Grant Playter

Croda Pharma, a biopharmaceutical excipients, vaccine adjuvants, and lipids provider, recently broke ground on its newest manufacturing facility in Lamar, Pa. The 23,680 ft² excipients facility will manufacture ingredients for drug delivery systems used in novel therapeutic drugs, including mRNA vaccines and gene editing therapies. It will also support production of lipids that are already used in therapeutics and vaccines, as well as “next-generation” therapeutics that are currently being developed, such as lipids for novel cancer treatments. The new facility will begin construction this year and is expected to be completed in 2025.

“There are rare moments that a team can contribute to such a significant betterment of humankind,” said Bradley Cook, vice-president, North American Operations, Croda, in a May 31, 2023, press release. “The on-going collaboration with the Department of Health and Human Services and its premier biomedical countermeasure development agency, BARDA, has afforded Croda and this team the opportunity and we are extremely excited and proud.”

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The new excipients manufacturing facility is expected to be completed in 2025.

Croda Pharma Breaks Ground on Excipients Manufacturing Facility

Merck, known as MSD outside of the United States and Canada, announced that it had officially filed a complaint against the US government on June 6, 2023. According to a company statement, the complaint alleges that the price controls introduced by the Inflation Reduction Act (IRA), which require the Centers for Medicare and Medicaid Services to begin setting prices on small molecule medicines at nine years and large molecule medicines at 13 years, are unconstitutional and will stifle biopharmaceutical innovation.

The complaint cites the Fifth Amendment, which states that the US government must pay “just compensation” if it takes property for public use. In the statement, Merck argues that the IRA allows the government to coerce Merck to provide biopharmaceutical innovations without providing equitable value for them.

“Patients and the public need biopharmaceutical innovation to address global health challenges like cancer and Alzheimer’s disease, and the IRA is negatively affecting critical research and development,” reads the statement. “By changing the incentives and returns for some therapies and technologies over others, the IRA is changing the course of R&D, which in time will leave many patients without treatment options.”

“The Biden-Harris administration is going to fight attempts to go back to the way things were before,” said Karine Jean-Pierre, White House press secretary, in a statement to the press regarding the suit. “And so, we are confident we will succeed. There is nothing in the Constitution that prevents Medicare from negotiating lower drug prices. Anytime profits of the pharmaceutical industry are challenged, they make claims about it hindering their ability to innovate.Not only are these arguments untrue, but the American people do not buy them.”

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

Merck Files Lawsuit Against US Government

Waters Corporation and Sartorius announced a new analytics collaboration on June 5, 2023. This agreement, which expands on their existing agreement that focused on upstream bioprocessing analytics, aims to develop integrated analytical solutions for downstream biomanufacturing.

According to a company press release, the collaboration will use Waters’ liquid chromatography and Sartorius’ multi-column chromatography platforms to develop a more comprehensive analytical data solution. This system will be used for downstream batch and continuous manufacturing with the goal of improving yields, reducing waste, and cutting costs.

“From the beginning of our collaboration with Sartorius, we’ve strived to give bioprocess engineers faster and more direct access to critical quality attribute information about their drug products in the name of improving production yields and getting drugs to patients faster,” said Jon Pratt, senior vice-president, Waters Division, in the release. “Based on the positive response of customers to our collaborative efforts with upstream bioprocessing analytics, we see tremendous benefit to combining [our platforms] to bring timely point-of-decision analytics to downstream biomanufacturing for monoclonal antibodies, recombinant proteins, vaccines and AAV gene therapies.”

“Now that intensified, continuous manufacturing of biologics is becoming a reality, there is a greater need for real-time analytical measurement,” said René Fáber, head of Bioprocess Solutions Division, Sartorius, in the release. “The value of combining technologies from Sartorius and Waters lies in bringing fundamentally important analytics to the point where it is needed and giving bioprocess engineers a more complete understanding of their downstream manufacturing processing and its effects on drug product quality. We believe this can have significant impacts on drug production costs by helping to increase yields and reduce waste.”

Sartorius and Waters will collaborate to develop integrated analytical solutions for downstream biomanufacturing.

Sartorius and Waters Expand Analytics Collaboration

Domino Data Lab, a data science and artificial intelligence (AI) platform company, announced various new capabilities at the Rev 4 conference on June 1, 2023. The expansions to the company's MLOps platform for developing and deploying custom large-language models and generative AI applications are designed to enable democratized access to various AI ecosystem changes. Expansions include a new AI project hub, additional cloud-based offerings, and the Model Sentry capability suite.

The new AI project hub uses pre-trained foundation models and project templates to connect users and enable them to select an optimal foundation model as well as to connect users to their data and generate code to fine-tune that data. The hub also has various auto-scaling compute clusters for large-scale distributed data preparation and model training.

The company’s new cloud offerings include Domino Cloud for Life Sciences (DCLS), an audit-ready specialized AI cloud platform intended for use in the pharmaceutical industry. DCLS is designed to accelerate drug discovery, optimize research workflows, and maintain strict regulatory compliance within a secure, collaborative, and fully managed platform.

The Model Sentry is a suite designed to mitigate model risks, implement responsible AI practice, and eliminate AI development overspend. The solution uses a unified model registry for complete lineage tracking, as well as automated model cards for auditing purposes.

"AI is an existential business imperative. The winners will be those who wield it with speed, responsibility, and fiscal savvy," said Nick Elprin, CEO and co-founder of Domino Data Lab, in a company press release. "We're backing our customers with the resources to outshine in these key areas and unleash AI to change the trajectory of civilization."

Domino Data Lab's expanded platform includes a new project hub, additional cloud offerings, and the Model Sentry solution suite.

Domino Data Lab Expands AI Platform

Given the rapid advances being made in technologies such as cell and gene therapies, personalized vaccines, and oral biologics, odds are high that there’s some hot ticket item demanding one’s attention at any given time. While it would be foolish to detract from the monumental discoveries being made in the biopharma field, new technologies should nevertheless be approached with some degree of caution. While innovation is crucial for the benefit of patients and industry alike, many start-ups, often brimming with ideas and ultimately unrealized potential, have been felled by trying to sprint before they even stand. Leadership cannot afford to split their attention if the nuts and bolts of an organization aren’t properly fitted.

Nowhere is this more evident than in data integrity, which measures data accuracy, completeness, and cohesiveness. It certainly doesn’t have that je ne sais quoi that entices ones like a monumental technological, but it is nonetheless foundational to the day-to-day operations and overall success of a company. Perhaps Big Pharma companies can afford the occasional $8.9 billion misstep (1); but whether your Amazon (2) or Santander (3), regulatory fines can easily balloon to a painful price point.

Particularly in an industry as heavily regulated as pharma, where data silos, compliance errors, or security breaches must be taken gravely serious because of their direct impact on patient outcomes, maintaining property data integrity is absolutely paramount to a company’s success. In this vein, this article explores the common pitfalls companies run into, the consequences thereof, and how one can structure their data integrity programs.

The crux of good data integrity are software and data management tools, as they are an immense boon when working with the voluminous amounts of data typical of the pharma industry. However, one must consider the types of data they are using before building out a data integrity process. Paige Kane, member of the Pharmaceutical Regulatory Science Team at TU Dublin, and Garry Wright, European laboratory compliance Specialist at Agilent Technologies, spoke at length on this topic in an episode of 

“We need to understand what our processes are, what data we are trying to capture, and make sure that we have the right tool for that application,” said Kane. “And when we do that, we need to take a risk-based approach and understand where the risks are, and where the operators are intersecting with that and where we can be error-proof. Leveraging automation is a great way to do that.”

Per Kane, companies that are looking to tighten up their operations should consider the purpose of the data they are collecting and why they need it. Superfluous data can result in greater system and operator burden, while missing requisite data fundamentally undermines the purpose of the system.

However, this doesn’t just apply to collection methods—it also impacts who can interface with the data, and in what ways. Wright noted that some of the most common pitfalls in data integrity concern have been plaguing the data integrity industry for as long as it has existed.

“We’ve been talking about data integrity for the last 10 years, but there’s still a lot of repeated data integrity violations out there,” said Wright. “Some of them are very basic, fundamental requirements of using software in order to protect data.”

Some of the most common problems Wright listed in the interview include:

 This obfuscates which users accessed a particular system, and if given out broadly can make it difficult to trace the origin of errors or cases of intentional falsification. To enable a broadly successful data integrity system, it’s crucial to have unique logins that operators can track.

Often, scientists and various technicians are given more access to systems than needed for their role. This can lead to a conflict of interest where a bad actor approves a failed batch, or where bad test data are altered or deleted to avoid investigations or re-tests.

 Many companies have received warning letters because they have chosen to not activate certain audit privileges—making it impossible to track changes and properly oversee a system. Similarly, even when they are activated, users who shouldn’t be able to access audit technology are often able to do so, allowing bad actors to compromise data integrity.

While implementing a wholesale data integrity program can seem daunting, Kane was quick to note that there are many guidance documents and resources available that can help companies get over initial hurdles. What is pivotal is that company leadership act in good faith and invest in the types of processes and technologies that keep pharmaceutical data honest and intact—in short, enact a full-scale data governance policy.

“It’s more than just the audit trails,” said Kane. “There needs to be a holistic view and approach as to how we’re going to manage our data so that we can put forth that holistic picture to our inspectors and customers.”

Inherent to the discussion of data integrity is the discussion of automation, and within that the de-emphasis of human intervention in various tasks throughout the pharma lifestyle. Human error is a major concern for pharma companies, as one mistake (or deliberate falsification) can have severe knock-on effects for the patients ultimately receiving the compromised medicines. Automated processes are a fantastic alternative, particularly for precise, time-intensive tasks that need to be repeated thousands of times a day—the ubiquity of automated
production lines is a prime example of this principle in action.

However, it is crucial that companies understand that “de-emphasis” does not mean “elimination.” It’s common corporate philosophy to have workers perform to the highest function available—a CEO isn’t typically charged with data entry, even if they’re perfectly capable of doing so, because there are higher-level functions that they are uniquely qualified for. While automated services are doing tasks that would otherwise be performed by humans, that does not mean these people are eliminated—it means that their role must shift.

Claudio Fayad, vice-president of Technology, Process Systems, and Solutions at Emerson, tackled this misperception in a video interview with 

“We’re not doing automation to eliminate humans—we’re eliminating human errors by upscaling them, by augmenting their capacity,” said Fayad. “As we can automate the more repetitive tasks, as we can give them a platform that is autonomous at the end but is giving them situational awareness all of the time, they are free now to look at the most important things and intervene when they need to intervene.”

Consequently, it is pivotal that humans maintain oversight over automated tasks. In terms of data integrity, automated digital tools are a fantastic tool for standardizing data collection and maintenance, but this is not a solution in of itself. There is consensus among experts that a proper data integrity process will conduct regular audits, consult with external regulatory experts, and implement crucial oversight systems operated by trained professionals; this, in turn, comes back to a proper data governance policy.

In practice, this could manifest itself as having an operator review random sections of internal log data generated by a regulatory program for inconsistencies. If there are mislabeled, incomplete, or missing logs, that operator can take the necessary actions to find out what caused it, determine what the potential impact may be, and work with colleagues to devise an appropriate solution as needed. In this sense, even though humans are not given edit access, minimizing the potential for human error, they provide oversight as a complementary force that is vital for proper software utilization. In other words, while software provides the means to data integrity, the humans interacting with it must engage in proper data governance to actualize its efforts.

“Every software platform can have different functionality and different controls, and different companies use different software in different ways,” said Wright. “Having that high-level governance strategy is your company’s commitment to how you’re going to control data within that individual software platform. It’s a starting point for the people who are going to configure and validate those systems, because they know what functionality they need to activate and what the best options are to control data.”

1. Playter, G. J&J Proposes $8.9 Billion Payment in Talc Powder Litigation.

2. BBC. Amazon Hit With $886m Fine for Alleged Data Law Breach. 

3. Shome, A. FCA Fines Santander UK £108 Million for Prolonged AML Breaches. 

4. Playter, G. Drug Digest: Unpacking the Science Behind Data Integrity.

5. Playter, G. Addressing Data Security with Claudio Fayad.

A holistic data integrity approach can help one avoid missteps in data integrity.

Common Pitfalls in Data Integrity

In this episode of the Drug Solutions podcast, Grant Playter, Associate Editor, speaks with Siegfried Schmitt, vice president, Technical at Parexel, discusses the state of biopharma investment in 2023. Topics of discussion include key areas of investment, where investment is occurring and why, and how the industry is adjusting to post-COVID regulatory and supply chain changes.

Dr. Siegfried Schmitt is a Fellow of the Royal Society of Chemistry, Chartered Chemist and Chartered Scientist. He started his career with F.Hoffmann-La Roche in Basel, Switzerland, where he worked as Senior Production Chemist in Active Pharmaceutical Ingredients and Vitamin production. Following a move to the UK, he worked for several years as consultant and validation manager for Raytheon E&C, followed by two years with ABB Eutech as Senior Lead Consultant. In 2002 Dr Schmitt joined Amersham Health (now GE Healthcare) as global Quality Assurance Director in Information Management. In July 2007 he joined PAREXEL Consulting in the UK as Principal Consultant. Dr Schmitt regularly publishes articles on scientific and business subjects, and has written several books. He speaks on a variety of topics at international conferences and industry meetings.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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In this episode, Siegfried Schmitt, vice president, Technical at Parexel, discusses the state of biopharma investment in 2023.