Aligning mRNA Progress with Regulatory Streamlining

BioPharm Peer Exchange

Dosage Forms: Roundtable on Oral Solid Dosage Trends

Drug Solutions Podcast: 

Pharmaceutical packaging must advance to adapt to new, complex modalities

Out-of-the-Box Packaging Advancements

From Theory to Reality: Automating Process Development

Drug Digest: 

The Importance of Appropriate Supplier Oversight

Ask the Expert

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Rona LeBlanc-Rivera, PhD, is principal consultant, Regulatory Affairs at Regulatory Compliance Associates.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

How does FDA’s guidance, Considerations for Complying with 21 CFR 211.110, impact our current approach in complying with 21 Code of Federal Regulations (CFR) 211.110 (1)?

A: This guidance is currently in draft. However, when finalized, it will describe areas to be considered to ensure batch uniformity and drug product integrity.The guidance also discusses quality considerations for drug products manufactured using advanced in-process manufacturing techniques. Allowing flexibility to use new technological advances to determine drug product integrity and batch uniformity during manufacturing could reduce product reject rates because in-process results could be reported sooner (perhaps in-real time) and manufacturing corrections could be made to ensure the batch integrity. Drug products manufactured using advanced in-process techniques may have non-traditional quality considerations to determine the suitability of the product, and this guidance allows for flexibility and latitude on how to implement these controls effectively. It should be noted that the scope of this guidance pertains to commercial processes and not to products in development. The drug substance/API is also not within the scope of this guidance.

Q: How flexible is FDA in allowing alternative approaches to in-process controls, and what would be the process for gaining approval for such approaches?

A: FDA does allow manufacturers some flexibility to use better and more efficient methods to meet current good manufacturing practice (CGMP) requirements. It is recommended that companies gather the data and seek early FDA feedback regarding the use of alternative approaches for both in-process and quality parameters before submission of an application. Companies trying to introduce novel and new in-process test controls that yield more accurate and real-time measurements will have more success in getting approval by partnering with the FDA early in the process of introducing the new technology to the manufacturing process.

Q: What are FDA’s expectations for in-process material sampling frequency and methodology?

A: In-process sampling would be dictated by the nature of the drug and manufacturing process. It is not always feasible to obtain an in-process sample. In this guidance, FDA advises that innovative technologies may allow in-line, at-line, or on-line measurements in lieu of physical sample removal for testing.

Q: How does this guidance address the role of in-process controls in preventing drug shortages?

A: In the guideline, FDA states that it “supports the adoption of advanced manufacturing as a foundation for improving the overall quality and availability of drug products for patients.” Exploring how to improve manufacturing oversight through the use of the innovative technologies mentioned above could help enhance supply chain stability and eliminate some drug shortages. Advanced in-process and quality parameter controls may help reduce production failures that contribute to these shortages.

Q: If a more efficient in-process control method could reduce shortages but it is not covered in the guidance, how should companies seek FDA approval?

A: For an FDA-approved drug product, the application holder should gather the necessary data and documentation for filing a supplement (i.e., CBE [changes being effected]-30, PAS [prior approval supplement]) to their application regarding the use of alternative approaches. FDA would then review and provide comments on the proposed change and help identifying the best pathway forward for regulatory acceptance of innovative manufacturing techniques.

This new guidance offers flexibility to manufacturers, including contract manufacturing organizations, to introduce new, more efficient methodologies to measure batch uniformity and product integrity required to determine product suitability to ensure continued access to necessary pharmaceutical products. It is up to pharmaceutical industry to work with FDA and determine the best implementation strategy for realizing the benefits of modernizing manufacturing processes.

Considerations for Complying with 21 CFR 211.110, Draft Guidance

Susan J. Schniepp, is distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, is principal consultant, Regulatory Affairs at Regulatory Compliance Associates.

When referring to this article, please cite it as Schniepp, S.J. and LeBlanc-Rivera, R. Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance. 

Articles

Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Feliza Mirasol is the science editor for 

Discussion with Chris Murphy of Environmental Specialties about the design and critical role or walk-in chambers in bio/pharma development and manufacturing.

INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing

Walk-in chambers are critical infrastructure in pharmaceutical facilities, primarily used for product storage under highly controlled environmental conditions, such as temperature and/or humidity, says Christopher Murphy, director, Global Business Development and Service Customer Support, Environmental Specialties. Murphy sat down with the PharmTech Group at INTERPHEX 2025 to discuss the role walk-in chambers play in bio/pharmaceutical development and manufacturing as well as sustainability.

Given the stringent requirements of pharmaceutical products, these chambers are often large-scale, resembling warehouses. However, their energy-intensive nature poses sustainability challenges.

“Proper design of a walk-in chamber can contribute to sustainable practices. It is no secret that a walk-in room, because of the exacting conditions it has to create, can be an energy hog. It can be a drain on utilities. But if properly designed, and if the manufacturer asks the correct questions about the use of the space, then it can be engineered in a way that minimizes that impact and runs at optimum performance,” Murphy says.

As Murphy explains, proper engineering and design can mitigate energy consumption, optimize performance, and extend the chamber’s operational lifespan, thereby reducing maintenance costs and environmental impact. He also points out that thoughtful construction minimizes the need for frequent replacements and spare parts, promoting long-term sustainability.

Meanwhile, Murphy remarks that the current market dynamics and economic conditions influence investment in such technologies, raising questions about whether the observed market fluctuations are temporary or indicative of long-term trends. At INTERPHEX 2025, he is keen to explore strategic partnerships with emerging companies because such partnerships can facilitate knowledge exchange and help stakeholders align technological capabilities with market needs. Murphy emphasizes that the industry must balance precision storage requirements with sustainability and economic considerations to ensure long-term operational efficiency and environmental responsibility.

Attendees can visit Environmental Specialties at Booth #2864 at INTERPHEX 2025, which runs April 1–3 in New York City.

Christopher Murphy, Director, Global Business Development & Service Customer Support, Environmental Specialties

Christopher Murphy currently serves Environmental Specialties as director of global business development and service customer support. For the past 12 years, he has been vice-president or president of companies serving regulated markets. He has a proven track record of driving double-digit annual sales growth. In his previous role, he joined a company that had been flat for the decade prior to his arrival and was able to generate a 23% compound annual growth rate over his four-and-a-half-year tenure, doubling the company’s revenue. Prior to that, he achieved title of president while leading growth from $2 million to $50 million in annual sales. Murphy has been responsible for the launch of numerous innovative products, including being a co-author of a patent for a predictive maintenance technology related to components within medical diagnostic Instruments in his most recent role. Murphy has extensive experience in global business, having managed teams in China, led distributors and agents across Asia and Europe, and performing business development efforts, including mergers and acquisitions, globally.

Sitting down with the PharmTech Group at INTERPHEX 2025, Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, discusses the design and critical role of walk-in chambers in the bio/pharmaceutical industry.

INTERPHEX 2025: Continuous and Controlled Freeze-Drying

Regulatory uncertainty has been a challenge to the implementation of continuous freeze-drying in the pharmaceutical industry, according to Thomas De Beer, co-founder and CEO of RheaVita. “The pharmaceutical industry is highly regulated, which makes it pretty difficult to innovate—[maybe] not difficult, but it makes it slow to innovate, especially new manufacturing technologies,” De Beer says in an interview with Pharmaceutical Technology® Group at INTERPHEX 2025. “And along with that, let's say, regulatory uncertainty. You also have the mindset of people within the pharmaceutical industry, they know that there is regulatory uncertainty to innovate, so their mindset is a bit oriented to that regulatory hesitance. However, on the other hand, there are also opportunities.”

The highly regulated nature of the pharma industry may make it difficult to innovate; however, regulators can often be the instigation for innovation. “They published several guidelines on process analytics and process analytical technology, but also on continuous manufacturing,” De Beer says. “And you see that this indeed stimulated the industry to innovate in pharmaceutical manufacturing, to leave the conventional batch wise manufacturing approach and to focus on continuous manufacturing. And at the same time, you see also new types of drug products coming up. And these new types of drug products, they become more and more complex. They require more flexible manufacturing. This also helps to stimulate innovation.”

RheaVita is exhibiting at Stand 2967 at INTERPHEX 2025, which is being held in New York City from April 1–3. De Beer's presentation, "

Revolutionizing Pharma: Continuous Manufacturing and GMP-Ready Freeze-Drying for Scaled Innovation

" is scheduled for Thursday, April 3 at 9:15AM.

Click the video above to watch the interview.

Thomas De Beer, co-founder and CEO of RheaVita

Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a process analytical technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark, Department of Pharmaceutics and Analytical Chemistry (Prof. Jukka Rantanen). After his PhD, he was an FWO-funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked nine months at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics from the Ludwig-Maximilians-University in Munich, Germany (Prof. Winter and Prof. Frieβ). In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing, etc.). More specifically, De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals (continuous freeze-drying of unit doses). De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which was founded in 2016. In 2018, De Beer became co-founder and CEO at RheaVita, which provides a continuous freeze-drying technology for the pharmaceutical market.

Videos

Pharmaceutical Technology® Group sat down with Thomas De Beer, co-founder and CEO of RheaVita, to talk about his presentation at INTERPHEX 2025, “GMP-ready Continuous & Controlled Pharmaceutical Freeze-Drying”.

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

: Behind the Headlines Episode 14–Investment Trends, Policy Realignments, and Vaccines

Behind the Headlines is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 14, panelists Christian Cobaugh, PhD, CSO and founder of Vernal Biosciences; Eswar Iyer, PhD, co-founder and CSO, Aikium Inc., and Vincenzo Antignani, PhD, Technical training lead, Asahi Kasei Bioprocess America, Inc., adjunct facility Northeastern University & Governing Committee (GC) Member, NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals, discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old. 

Performance advances in both China and India have led to renewed investments from other countries into both infrastructure and licensing agreements. Novo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion (1). In addition, AstraZeneca is committing up to $11 billion to Chinese Collaborations including a Beijing R&D Hub (2).

Changing skills requirements for future workforce in a time of turmoil was a major consideration for the panel, appearing and reappearing throughout the conversation. It included the re-folding of recently fired National Institutes of Health workers, as Robert F. Kennedy, Jr. pursues his plans to slash the Department of Health and Human Services’ workforce by 25%, implement massive reorganization, and consolidate authorities, creating a new agency for a ‘Healthy America’ (3).

Conversation also turned to attitudes toward messenger RNA, as the United States outlines plans to end vaccine funds for poor countries, in parallel to several other efforts to frame vaccines as just-one-choice-among-many-options, to discuss with one’s healthcare provider (4).

Lastly, 23andMe’s future in bankruptcy protection after having held, at its highest, a market valuation of $6 billion dollars, was bruited about. The panel also examined the company’s chances of legally selling customer genomic data as a lift raft, and also, what the demise of such a pioneering company means in the overall commercial landscape at this time.

Click the video above to watch the discussion.

1. Sunny, M. Novo Bets on 'Triple G' Obesity Drug in up to $2 billion Deal with Chinese Biotech. 

https://finance.yahoo.com/news/novo-licenses-chinese-biotechs-obesity-102141800.html

2. Philippidis, A. AstraZeneza Commits Up to $11B+ to Chinese Collaborations, Beijing R&D Hub, 

Genetic Engineering and Biotechnology News

https://www.genengnews.com/topics/drug-discovery/astrazeneza-commits-up-to-11b-to-chinese-collaborations-beijing-rd-hub

3 Owermohle, S.; Lawrence, L.; and Bannow, T. RFK Jr. Plans to Slash HHS Workforce by 25% in Massive Reorganization. 

https://www.statnews.com/2025/03/27/rfk-jr-10000-job-cuts-hhs-restructuring-health-agency-impacts-cdc-fdaG-nih-cms

4Kirchgaessner, S.; Glenza, J. Trump Administration at ‘War’ with mRNA Technology: Scientists Alarmed Vaccine Skeptics Could Kill Research. 

https://www.theguardian.com/us-news/2025/mar/27/trump-vaccine-skeptics-research-funding

5. Satija, B.; Shah, A.; Misra, S. DNA Testing Firm 23andMe Files for Bankruptcy as Demand Dries Up. 

https://www.reuters.com/business/healthcare-pharmaceuticals/dna-testing-firm-23andme-files-chapter-11-bankruptcy-sell-itself-2025-03-24/

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old. 

Behind the Headlines Episode 14–Investment Trends, Policy Realignments, and Vaccines

INTERPHEX 2025: AI and Automation in Pharma

Automation is being utilized in the areas of quality, throughput, and operator autonomy within the pharmaceutical industry, according to Peter Sarvey, head of Sales for Automation NTH, and the cost of using automation has decreased in the past two years. Meanwhile, the accuracy of these tools is increasing.

The use of artificial intelligence (AI), which has been used in the “vision side” of automation according to Sarvey, is also increasingly starting to be used in the inspection side of manufacturing.

“When we have a lot of part variation, we're not just programming pick and place, or motion based on preset points. So, we move to an area, and then we use the AI vision to tell us, where is that exact part or how much has that part changed? So, it actually allows the automation to move more seamlessly,” Sarvey says. “And then the other side of that is on the inspection side of things. There are a lot of inspections that previously were done manually, because it's not a simple pattern match for if this medical device or this pharmaceutical component is a reject. Now we can teach the AI what a good part looks like, what a bad part looks like, and then over time, shift that area too, all in the nature of increasing throughput and decreasing yield loss.”

® Group spoke with Peter Sarvey at INTERPHEX 2025, which is being held in New York City from April 1–3. Automation NTH can be found at Stand 3061.

Peter Sarvey is Head of Sales for Automation NTH, a specialist in semi-automated and fully automated solutions for a broad array of manufacturing applications, including pharmaceuticals and medical device production. With a focus on next-gen robotics and controls, the company’s services include custom automation, equipment optimization and automation consulting. 

Pharmaceutical Technology® Group spoke with Peter Sarvey, head of Sales for Automation NTH, at INTERPHEX 2025 about the growing use of automation and artificial intelligence in the pharmaceutical industry.

INTERPHEX 2025: Automation for Protein Manufacturing

Biomanufacturing involves complex operations and thousands of skilled workers, says Kerry Love, co-founder and CEO of Sunflower Therapeutics, a biotech company specializing in continuous and fully integrated equipment for the production of proteins. Automation can be a way to build quality and reduce human errors, while also allowing workers who might not be as skilled to participate in high-value manufacturing.

“When you use automation in general, you kind of make something that's usually highly complex, with a lot of handoffs and transitions, much less complicated, particularly in continuous bioprocessing," Love says in the interview. "That's actually a great place for automation, because already you're simplifying unit operations and making interfaces between unit operations that oftentimes haven't been there in the past. That's a great way to then layer automation on top of that and ultimately get to walk away solutions like those that we build at Sunflower.”

® Group spoke with Love at INTERPHEX 2025, being held April 1–3 in New York City. Sunflower Therapeutics can be found at Stand 1273.

Kerry Love, co-founder and CEO of Sunflower Therapeutics

Kerry Love, PhD, is the co-founder and CEO of Sunflower Therapeutics, a women-owned and led biotechnology company delivering next-generation protein manufacturing solutions that anyone can use to create innovative new medicines, vaccines, foods, and other bio-produced materials. Love is an organic chemist by training, performing her doctoral studies at MIT, and a biotech entrepreneur at heart, having founded two companies and contributed to the starting of many more over the past 20 years.Love has authored more than 40 scientific papers and patents.

The Pharmaceutical Technology® Group spoke with Kerry Love, co-founder and CEO of Sunflower Therapeutics at INTERPHEX 2025, to find out how automation enhances the manufacture of proteins.

TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com

FDA announced on April 1, 2025 that Martin A. Makary, MD, has been sworn in as the agency’s new commission after a bipartisan confirmation by the US Senate. Makary, a graduate of Bucknell University, Thomas Jefferson University, and the Harvard School of Public Health, completed his residency at Georgetown University and surgical oncology fellowship at Johns Hopkins.

He founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and led cross-disciplinary research on cancer, obesity, Alzheimer’s, adverse event monitoring, and antimicrobial resistance. He is a member of the National Academy of Medicine and co-developer of the Surgery Checklist.

“I am honored and humbled to assume this role at the FDA under the leadership of President Trump and Secretary Kennedy,” said FDA Commissioner Martin A. Makary, in the press release (1). “I look forward to working with this Administration and the FDA workforce to advance our shared goals in meeting the agency’s public health mission. As Commissioner, I hope to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense so that we can Make America Healthy Again.”

“I am pleased to welcome Dr. Makary to the U.S. Department of Health and Human Services and the Food and Drug Administration,” said HHS Secretary Robert F. Kennedy, Jr., in the release. “He is a national leader in medicine with impeccable credentials. His extensive research, clinical experience, and national leadership make him uniquely qualified to lead the FDA as we work together to Make America Healthy Again.”

Back in January 2025, FDA leaders, Commissioner Robert Califf and the Director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, resigned their posts (2–4). And in March 2025, Peter Marks, director of the Center for Biologics Evaluation and Research resigned (5).

Califf warned of misinformation on his way out of office. "We are currently losing the battle due to the intersection of social media and cultural changes, which threatens the foundation of public health," Califf said. “A lot of people died who would not have died if they had gotten a free vaccine and not been misled [about the safety of vaccines]” (3).

The concern over misinformation was also on the mind of Marks, who stated the following in his resignation letter (6):

“Over the past 13 years, I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said. “As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

1. FDA. Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner. Press Release. April 1, 2025.
2. Herper, M. Leaving FDA, Califf is Unapologetic—and Warns of Staff Departures. 

. Jan. 8, 2025.
3. Eglovitch, J. S. Goodbye Message: Califf Says FDA Needs Help in Battling Misinformation, Has Deep Talent Pool to Mitigate Departures. 

. Jan. 17, 2025.
4. Haigney, S. Cavazzoni Retires as CDER Director. 

https://www.pharmtech.com/view/cavazzoni-retires-as-cder-director


5. Haigney, S. FDA CBER Director Peter Marks Resigns. 

. March 31, 2025.
6. Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by 

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Martin A. Makary Becomes New FDA Commissioner

INTERPHEX 2025 video interview with Iwata Label USA discussing practical security benefits of functional labels for parenteral drugs.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes

Sitting down with the PharmTech Group at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, a division of Japan-based IL Group, highlights the need for improved protection of pharmaceutical vials and syringes, particularly through functional labels. Previously, vials were not sufficiently protected due to cost considerations, but after conducting recent studies, the company began to understand the financial and human costs of breakage. Instead of overhauling packaging, however, Wainwright asserts that functional labels can reinforce existing vial infrastructure by preventing breakage, cracks, and leaks.

“We traditionally have not protected the vials as stringently as we should and could, just simply for cost reasons. It's just now that we've done more studies on the costs associated with broken vials, or even the human cost of negative effects to healthcare workers, [that] the need for heightened protection on vials has increased,” Wainwright says in the interview. “And then with functional labels, what they can do is, instead of reimagining the whole packaging system, you can use existing packaging infrastructure, [such as] the traditional vials, but then add on a specialty label that helps protect the vial from breakage, cracks, or seepage of the internal contents.”

He goes on to explain that, for syringes, the primary concern is material-induced drug migration, which can alter the chemical composition of highly potent medications. Preventing migration is critical to maintaining drug integrity. Another key function of these labels is shielding vial and syringe contents from light exposure, which can degrade pharmaceutical compounds. Functional labels, therefore, serve a dual purpose: physical protection and preservation of drug stability.

Wainwright also expresses enthusiasm for engaging with industry leaders at INTERPHEX 2025 to encourage broader adoption of these specialized labeling solutions within the pharmaceutical sector.

Attendees can visit Iwata Label USA at Booth #1362 at INTERPHEX, which is being held on April 1–3 in New York City.

William Wainwright, Business Development Manager, Iwata Label USA, a division of IL Group

William Wainwright is business development manager for Iwata Label USA, a division of IL Group, and a provider of precision labeling solutions for global pharmaceutical and healthcare companies. The company’s portfolio includes good manufacturing practice-compliant roll-on and shrink-tack labels featuring value-added benefits, such as tamper evidence, protection against breakage, and light-shielding properties, as well as specialty constructions whose functions range from reliable adhesion in cryogenic applications to detachable elements for ease of medical recordkeeping.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

AES Clean Technology (AES), a provider of modular cleanroom solutions, announced on April 1, 2025 that it has officially launched Omni ASCENT, a next-generation off-site manufactured (OSM) vertical utility solution that is designed to optimize the flexibility and efficiency of cleanrooms, at INTERPHEX 2025. The company said in a press release that the launch of this OSM solution is a significant advancement toward cleanroom utility integration (1). INTERPHEX is being held on April 1–3 in New York City.

Omni ASCENT is built on the foundation of AES’s Omni utility raceway, which is a system that integrates critical cleanroom utilities into a modular, adaptable framework. Omni ASCENT enables strategic placement of utilities anywhere on the cleanroom floor. In comparison, traditional systems limit layout options and pose challenges to accessibility, according to AES in the press release. Omni ASCENT enables greater flexibility, efficiency, and safety, and allows pharmaceutical and biotech facilities to optimize space and workflow without having to compromise compliance, according to the company.

“Omni ASCENT is a direct response to the evolving needs of modern cleanroom environments,” said Shawn Reniker, senior vice-president of Operations, AES Clean Technology, in the release (1). “By eliminating the need for wall or ceiling-mounted utilities, we are giving manufacturers the freedom to configure layouts more efficiently, enhance accessibility for maintenance and operations, and accelerate deployment—all while maintaining the highest industry standards.”

Omni ASCENT is designed for rapid deployment; it arrives fully assembled and ready for installation, which can be done in under half a day. This shortened deployment significantly reduces downtime. Meanwhile, its strategic utility placement enhances ergonomics while creating a safer workspace by eliminating unnecessary ladder use and tripping hazards. In addition, the new system can be easily integrated with existing Omni raceway solutions. This compatibility facilitates a streamlined transition for both new cleanroom builds and facility retrofits, according to the press release.

“Last year, the CleanLock Module reinforced the demand for smarter, more flexible cleanroom solutions. Omni ASCENT builds on that momentum, providing even greater adaptability in utility integration and ensuring that facilities can scale efficiently without redesigning their infrastructure,” said Chris Miller, chief executive officer, AES Clean Technology, in the release.

 the CleanLock Module, which is an airlock solution for cleanrooms that has been engineered to minimize the risk of contamination. The module minimizes contamination risk by integrating AES’ proprietary cleanroom finishes, patented lighting, predictable airflow patterns, and advanced door controls. These features offer the advantage of being integrated into any facility without delay. The module allows for secure transition of people and materials entering and exiting cleanrooms.

"We are thrilled to introduce the CleanLock Module airlock to the market," said Grant Merrill, AES chief commercial officer, in a press release at the time of the CleanLock Module launch in 2024 (2). "This product addresses the critical need for maintaining ultra-clean environments in industries such as pharmaceuticals, biotechnology, and medical device manufacturing. With its state-of-the-art technology and precision engineering, the CleanLock Module will set a new standard for contamination control and efficiency in design and construction execution."

Attendees can visit AES at Booth #2509 at INTERPHEX 2025.

1. AES Clean Technology. AES Cleanroom Technology Introduces Omni ASCENT: A Breakthrough in Cleanroom Utility Integration at INTERPHEX 2025. 

. April 1, 2025.
2. AES Clean Technology. AES Clean Technology Sets New Standards for Cleanliness and Efficiency in Cleanrooms with the Launch of Its CleanLock Module. Press Release. April 16, 2024.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

AES Clean Technology Introduces OSM Cleanroom Utility Solution at INTERPHEX 2025

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

Culture Biosciences, headquartered in South San Francisco, Calif., is announcing the launch of Stratyx 250, which the company said in a press release is the first mobile, cloud-integrated bioreactor that is designed to provide biotech companies with simultaneous flexibility, automation, and remote process control (1).

The launch coincides with the start of the 2025 INTERPHEX conference in New York City, which runs from April 1–3, 2025.

Culture Biosciences defines cloud-based bioprocessing as the integration of physical bioreactors with remote data monitoring, automation, and artificial intelligence (AI)-driven optimization (1). The company has designed Stratyx 250 to allow researchers to leverage its Culture Console software for remote tracking and adjusting of parameters in real time.

The end results, according to Culture Biosciences in the press release, include reduction of errors, improved reproducibility, and greater precision and efficiency (1). This is especially important, the company said, considering that biotech companies are generating massive amounts of process data given the rise in high-throughput experimental methods, but may lack the ability to efficiently derive actionable insights from that data.

“The biotech and biopharmaceutical market segments are experiencing a major shift toward cloud-powered, modular bioprocessing, and these companies need hardware and software that can keep up,” said Chris Williams, CEO of Culture Biosciences, in the release (1). “With a five-month ROI [return on investment] timeline and a plug-and-play scalable architecture, our platform offers a cost-effective, flexible alternative to traditional bioreactors—helping companies accelerate development and reduce costs without compromising on quality.”

According to the press release, Stratyx 250 affords users a 16% lower total cost per run versus traditional benchtop bioreactors, development timelines that are faster by up to 25%, and a 30% improvement in scale-up success (1).

In discussing its offering of an “early adopter” program for select customers, Culture Biosciences provided the perspective of Jondavid De Jong, PhD, vice president of Scientific Operations for Virica Biotech.

“Stratyx 250 is already reshaping how we approach process development,” De Jong said (1). “The ability to remotely monitor and adjust experiments in real time is streamlining our workflows and improving reproducibility across runs. The combination of cloud integration, automation, and mobility makes it a game-changer for modern bioprocessing.”

®, Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products, said that 

automation has been playing a larger role

 in advancing equipment that supports bioprocessing, highlighting digital twin technology, integrated control systems, automated sampling and analysis, and smart bioreactors as some of the developments being witnessed in the biomanufacturing space—including at the commercial level (2).

“From what our team has seen, most commercial biomanufacturing processes are partially automated, with automation implemented in upstream (e.g., bioreactors, feeding systems) and downstream (e.g., chromatography, filtration) steps,” Christopher said, qualifying that manual intervention is needed for setup, troubleshooting, and quality control, but that many facilities now use automated systems for data collection, process monitoring, and quality assurance (2).

Culture Biosciences said Stratyx 250 is currently being demonstrated at its South San Francisco facility (1). The company can also be found at Booth #3417 at INTERPHEX, being held at the Javits Center in New York City.

1. Culture Biosciences. Culture Biosciences Unveils Stratyx 250, the First Cloud-Integrated, Mobile Bioreactor for Cell Culture Process Development. Press Release. April 1, 2025.
2. Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.

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