. Episodes in this educational series aim to provide knowledge in the basics needed for pharmaceutical development and manufacturing, such as chemistry and pharmacology, breaking things down to the basics to help those working in the industry to better perform their jobs. Be sure to check the episode webpage for more topic information and resources. We hope you enjoy the series.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

Pharma Fundamentals: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

Regulatory Involvement in Excipient Development

 spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 2 of this series, Schoneker talks about the distinction between market volume and technical necessity: while more new excipient products target small-molecule drugs due to their market prevalence, large-molecule therapeutics may require truly novel excipients to achieve commercial viability. These innovations are often the result of collaborative development between excipient manufacturers and pharmaceutical companies aimed at solving specific formulation challenges, improving productivity, or reducing costs.

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient. 

From a regulatory perspective, Schoneker clarifies that regulatory bodies like the FDA are generally not involved in the development process unless there is a significant public health imperative, such as the development of lipid nanoparticles for COVID-19 vaccines or the transition to environmentally friendly inhaler propellants. According to Schoneker,the FDA does not approve excipients in isolation. Unlike the petition process for food additives, pharmaceutical excipients are only evaluated and authorized as part of a specific drug product application. Therefore, the Inactive Ingredient Database (IID)

 should not be interpreted as a list of approved substances. Instead, it serves as a precedent-of-use reference, indicating levels and routes of administration that have been previously accepted in approved drug products.

While utilizing an excipient within these established precedents usually facilitates a smoother review, the FDA maintains the authority to require justification for any excipient's use in a new drug context. Understanding this distinction may help pharma companies navigate the path from formulation development to regulatory submission.

FDA. Inactive Ingredients in Approved Drug Products Search: Frequently Asked Questions. 

. January 26, 2022. Accessed April 29, 2026. 

https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-approved-drug-products-search-frequently-asked-questions

FDA. Inactive Ingredients Database Download.

. April 13, 2026. Accessed April 29, 2026. 

https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-database-download

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

Medical Drug Production Plant. Insulin Injection Pens on Conveyor Line during Production Process at Modern Pharmaceutical Factory. Weight Loss Medication Manufacturing. | Image Credit: ©IM Imagery -stock.adobe.com

Visual inspection of injectable products can prevent the potential of harm to patients. The FDA provides guidance for the development of a risk-based approach to detecting, controlling, and preventing visual particulates in injectable products.

 These types of products include the typical vial and syringe products and prefilled syringe combination products. But is there a difference in how these products are inspected? Does the nature of a combination product where the drug is inside the delivery mechanism create additional complications to visual inspection?

 spoke with Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group to find out what challenges prefilled syringes may hold.

PharmTech: What makes visual inspection of prefilled syringes different than visual inspection of vials?

 Visual inspection of prefilled syringes is more challenging than vials due to [the prefilled syringes’] geometry and handling requirements. Syringes must be oriented needle-up to detect particles resting on the plunger (stopper), adding complexity to the process. The presence of the plunger prevents bottom-up illumination and limits the use of the Tyndall effect, requiring alternative lighting from the top or sides.

The narrow barrel restricts fluid movement, often necessitating higher spin speeds to mobilize particles. Additional challenges include particles trapped between the stopper and barrel, air bubble movement during reorientation, and inspection of plunger ribs and fill level.

Are there new technologies available for conducting visual inspection of prefilled syringes?

Yes, several innovations are improving both handling and detection performance. One key advancement is the elimination of glass-to-glass contact during handling, which ensures smoother syringe transport, reduces vibration, and minimizes bubble formation that can interfere with inspection. Modern turnover devices are also designed to gently invert syringes (needle-down to needle-up), avoiding unnecessary liquid disturbance.

On the inspection side, AI [artificial intelligence]-native systems are increasingly adopted to enhance defect detection while significantly reducing false rejects. These systems learn from real production data and improve over time.

How can container closure integrity testing be automated?

Container closure integrity testing (CCIT) can be fully automated by integrating high-voltage leak detection (HVLD) directly into the automated inspection machine (AIM), enabling true 100% in-line inspection. This approach allows simultaneous cosmetic, particle, and leak detection within a single platform, improving efficiency and reducing handling.

HVLD is particularly effective for liquid-filled, conductive products in standard glass containers, with the capability to detect leaks down to approximately 2-micron pinholes under optimal conditions. Systems can reach speeds up to 400 parts per minute for prefilled syringes. At Antares Vision Group, this integration ensures robust, non-destructive CCIT is directly integrated into the inspection workflow.

How does the viscosity of liquids complicate the filling of prefilled syringes? How does it impact traditional vial/syringe delivery?

This is not related to inspection machines; however, high-viscosity or gel-like products significantly challenge visual inspection because particles do not move freely after the spinning phase. This limits the effectiveness of traditional particle inspection methods based on spin–stop–analysis, which rely on particle motion to create contrast. As a result, inspection must shift toward a more cosmetic-like approach.

At Antares Vision Group, viscous products are inspected using continuous 360° rotation with multiple image acquisitions (up to ~75 images). Advanced tracking algorithms analyze object behavior over time to determine whether a defect is internal or external, with AI-native systems supporting robust detection while minimizing false rejects.

Inspection of Injectable Products for Visible Particulates, Guidance for Industry.

. December 2021. Accessed April 29, 2026. 

https://www.fda.gov/media/154868/download

Daniele Ansaldi is technical manager for Automated Inspection Machines (AIM) at Antares Vision Group North America.

Daniele Ansaldi is technical manager for Automated Inspection Machines (AIM) at Antares Vision Group North America. Daniele is responsible for defining and aligning technical solutions across the full lifecycle—from pre-sales engineering to after-sales support and leads a multidisciplinary team composed of Field Service Engineers, an automation specialist, a mechanical designer, and a project manager.

Daniele has more than 25 years of experience in the inspection industry, starting in 1999 as a Field Service Engineer and progressing through roles such as Commissioning Manager, Regional Field Manager, and Customer Service Manager with leading global AIM manufacturers.

In the April 2026 episode of Ask the Expert, Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, address the complexities of investigating patient complaints regarding pre-filled syringe (PFS) and combination products. Schniepp and Schmitt make it clear; for manufacturers who purchase commercial syringes for their drug products, the marketing authorization holder (MAH) remains ultimately responsible for product performance, regardless of their level of control over the component manufacturer. 

Articles

Visual inspection of prefilled syringes is intrinsically more complex than vial inspection due to syringe geometry, required needle-up orientation, and plunger-related optical and mechanical constraints. Limited bottom-up illumination reduces applicability of Tyndall-based approaches, while narrow barrels impede fluid agitation and can trap particulates near the stopper. Newer systems improve transport by eliminating glass-to-glass contact and using gentler inversion. AI-native inspection reduces false rejects. In-line HVLD integration enables 100% automated CCIT alongside cosmetic and particulate inspection, including high-speed throughput.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

The Challenge of Visual Inspection of Prefilled Syringes

PharmTech Weekly Roundup-April 24, 2026

This week’s stories reflect the push to modernize facilities and manufacturing processes, the mounting impact of trade policy on the supply chain, and the persistent challenge of getting the right drugs to patients reliably.

ISPE recognized six facilities across the year’s 

, with winners spanning synthetic DNA manufacturing, plasma fractionation, and cell therapy—recognizing the global standard for what pharmaceutical facilities can achieve.

key first-year goals under its 2025 Roadmap to Reducing Animal Testing,

 advancing new approach methodologies—including computational modeling and organ-on-a-chip systems—as more scientifically accurate alternatives to animal studies.

The US Customs and Border Protection launched its 

on April 20, 2026, providing a way for pharmaceutical importers to reclaim funds following a February Supreme Court rebuke of executive tariff authority.

Asahi Kasei has completed its acquisition of German biotech Aicuris,

 adding three antiviral assets targeting severe infections in immunocompromised patients—a move that deepens its specialty pharma platform in transplantation and infectious disease.

Our editors were at INTERPHEX in New York this week, attending conference sessions and interviewing experts. One of the sessions discussed how the next 

must balance automation, digital integration, and sustainability while meeting regulatory expectations—requiring manufacturers to rethink both design and operational strategies.

Todd Vaughn and Christa Myers of CRB Group

 about how contamination control requirements and revised GMP Annex 1 standards are driving robotics adoption in aseptic manufacturing, with fully automated, gloveless isolator systems moving from emerging technology to operational expectation.

Experts from Merck, AstraZeneca, J&J, Regeneron, and Basetwo AI expressed that, despite broad interest in AI across drug discovery and manufacturing, there are 

—with data fragmentation, regulatory uncertainty, and workforce skills gaps remaining the primary barriers to scale.

Optimized CDMO facility design is increasingly defined by flexibility—modular layouts, multi-product capability, and digital infrastructure—allowing contract manufacturers to onboard new programs faster while maintaining GMP compliance, according to 

, who spoke with PharmTech ahead of his INTERPHEX quick fire session.

Rohan Kumar, laboratory analyst at CS Analytical 

highlighted that while interest in sustainable pharmaceutical packaging is growing, significant gaps remain between industry ambitions and commercially viable, regulatory-compliant solutions.

episode discusses how combination products present unique complaint investigation challenges because responsibility often spans multiple components and regulatory frameworks—making cross-functional coordination and clear root-cause methodology essential for compliance.

The industry is under pressure to modernize faster, build supply chains that can absorb disruption, and close the gap between technological ambition and operational reality. Stay current with industry news and trends at PharmTech.com.

The industry is feeling the push to modernize facilities and manufacturing processes. 