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Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?

Science, Empiricism, and Off-label Use

*Test what you learn with a 3-question quiz at the end of the article!

What would it be like to reduce the audit trail review (ATR) burden in laboratories and manufacturing spaces all while satisfying inspector expectations? With more than 100 external inspections of Eli Lilly and Company’s commercial manufacturing sites conducted in the two years since the company published a novel and enhanced ATR assessment process, Lilly has established a sustainable and tested approach. This article describes how the company was able to achieve this.

Based on both external evaluation and internal assessment, the need to examine the data integrity (DI) governance program to ensure it remains in alignment with current regulatory expectations was determined. One area identified for further review was ATR. At that time, a need to make the ATRs more consistent was recognized, and the global requirements also needed to be enhanced. Additionally, requirements for data review needed to be more standardized. These enhancements were essential to maintaining trusted data and meeting ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available) principles.

Desiring to upgrade the approach across all sites, external consultants were hired to help build an enhanced global ATR process. However, the implementation of this global process was not specific enough, and uncovered potential inconsistencies in implementation, confusion from site and global teams, and frustration about the global process being too open-ended. Because the implementation strategy was open to local interpretation, information technology (IT) support teams were responsible for determining how to assess their systems and independently determined the DI gaps that needed an ATR. They also determined the justification for DI gaps that would not have an ATR. These independent assessments of the global ATR process were not sufficient to support an overall implementation, so a more holistic approach was needed. With the advances in technology in the pharmaceutical industry, as well as evolving regulatory expectations, a more specific and global process was warranted.

As a result, a centralized data management team was added to the organization to ensure sustainable DI processes were developed and maintained. This team is an independent, strategic, global quality and compliance-level team that supports all functions across operations, research, and commercial. This team is fully dedicated to DI governance and is a key organizational component that establishes DI policy.

To create a more robust ATR process, the original process’ authors were interviewed to understand theprocess state, and site and global teams that had started to use the first version were also consulted. It was determined that global data management needed to provide more specific ATR tools to the local manufacturing teams so they could continue to focus on producing high-quality products. The available regulations and industry guidance were then studied that govern ATR (

). Lastly, a deep dive into the existing established DI requirements was performed, and it was determined that they were strong and well-developed. The conclusion of the research was that the company needed an ATR assessment process that was comprehensive and robust, but also easy to follow, keeping in mind the end users’ experience with ATR.

Cross-referencing the company’s DI requirements with the industry regulations and guidance, a specific set of logical controls were documented as expected controls for identified DI vulnerabilities. If systems could not be configured with the expected logical control, minimum ATR activities are expected to be performed and were consequently outlined for each DI vulnerability. Therefore, the result of following this process would mean that DI requirements are either met through a logical control or ATR is performed to mitigate the vulnerability, ensuring no compliance gaps.

The workflow for developing an ATR assessment process is represented in 

The following process was designed for areas to use when evaluating their ATR responsibilities. A lead assessor from the quality, business, or IT group would be appointed and organize the appropriate team of subject matter experts (SMEs) to assess the system. Assessment teams would then:

evaluate potential DI risks based on the established minimum DI requirements

determine if there are the specified logical controls in place that mitigate each risk

document the ATR expectations when those controls do not exist.

This three-part assessment process was expanded upon in a global standard operating procedure (SOP), and an assessment template was created to make it easy for teams to pick up and utilize. When ATR is required, teams follow the process in 

 shows two hypothetical examples of how the process can work with this ATR process flow if the requirement is “end users must not have the ability to modify or delete output data.” These examples are provided for illustrative purposes only, as each company will have its own systems and controls and should not rely on these specific examples.

The assessment process would look like this:

Notice the template phrasing above is “Do users have the ability…?” It is not “Will they…?” Phrases like “Will they…?” or “Can they…?” imply a procedural control is acceptable, and a procedural control is not an acceptable control strategy in the industry. Although a determination of “No Audit Trail Review required” is made in the second hypothetical example, keep in mind there may be additional data reviews for batch release based on other requirements or different regulations. However, if there are logical controls in place that have been validated, the data integrity risk drops significantly.

Novel, enhanced, sustainable approach for ATR

The newly structured ATR SOP has been well-received, and teams were eager to use the assessment template. There is an added benefit in that the SOP has transformed employees’ understanding that if a system can be designed and validated to meet the expected controls in the assessment, a review is not needed, and the time and expense of performing non-value-added data reviews is drastically cut. An in-depth training program was also established and rolled out to every manufacturing site and global support team. The training program introduced the novel and enhanced process and instructed teams on how to effectively assess systems for their ATR needs. This process has directly translated into other improvement initiatives and is another tool to complement the DI by design approach when implementing new systems. This means that systems are designed to meet the expected control instead of the required long-term reviews that would otherwise be required. And when an ATR is required, there is a globally consistent approach that can stand up to external audits.

In conclusion, a more sustainable ATR assessment process was developed and implemented that reduced the ATR burden, enhanced DI compliance, and aligned with current good manufacturing practice expectations. The process involved a three-part evaluation of potential DI risks, logical controls, and ATR expectations based on a set of internal DI requirements and industry standards. The process also led to improved system designs that meet the expected controls and more specifically define when an ATR is needed. The procedure has been completely integrated into the manufacturing space and has been able to withstand external scrutiny.

Diana Russo has more than 20 years of experience in the pharmaceutical industry. She has built her career in the areas of computer system validation, IT quality, and computer systems quality assurance. And while her current role focuses on data integrity, DI has been an important driving force throughout her entire career. She is an audit trail review subject matter expert, a leader in process improvement, and happily challenges the status quo.

Eli Lilly and Company has developed a sustainable and enhanced audit trail review (ATR) process to reduce the burden on laboratories and manufacturing spaces while meeting regulatory expectations. The process involves a centralized data management team and a three-part evaluation of data integrity (DI) risks, logical controls, and ATR expectations. This approach aligns with ALCOA+ principles and current good manufacturing practices. The new ATR standard operating procedure (SOP) has been well-received, leading to improved system designs and a globally consistent approach that withstands external audits.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

PharmTech News

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Video interview at DCAT with Frank Romanski, PhD, from Lonza CHI

Inside Lonza CHI’s Innovation Engine: Future-Ready Capsules for Complex Drugs

Frank Romanski, Ph.D., Global VP of Strategic Growth & Revenue Management at Lonza CHI, shares how the company is advancing both product and process innovation to support the next generation of pharmaceutical therapies. From addressing the challenges of biologics and complex formulations to delivering sustainable manufacturing solutions and unmatched service, Lonza CHI is partnering with customers to meet the evolving demands of the pharma industry. Ultimately, Lonza CHI is helping bring smarter, more effective drug delivery systems to life globally.

How Lonza Capsules & Health Ingredients (CHI) is redefining drug delivery with cutting-edge capsule innovation, customer-first service, and a strong commitment to sustainability

Inside Lonza CHI’s Innovation Strategy: Future-Ready Capsules for Complex Drugs

*Editor's note: article updated on March 3, 2025 to fix typographical errors.

Following a long road to success with antibody-drug conjugates (ADCs), developers today are seeing regulatory approvals for ADCs as a more common occurrence. Better success in the current environment is largely due to technology improvements that have helped minimize risk and enhance therapeutic efficacy for these complicated drugs. However, the manufacturing of ADCs remains a complex process, involving requirements for both the large-molecule and small-molecule components. The linker technology joining the two pieces also has its own requirements. Because of their manufacturing complexity, ADC development and production increasingly requires outsourcing services.

Three major challenges for drug developers trying to bring ADCs to market include lack of capacity, lack of expertise in scaling up, and the complexity of the supply chain, notes Christian Morello, vice-president and head of the Bioconjugates Business Unit at Lonza.

In looking at the overall dynamic of innovation in the ADC space, the majority of innovation is coming from small biotech companies, and those companies are not necessarily well equipped with the internal capacity to produce the product, Morello points out. “There is also a lack of knowledge about the industrialization and the scale up of ADCs,” he says. “And [there is also] the complexity of the supply chain; Indeed [we] within the bioconjugate field, we are bringing different pieces, like a puzzle, to produce the drug substance. It implies [much] complexity [and requires] management of different sourcing in order to make it happen.”

These challenges are what ADC developers have to face and overcome to produce clinical supply or commercial supply, Morello emphasizes. “This is where CDMOs [contract development and manufacturing organizations] bring a lot of benefit, because we have [experience with] different modalities. [Especially at Lonza,] we’re totally integrated, so we offer fully integrated services to make it happen and to accelerate [the developer’s] path to commercialization,” Morello says.

ADCs have unique manufacturing requirements, which is part of their complexity. “With ADC specificity, we are merging two worlds,” explains Morello. “We are merging the water and the solvent, the biologic and the chemistry. So, with this integration of two worlds, it requires specific skills.” Morello also cautions carefulness when dealing with the risks associated with the chemistry involved in ADC manufacture. “You need to take care about potential explosion or flammable risk associated [with] the chemistry, but you also need to take care about the potential contamination due to microbes if you’re not working with adequate procedure for clean environment. So, the operating model is very specific.”

The science of ADCs has evolved significantly over the past 20 years, Morello also points out. Many improvements can be seen in the carrier component (protein or peptide), the linker component, and the payload, all of which makes the conjugation technology more complex.

“There have been a lot of new developments in terms of conjugation and linker technologies,” agrees Nicolas Camper, senior director, Bioconjugation, at Abzena. “There is a definitive move towards site-specific conjugation technologies and away from stochastic conjugation approaches that allows [us] to prepare better-defined antibody-[drug] conjugates,” he says.

Camper also points out another new development that he’s observed over the past few years, which is that linker technology is becoming more sophisticated. “Quite often, when you conjugate cytotoxic drugs, they are quite hydrophobic, and that can impact the performance of your ADC. So, there has been a lot of effort put into developing more hydrophilic linkers,” he explains.

Another noticeable advancement has been in the development of branch linkers. These branch linkers give some options for preparing the ADC and modulating the drug loading. “[T]hat is something relatively new and should have an impact on the performance of ADCs and ultimately result in better ADCs and more programs,” he says.

Technological gaps are one area of unmet need in the ADC space. In Lonza’s case, the CDMO realized it needed a certain technology that would be valuable to its customers, which prompted it to acquire the Netherlands-based Synaffix in 2023 (1). Morello explains that the technology Synaffix brings offers a new way to do the conjugation “where we are connecting the linker at the glycan location on the mAb.”

“That is something that no one else has,” Morello emphasizes. This technology specifically addresses the challenge of how to manage the number of linkers and payload that can be connected to the carrier, the mAb. “So, it brings some solution to address the needs the customer has,” he says.

Morello also notes that Lonza is following the evolution of conjugation technology day-to-day to be able to capture new technologies and bring the best solutions to customers. “We have also created a toolbox [where we] identify very innovative companies/technology outside, bring them into the [Lonza] network, and identify where the customer may require this type of support, and then facilitating, connecting this technology at an early stage,” Morello states.

“When it is confirmed that [a] molecule is really interesting … then [we use] our ability to … master this very breakthrough technology [and bring it] into an industrial and GMP [good manufacturing practice] environment and to scale up this technology to support Phase I, Phase II, or Phase III [development], and then, later on, [scale up to] the commercialization of the drug,” Morello says.

ADC development has a robust future with much potential. Camper points out an important aspect currently driving ADC development: diversification. “I think that we’ve seen a lot of diversification. That’s a key word. The increased diversity can be noticed in the targeting moiety. Smaller targeting fragments, which allow for better penetration into the tumors, are being developed as targeting moieties; that can be nanobodies or fat fragments,” he explains.

“There is also diversity which is encompassed in the use of bispecific antibodies. They allow for targeting more selectively cancer cells,” Camper says. Camper also notes that there is a lot of diversity today in the payloads. “Traditionally, they were cytotoxic payloads, but, now, people are revisiting all potent small molecules, such as potent kinase inhibitors or payloads that have radically different mechanisms of action, such as molecular glues or PROTACs [proteolysis-targeting chimeras].”

Camper additionally observes how, in the past few years, there has been development of bioconjugates outside the area of oncology. “There are lots of antibody-drug conjugates being developed for the treatment of inflammation, for instance, or—something which is extremely hot at the moment—the development of antibody oligonucleotide conjugates for the treatment of genetic disorders,” he states. “Having access to more complex and linked payloads and conjugation technologies—more advanced conjugation technologies—that definitely results in better therapeutic profiles for antibody-drug conjugates, and we’ll see more and more of those in the future.”

“The technology is now at the level of maturity that enable a lot of different things,” adds Morello. For instance, going back to Lonza’s Synaffix acquisition, Synaffix presents another type of linker technology in which the developer can define how many payloads it wants to have per mAb. “That is another possibility that will enable [the developer] to fine tune the benefits/risk ratio for the patient,” Morello states. “We can see [that] today for some cytotoxic compounds for oncology, for sure, but we also have radiolabeled compounds to facilitate diagnosis. [This is] also oncology treatment, but with a different approach.”

“We have nucleotide and mRNA [messenger RNA] that are more and more used for some applications. We have polysaccharides that are also used as a vaccine. So, the applications associated with bioconjugation is much broader than it was in the past,” Morello says.

In addition, Morello points out, when looking at the overall portfolio of clinical trials that are ongoing in the bioconjugates field, half of them is associated with oncology applications and the other half is associated with non-oncology products. The ability to tackle different type of disease is one clear direction where ADC development is heading. Another area is having the ability to improve the benefits/risk ratio to decrease side effects, particularly in oncology, while increasing efficiency. Being able to target a specific ratio of linker to payload to mAb is also an interesting area, he adds. 

“Last but not least is the ability to simplify the process, again, through more integration,” Morello states. “We will need to accelerate the time to market and will accelerate, as well, the time to commercialization.”

1. Lonza. Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering. Press Release. June 1, 2023.

®
Vol. 49, No. 1
January/February 2025
Pages: 29–30

When referring to this article, please cite it as Mirasol, F. Advancing ADCs to the Next Level. 

CDMOs who have integrated technologies can help further the advancement of ADC development.

Advancing ADCs to the Next Level

Nicolas Camper, senior director—Bioconjugation Chemistry, Abzena, discussed new advancements in ADC technologies, including the role of complex chemistries.

CPHI Milan 2024: New Developments in ADC Technologies

*Editor's note: updated on March 3, 2025 to fix typographical error.

spoke with Nicolas Camper, senior director—Bioconjugation Chemistry at Abzena during CPHI Milan. Camper discussed the advancements in conjugation and linker technologies in antibody-drug conjugate (ADC) development and manufacturing. 

“There have been a lot of new developments in terms of conjugation and linker technologies. There is a definitive move towards site-specific conjugation technologies and away from stochastic conjugation approaches that allows [us] to prepare better-defined antibody-[drug] conjugates,” Camper said.

Another new development that has been observed over the past few years is that linkers are becoming more sophisticated. “Quite often, when you conjugate cytotoxic drugs, they are quite hydrophobic, and that can impact the performance of your ADC. So, there has been a lot of effort put into developing more hydrophilic linkers,” he noted.

Finally, another noticeable advancement in this area has been the development of branch linkers. Branch linkers give some options to prepare ADCs and modulate the drug loading, Camper explained. “[T]hat is something relatively new and should have an impact on the performance of ADCs and ultimately result in better ADCs and more programs,” he stated.

In his role at Abzena, Camper has scientific oversight of the group’s R&D activities focusing on ADC design and developability for external clients. His responsibilities involve technical management of pre-clinical ADC development projects from discovery stage to lead candidate selection. The group has expertise in synthetic chemistry, assembling linker-payloads, conjugation of the linker-payload to various types of protein carriers (primarily antibodies), and analysis of these bioconjugates.

Attendees can visit Abzena at Booth 18H11. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

Latest Conference

CPhI News

This story has been updated to include a comment by Glenn Wright, president and CEO of the Parenteral Drug Association.

An email communication, dated Jan. 10, 2025, released by FDA’s Center for Drug Evaluation and Research (CDER), announced the retirement of CDER Director, Patrizia Cavazzoni, effective January 18.

Cavazzoni joined FDA in 2018 as deputy director of operations in CDER and also served as acting principal deputy commissioner of Food and Drugs briefly in 2019. She was made director of CDER in 2021. Prior to working with FDA, Cavazzoni spent several years working in the pharmaceutical industry in the areas of clinical development, regulatory affairs, and safety risk management (1).

In a letter to her CDER colleagues announcing her retirement, Cavazzoni praised her team for how it handled the COVID-19 pandemic and the growth the center has shown in her years as director (2).

“While I could spend a lot of time enumerating our achievements, I want to highlight our biggest success: our people and our culture,” Cavazzoni said in the letter. “As I leave CDER, I can say with confidence that the Center is at its strongest. We have hired and retained record numbers of the best scientists and professionals. We have built a cohort of world-class managers and executives who are solidly at the helm of our organization and will continue to lead CDER. And most important of all, we created a culture that fosters respect for one another, inclusion, accountability, and diversity of thought and life experience. Our culture is what makes us strong and resilient, and it’s the foundation of what we have accomplished and will accomplish in the future.”

As of the time this article was written, FDA has not yet announced a replacement for Cavazzoni. Her predecessor, Janet Woodcock, was CDER director from 1994 to 2004 and then again from 2007 to 2021 (3).

®, Glenn Wright, president and CEO of the Parenteral Drug Association (PDA), said the following about Cavazzoni's retirement: 

“On behalf of PDA and our many industry members worldwide I thank Dr. Cavazzoni for her work as the CDER Center Director within FDA. Her efforts to move the industry and FDA forward to better serve patients is much appreciated. Communication between FDA and Industry is an essential part of ensuring expectations are well understood and concerns and issues raised. Her openness, and that of the Center she leads, to meet with Industry on topics of importance, speak at conferences and attend stakeholder meetings has been very helpful in this rapidly changing world.”

FDA. Patrizia Cavazzoni, M.D., Director–Center for Drug Evaluation and Research. FDA.gov. April 12, 2021. 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/patrizia-cavazzoni

CDER Trade Press. CDER Director Patrizia Cavazzoni to Retire from FDA. Email Correspondence. Jan. 10, 2025.

FDA. Janet Woodcock, M.D. FDA.gov. Feb. 1, 2024. 

https://www.fda.gov/about-fda/fda-organization/janet-woodcock

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Cavazzoni Retires as CDER Director

Experts in cell and gene therapy weigh in on hot topics in a quick-hitting buy, sell, hold format before expanding their thoughts on complex questions. 

Buy, Sell, Hold: Cell and Gene Therapy - Part 1

 is a rapid-fire expert panel covering a single topic, such as lipid nanoparticle delivery, supply chain resilience, 

 (CGT), or aseptic filling. Panelists first respond to quick-hit questions with a buy, sell, hold format before being allotted more time to share more considerate responses to complex topics.

While finance and investment perspectives flavor the discussion, science and pragmatism are the main ingredients driving these dynamic panel discussions.

“Episode 1: Cell and Gene Therapy” features the expertise of Fabian Gerlinghaus, co-founder and chief executive officer of Cellares; Dr. Claudia Zylberberg, board chair and co-founder of Arscience Biotherapeutics, and board chair and co-founder of Akron Biosciences; and Benjamin McLeod, director, Cell & Gene Therapy Segment, at NanoMosaic.

In the first 2 segments, the panelists share quick thoughts on CGT topics, including: The merits of focusing on orphan diseases; training new staff versus re-training existing staff; machine learning, artificial intelligence, and quantum computing; existing supply chain functioning; government investment into CGT; using traditional CDMOs for CGT production; facility retrofits for CGT; and CGTs as first-line treatment.

In the final segment, panelists had up to two minutes each to weigh the advantages and disadvantages of gene editing (CRISPR), gene augmentation, and gene-silencing approaches. Panelists also discussed their technology or engineering wish lists, as well as how to best to sync up regulations to current technology progress. Lastly, they exchanged ideas about the key missing piece(s) to lowering cost and improving accessibility.

Click here for more episodes of Buy, Sell, Hold

Fabian Gerlinghaus, Co-Founder and CEO, Cellares

Fabian Gerlinghaus is Co-Founder and Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about building the future of cell therapy manufacturing. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honors degree in technology management from the Center for Digital Technology and Management, Munich

Dr. Claudia Zylberberg, Board Chair and Co-Founder Arscience Biotherapeutics, Board Chair and Co-Founder Akron Biosciences

With over 30 years of experience in the regenerative medicine industry, Dr. Zylberberg has established herself as a leader in her field. For nearly 15 years, she led Akron Bio as its founder and CEO with leadership, foresight, and expertise in advanced therapies manufacturing. Her passion for pushing the industry forward in the development and commercialization of safe novel therapies also led her to co-found the Standards Coordinating Body and serve as an active member of numerous industry boards and advisory committees. Claudia co-founded AssureImmune, an adult stem cell bank, and worked with Nabi Pharmaceuticals, specializing in human plasma-derived products. Her experience in product development and protein manufacturing was instrumental in the development of key materials to accelerate the regenerative medicine industry. She holds numerous patents and developed several patent-pending platform technologies in cryopreservation, novel formulations, and others. Claudia received her PhD from the University of Buenos Aires, where she studied Immunology, and conducted her doctoral research at the University of British Columbia. She also authored a children’s book called You’re Full of Genes to introduce the younger generation to genetics. Claudia is a member of the Forum on Regenerative Medicine at the National Academies of Sciences, Engineering, and Medicine.

Benjamin McLeod, Director, Cell & Gene Therapy Segment, NanoMosaic

Currently Benjamin helps many related researchers become more familiar with CGT concepts by translating complex processes into digestible bites on social media platforms such as LinkedIn and X. At OmniaBio he was product manager, collaborating with technical stakeholders to develop clear and actionable messaging around OmniaBio’s manufacturing services. At Virica Biotech he was Technical Lead, for a company whose viral sensitizer technology, increased viral yield in manufacturing, and potency in viral therapeutic products.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT. 

Janice M. Hogan

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