Susan Haigney

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Nelson Labs announced on Aug. 26, 2025 that it is expanding its state-of-the-art laboratory space at its Wiesbaden, Germany facility (1). The expansion comes as a response to what the company says is a growing demand for packaging and microbiological testing. The company provides microbiological testing, analytical chemistry testing, and advisory services to the pharmaceutical industry.

The Wiesbaden facility offers end-to-end sterility assurance services, including Sterigenics sterilization. Sterigenics, A Sotera Health company, is a provider of outsourced terminal sterilization and irradiation services for a variety of industries.

What new services will the expansion provide?

The investment will enhance the site’s packaging validation and microbiological testing capabilities for medical device and pharmaceutical customers. The facility will be fully operational throughout the expansion. Included in the expansion are four new laboratories for packaging testing services that will enhance current microbiological testing capacity. These labs will be able to perform endotoxin, bioburden, ethylene oxide residual testing, and biological indicator sterility testing. Packaging integrity services will also be introduced. A full suite of packaging testing services will include strength testing, integrity testing, container closure integrity testing, microbial barrier testing, aging studies, and distribution testing. Improvements will also be made to bioburden testing, featuring separate sample, personnel entry points and high efficiency particulate air (HEPA)-filtered air systems to ensure contamination control.

In June 2025, Nelson Labs announced an expansion at its Salt Lake City headquarters to double the lab’s existing ISO-certified cleanroom capacity to support sterility assurance testing and align with the European Union’s good manufacturing practice requirements (2). Enhancements to the Salt Lake facility include a new isolator suite, zoned HEPA filtration, and upgraded laminar airflow systems.

Nelson Labs has more than 3000 customers and 12 facilities in the United States, Mexico, Asia, and Europe with more than 900 laboratory tests. Additionally, Regulatory Compliance Associates, a Nelson Labs company, provides regulatory consulting services.

®’s Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, moderates a discussion between Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each (3).

Specifically, Christiaens and Jenke highlight the differences between the E and the L in E&L and how these two compounds play off each other. Jenke goes into detail about the requirements for leachable studies, while Christiaens provides clarification on what is necessary for extractables.

The episode is available on Aug. 28, 2025. Visit PharmTech.com to watch the discussion. 

https://www.pharmtech.com/view/ask-the-expert-studies-for-extractables-and-leachables

Nelson Labs. Nelson Labs Expands Laboratory Capacity and Services in Wiesbaden, Germany to Meet Growing Demand for Packaging and Microbiological Testing. Press Release. Aug. 27, 2025.

Nelson Labs. Nelson Labs to Double Cleanroom Capacity to Support Growing Demand for Sterility Assurance Services. Press Release. June 11, 2025.

Schniepp, S. and Haigney, S. Ask the Expert: Studies for Extractables and Leachables. 

Articles

Nelson Labs is expanding its Wiesbaden, Germany facility to meet increasing demand for packaging and microbiological testing. The expansion includes four new laboratories for packaging testing services, enhancing microbiological testing capacity with endotoxin, bioburden, ethylene oxide residual, and biological indicator sterility testing. Packaging integrity services will also be introduced. Concurrently, Nelson Labs is doubling its cleanroom capacity at its Salt Lake City headquarters to support sterility assurance testing. Additionally, a discussion on extractables and leachables testing is featured in Pharmaceutical Technology®’s Ask the Expert video series.

The laboratory services provider is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility.  

Nelson Labs Expands Laboratory Capacity and Services at German Facility

The Impact of FDA’s Guidance on Clinical Trials for Radiopharmaceuticals

On Aug. 18, 2025, FDA published a draft guidance, titled 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

, that was created to assist drug sponsors with identifying an optimized dosage for radiopharmaceutical therapies for cancer indications during clinical development (1). The guidance addresses clinical development before submitting a marketing application for a new indication and usage.

® spoke with Michael Ritchie, chief commercial officer of Champions Oncology, to find out how the new guidance might impact the development and approval of radiopharmaceuticals and what some of the challenges are for conducting clinical trials for these treatments.

“Radio pharmaceuticals have been around for about 100 years, and classical radiopharma relied on something called EBRT, or external beam radiotherapy, and that is essentially delivering a radio beam to the patient from an external source,” Ritchie says. “But we're now looking at a new wave of therapies which are injected systemically, and quite frankly, we just don't know enough about them. FDA has released new guidance that has said, hey, we want you to come to the table with a better understanding of pharmacodynamics potential liabilities from a toxicity perspective, therapeutic window. But we also want you to design your clinical trials in such a way that we can get an idea on dosimetry.”

Click the video above to watch the full interview.

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. Draft Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development

Videos

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, may impact the development of radiopharmaceuticals as cancer treatments, Pharmaceutical Technology® spoke with Michael Ritchie, chief commercial officer of Champions Oncology. 

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

On Aug. 21, 2025, Johnson & Johnson (J&J) announced it will be adding a more than 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC. This will be part of a $2 billion expansion during the next 10 years to expand J&J’s manufacturing capacity in the United States. The facility will focus on the manufacture of advanced medicines. The company stated it also has plans for adding more advanced manufacturing facilities in the US and expanding current US facilities.

“Johnson & Johnson has more manufacturing facilities in the US than in any other country, and we continue to strengthen our presence here,” said Joaquin Duato, chairman and chief executive officer, Johnson & Johnson, in a press release (1). “With the recent signing of the One Big Beautiful Bill Act, we continue to expand our investment in the US to lead the next era of healthcare innovation.”

In March 2025, J&J announced the investment of $55 billion in US manufacturing, R&D, and technology over the next four years, including the following:

Construction of a facility in Wilson, NC, that will employ more than 500 people when fully operational and create approximately 5000 construction jobs during the site development

R&D infrastructure to develop lifesaving and life-changing treatments in areas such as oncology, neuroscience, immunology, cardiovascular disease, and robotic surgery.

“Today’s announcements accelerate our nearly 140-year legacy as an American innovation engine tackling the world’s toughest healthcare challenges,” Duato said in a press release at the time (2). “Our increased US investment begins with the ground-breaking of a high-tech facility in North Carolina that will not only add US-based jobs but manufacture cutting-edge medicines to treat patients in America and around the world.”

In early August 2025, J&J was one of the companies on the receiving end of letters sent by the Trump administration insisting prescription drug prices be lowered in the US. In what has been called a most-favored-nation price strategy, the White House has been in talks with pharmaceutical companies about ways drug pricing can be reduced (3).

The ongoing tariff situation has also been making impacts in the pharmaceutical industry.

® reached out to readers to find out how the tariffs may have impacted those working in the industry. A survey found that tariff-driven costs are rising, and the supply is strained, with nearly half of respondents reporting that the tariffs will ‘significantly’ impact their operations or the supply chain (4).

Other companies making an investment in the US

J&J isn’t the only pharmaceutical company making an investment in US facilities. On Aug. 13, 2025, AbbVie announced it was expanding US API production with a $195 million investment in a manufacturing plant in North Chicago, Ill., allowing the company to deepen its chemical synthesis capabilities in the US (5).

Bora Pharmaceuticals also announced an investment in August. The company will be expanding manufacturing and packaging capability at its Maple Grove, Minn. facility (6). In July, AstraZeneca announced a $50 billion investment in manufacturing and R&D US facilities by 2030 (7). And in June 2025, Hikma Pharmaceuticals announced it was putting $1 billion into expanding generic-drug R&D and manufacturing in Ohio and New Jersey (8).

J&J. Johnson & Johnson Continues U.S. Investment with $2 Billion Commitment to Enable Manufacturing at State-Of-The-Art North Carolina Facility. Press Release. Aug. 21, 2025. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-continues-u-s-investment-with-2-billion-commitment-to-enable-manufacturing-at-state-of-the-art-north-carolina-facility

J&J. Johnson & Johnson Increases US Investment to More than $55 Billion Over the Next Four Years. Press Release. March 21, 2025.

Lavery, P. Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol. PharmTech.com. Aug. 1, 2025. 

https://www.pharmtech.com/view/trump-sends-letters-17-leading-pharma-companies-outlining-most-favored-nation-drug-pricing-protocol

Cole, C. Bio/Pharma’s Tariff Response: Key Insights from Industry Survey Results. PharmTech.com. Aug. 20, 2025. 

https://www.pharmtech.com/view/biopharma-pharmaceutical-industry-tariff-response-key-insights-from-industry-survey-results

AbbVie Announces $195 Million Investment to Expand Active Pharmaceutical Ingredient Manufacturing in the US.

Bora Pharmaceuticals Announces Multi-Year Expansion for Midwest Manufacturing Site, as Upsher-Smith Entity Split is Finalized.

AstraZeneca Plans to Invest $50 Billion in America for Medicines Manufacturing and R&D.

Hikma Pharmaceuticals USA Announces $1 Billion of New US Investment to Further Expand its Domestic Manufacturing and Development of Essential Generic Medicines.

Johnson & Johnson is investing $2 billion over the next decade to expand its US manufacturing capacity, starting with a new facility in North Carolina. This is part of a broader $55 billion investment in US manufacturing, R&D, and technology announced in March 2025. The expansion aims to enhance the production of advanced medicines and create significant employment opportunities. Concurrently, the Trump administration is pressuring pharmaceutical companies to lower drug prices. Other companies, including AbbVie and AstraZeneca, are also making substantial investments in US facilities.

The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

Johnson & Johnson Invests $2 Billion into North Carolina Facility

The Impact of Reclassifying 7-OH Products

issued an emergency rule filing to classify certain 7-hydroxymitragynine (7-OH) products as Schedule 1 controlled substances in Florida, making it illegal to sell, possess, or distribute certain 7-OH drugs in the state (1). This action follows 

to control concentrated 7-OH products under the Controlled Substances Act. Those recommendations now head to the Drug Enforcement Agency for review (2).

To find out how these government actions may impact the pharmaceutical industry, 

, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council. White sees the actions as helping pharmaceutical manufacturers combat those companies wishing to circumvent regulations.

“Pharmaceutical companies have to spend a billion or more dollars in order to be able to bring their drugs to market and have to be able to prove the benefits and the risks of those products. Here, you don't have to do any of that. All you have to do is take a product, put it in a well-marketed form, and then just put it out on the shelves and see what happens. And that's not a good way to be able to have a healthcare system,” White says. “So, I think [FDA’s and Florida’s decision] is going to be good, because it helps to underscore that there should be one way that these chemicals are coming out onto the market and that it's the same level playing field for everyone.”

Click the video above to watch the interview.

Makary, M.A. Statement from FDA Commissioner Marty Makary, MD, MPH, on Florida Restriction of 7-OH Opioid Products. 

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products

FDA. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. Press Release. July 29, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers

C. Michael White is Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy. He is also the Chair of the Kratom Consumer Advisory Council. He has been a clinical pharmacology and evidence synthesist researcher for more than 27 years and focuses on reducing drug, dietary supplement, device, and procedure-induced diseases.

Pharmaceutical Technology® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council, about recent government actions regarding kratom and concentrated 7-hydroxymitragynine (7-OH) products.

Mitragyna speciosa or kratom leaves with medicinal products in capsules and powder in white ceramic bowl and wooden table, top view | Image Credit: ©Yanawut Suntornkij - stock.adobe.com

 for the control of concentrated 7-hydroxymitragynine (7-OH) products under the Controlled Substances Act (1), because a concentrated byproduct of the kratom plant has been recognized as having the potential for abuse due to its ability to bind to opioid receptors. The agency also released a report, “7-Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat,” detailing concerns over these products. FDA’s recommendations now go to the Drug Enforcement Agency, which has authority over drug classification.

On Aug. 14, 2025, Florida Attorney General James Uthmeier 

issued an emergency rule filing to classify certain 7-OH products as Schedule 1 

controlled substances in Florida. The rule makes it illegal to sell, possess, or distribute certain 7-OH drugs in the state (2).

, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council, to find out how these regulatory actions may impact the pharmaceutical industry and consumers.

 Can you please explain what kratom is and how it is used in the development of opioids?

 tree in Southeast Asia that was called kratom by indigenous people when Western explorers arrived in the 1800s. The leaves contain many phytochemical alkaloids that can act on receptors in the body. Mitragynine is the most abundant alkaloid and stimulates serotonin, alpha-1 and alpha-2 adrenoceptors, and indirectly and mildly stimulates opioid receptors. Mitragynine is a unique opioid receptor stimulator because it is a mild stimulator rather than a depressant and is unlikely to cause reductions in respiratory rate or minute ventilation as the dose escalates. One of the metabolites of mitragynine is 7-OH, which is a very potent but short-acting opioid receptor stimulator, and the metabolite of 7-OH is mitragynine pseudoindoxyl, which is also a potent opioid receptor stimulator but possibly with a longer duration of action.

Instead of following the normal process where chemicals derived from natural products are pre-clinically tested to support an IND [investigational new drug] application followed by Phase I, II, and III clinical trials, manufacturers simply extracted mitragynine, oxidized it to make 7-OH, and then chemically converted it to make mitragynine pseudoindoxyl. [They] started putting it into products and selling it to consumers with no involvement of health professionals.

Consumers could self-select if they wanted to take it, even if it was just to experience euphoria, choose the duration of therapy, and choose their own dose. This seems to be against FDA’s drug approval process and sets a horrible precedent for drug development. These products were never approved as new dietary ingredients and should not have been legally sold as dietary supplements, but they were.

While 7-OH is found in trace amounts (less than 2% of total alkaloids) in the dried kratom powder, it is not in the fresh leaf, so whether it would qualify as a dietary supplement is unclear. However, it is clear that mitragynine pseudoindoxyl is not found in fresh or dried kratom leaves and should never be allowed as a dietary supplement.

[This situation] is similar to the recent sales of tianeptine as a dietary supplement. Tianeptine is a fully synthetic molecule and used as a drug in some European countries but appeared on gas station, convenience store, and smoke shop shelves as a dietary supplement. This exposes a major vulnerability in our drug and dietary supplement market where dietary supplements do not need to notify FDA before they are sold, and it is up to the overworked and understaffed FDA to discover them and then start testing, warning, and enforcement actions. Additionally, 7-OH products are actually being sold in vape pens, sublingual strips, and buccal pouches even though dietary supplements can only be swallowed. This is blatant disregarding of federal law.

 How do the recommendations by FDA, and Florida’s emergency ruling to reclass certain concentration 7-OH opioids as controlled substances, impact the pharmaceutical industry, patients, and consumers?

 The actions from FDA and [the] Florida Attorney General are desperately needed by the pharmaceutical industry, patients, and consumers. Pharmaceutical companies following FDA guidance and spending billions of dollars to bring a drug to market that is proven to have a positive benefit-to-risk profile in human clinical trials should not be competing against competitors that are circumventing the process and directly reaching consumers. Patients are being denied access to well-tested, novel drugs because prescribers cannot be certain if the risks of these new products are better or worse than current options, how to use the drugs in unique patient types, and what the risk of drug interactions are. Consumers are taking products that animal studies show are highly addictive with no protections. Many of the products are being sold next to the Gatorade and Mentos and are fruit-flavored, sugar-enhanced candy formulations with names that would appeal to children or drug seekers.

 What actions will pharmaceutical companies need to take to respond to the new regulations?

 I hope that pharmaceutical companies would become more aware of competitors that are cutting corners and directly reaching consumers with their drug products or are selling dietary supplements in ways that are clearly illegal but compete with prescription products (like natural GLP-1s given in transdermal patches). These are not counterfeit drug makers, which pharmaceutical companies are adept at combatting; but companies selling products for the same indications but are unique chemical entities, or are using legal loopholes like saying they are ‘peptide’ companies to sell counterfeit versions of drugs to consumers, pretending that they are only selling them for ‘research purposes.’ Another great example is people selling THC [tetrahydrocannabinol], used to help people sleep, reduce stress, etc., but use a loophole in the Farm Bill to create THC and THC-like chemicals from extracts of ‘hemp’ cannabis plants. FDA does not have the bandwidth to combat these entities unless this type of enforcement becomes prioritized.

The FDA has recommended controlling concentrated 7-hydroxymitragynine (7-OH) products under the Controlled Substances Act due to their potential for abuse, as they bind to opioid receptors. Florida has classified certain 7-OH products as Schedule 1 controlled substances, making their sale, possession, or distribution illegal. These regulatory actions aim to protect consumers and the pharmaceutical industry from unapproved products that bypass FDA's drug approval process. The pharmaceutical industry must remain vigilant against competitors exploiting legal loopholes to market unapproved or potentially harmful products.

FDA’s recommendation to control 7-OH products under the Controlled Substances Act should help prevent competition between legitimate pharmaceutical medicines and those companies looking to circumvent FDA regulations, says Michael White, Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and Chair of the Kratom Consumer Advisory Council.

Kratom and the Impact of 7-OH Reclassification

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA published a draft guidance document on Aug. 18, 2025 titled 

 that was created to assist drug sponsors with identifying an optimized dosage for radiopharmaceutical therapies (RPTs) for oncology indications during clinical development. The guidance addresses clinical development before submitting a marketing application for a new indication and usage. The new draft guidance should be used alongside recommendations provided in the August 2024 guidance, 

Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.

The new draft guidance, however, does not cover selection of the initial RPT administered activity in first-in-human trials. Other aspects of clinical development of RPTs, such as dosimetry software, fixed administered activity dosing for a population versus dosing determined by personalized dosimetry, and theranostic co-development, are not addressed in the guidance document.

According to the FDA guidance document, RPTs share characteristics with external beam radiation therapy (EBRT) and systemic drug therapy. RPTs adhere to absorbed dose limits to critical organs determined by prior experience with EBRT. FDA states, however, that the differences between RPTs and EBRT in physical properties and treatment delivery lessen the applicability of EBRT-derived organ absorbed dose limits to RPTs. The optimized RPT dosage, therefore, may be greater than or less than a dosage limited by EBRT organ tolerances. Radiation absorbed dose limits also may differ between different isotopes or RPTs based on their physical properties. “Empiric determination of RPT-specific organ tolerances, or full assessment of dose-response relationships for a specific RPT, may not be possible if the evaluated dosages are limited based on EBRT organ tolerances,” the guidance document states (1).

The new draft guidance provides considerations for dosage optimization. According to the document, if there is adequate rationale that the optimized dose of an RPT cannot be identified at lower dosages, administered activities per cycle and/or cumulative RPT-administered activities that result in absorbed dosages exceeding EBRT organ tolerances can be studied in clinical trials of RPTs.

“Proposals to expose participants to RPT dosages that exceed EBRT organ tolerances or previously characterized RPT dosages could be justified based on existing clinical data or other approaches, as applicable, and should be discussed with FDA during formal meetings, including early in clinical development,” the agency states in the document (1). “Trials should include safeguards such as appropriate participant selection, trial design, safety monitoring, and radiation dosimetry evaluation.”

The guidance goes on the discuss participant population, trial design, safety monitoring, and dosimetry for dosage optimization trials.

Mike Ritchie, chief commercial officer at Champions Oncology, radiopharmaceuticals

 have been used in the past to treat superficial tumors, but they have evolved to treat internal tumors as well (2).

“There's so much [that goes] into pharmaceutical development into making something that can be manufactured at scale. It can sit on a shelf for a while. We can administer it to a patient, and it behaves in the way that we want,” Ritchie said in an interview with 

®. “We're just learning how to apply what we learn from anybody drug conjugates into radio drug conjugates, so the chemistry of how to link this radio ligand to an antibody, something that will continue to evolve, and there's a real opportunity there to improve that, to improve the therapeutic activity. From the biology perspective, again, we're in our infancy and understanding what are the tumor types, or the molecular cohorts within a tumor that are more sensitive to radio ligands. Like any chemotherapy or any therapy, certain tumors will respond. Others will not. They'll develop resistance. And so really understanding the right cohorts of patients to treat is something that we're still learning, and I think we'll continue to learn as the clinical development of these programs evolves.”

PharmTech’s interview with Mike Ritchie can be found 

Haigney, S. The Evolving Field of Radiopharmaceuticals. 

https://www.pharmtech.com/view/the-evolving-field-of-radiopharmaceuticals

The FDA's draft guidance document, released in August 2025, aims to assist drug sponsors in optimizing dosages for radiopharmaceutical therapies (RPTs) in oncology during clinical development. It emphasizes dosage optimization before marketing applications and should be used alongside the 2024 guidance on oncologic drug dosage. The guidance does not cover initial RPT dosages in first-in-human trials or other clinical development aspects like dosimetry software. It highlights the differences between RPTs and external beam radiation therapy (EBRT) and suggests that optimized RPT dosages may exceed EBRT organ tolerances.

The guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for cancer treatment during clinical development. 