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

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Woman face silhouette in profile with group of multicultural and multiethnic women faces inside.Concept of racial equality anti-racism and a woman who gives voice to other women. Allyship | Image Credit: © melita – stock.adobe.com

International Women’s Day is recognized annually on March 8, providing an opportunity for all to reflect on gender diversity and seek out ways to address disparity and inequalities. For the pharmaceutical industry, the gender gap has reduced over the years, with a healthier proportion of female representation in the workforce (1)—albeit in less senior positions than their male counterparts.

In fact, according to the Deloitte Global Boardroom Program’s 

Women in the Boardroom: A Global Perspective 

report, less than a quarter of board seats worldwide are held by women (2). Narrowing down to the pharma industry and the research has found that women hold approximately 29% of executive positions and are represented in approximately 28% of corporate boards, rising slowly and steadily over the past 10 years (3).

However, better diversity and gender equality in senior, leadership positions have been shown to improve profitability and return on equity for companies through greater innovation and more creative solutions being found for problems (4). To get some insights into the ways that women can help to improve innovation within the pharma industry, 

reached out to some of the women on our Editorial Advisory Boards.

Q. How can women help improve innovation within the pharma industry?

Evonne Brennan, Consultant at Evonne Brennan Consulting:

 Women continue to empower teams in driving innovation through their own belief and/or through the strength of support through their peers. Their combination of power in bringing teams together, logical reasoning, strong driving force, and recognition of diversity generates a solid advantage on the journey to success.

Emily Heffernan, US Director New Process Technology, Arcadis U.S., Inc.:

 Women are essential to innovation in the pharmaceutical industry, bringing unique and diverse perspectives that drive scientific breakthroughs. In recent years, female scientists have been recognized with Nobel Prizes for pioneering advancements, such as CRISPR [clustered regularly interspaced short palindromic repeats] gene-editing and mRNA [messenger RNA] vaccine technology. Looking to the future, women in leadership roles can both mentor and inspire the next generation of women innovators and entrepreneurs, fostering a continuous cycle of progress and discovery.

Christa Myers, Senior Fellow–Aseptic & Sterile Products, CRB:

 The great innovators in the industry have been devoted to excellence above all. It takes effort and intention to dig past what the everyday offers.That is where innovation lies.Innovation happens when you push a solution to consider new methods, new ideas, or reuse old ideas in a new way.Women and men have to dedicate their thoughts to look for better instead of status quo in everything we do.In the pharmaceutical market—it is still true that there is a C in CGMP [current good manufacturing practice] that requires us to be ever improving, ever thoughtful, and ever reaching for higher quality, safety, and value for the patient. Innovation does not happen without intention. It takes study, curiosity, research to fuel that intention. Be ever vigilant in your daily planning to set aside time to look through different types of technology offered in ‘other’ parts of the industry to see what crossover technologies may be useful to the solution you are working on.Attend technical conferences and ask questions of component and equipment manufacturers about where they are seeing new uses for their technologies.Write down the technology and spend time later comparing the approach to different parts of the industry to tickle out where ‘else’ this technology might fit in.Stay engaged.Join membership groups and communities of practice and other thought leading groups to stay abreast of changes.Keep growing, keep chasing innovation, and keep jumping out of the status quo—it is easy to be innovative once—it is more difficult to continue to drive to innovate again and again.

Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates: 

Women have great compassion and insight which helps them relate to the patient experience. By staying in tune with their feelings, they can continue to make sure the industry continues to produce safe and effective medicines for patients.

1. Sterrett, L. Can Women Break Glass Ceilings in Healthcare/Life Sciences? Health Forward Blog. Deloitte, April 6, 2023.
2. Deloitte. Women in the Boardroom, Eight Edition. 

, March 6, 2024.
3. East Street Pharmacy. The Growing Role of Women in Pharmaceutical Leadership. 

(accessed March 6, 2025).
4. One Nucleus. Women in Pharma—Are We There Yet? 

Articles

Gender diversity and equality in leadership positions have been shown to improve profitability and return on equity through greater innovation and more creative solutions. 

International Women’s Day 2025: Improving Innovation in Industry

Feliza Mirasol is the science editor for 

The forward movement of the bio/pharmaceutical industry is driven by fast-paced advancements in manufacturing technology innovations. As manufacturing technology advances, so does the shift to continuous manufacturing (CM), a process that enables real-time monitoring, improved scalability, and enhanced quality control. As the industry increasingly adopts CM, it is undergoing a transformative shift.

In the current environment, one of the most significant applications of CM is in the production of RNA-based therapeutics, including messenger RNA (mRNA), self-amplifying RNA (saRNA), and circular RNA. In an interview with Aaron Cowley, chief scientific officer at ReciBioPharm (1), Cowley noted how industry leaders have spearheaded the development of CM platforms for RNA manufacturing with funding from FDA. These CM platforms hold the promise of significantly increasing production efficiency while maintaining rigorous quality standards.

In particular, the COVID-19 pandemic sharply highlighted the necessity of having rapid and scalable RNA manufacturing to meet global vaccine demand at the time. Traditional batch manufacturing poses bottlenecks that hinder timely drug availability. In comparison, CM integrates all unit operations into a seamless and continuous process and allows for real-time release and significant reduction in production timelines (2).

One of the key advantages of CM in RNA therapeutics is its ability to maintain small-scale yet high-throughput production. And, unlike monoclonal antibodies or conventional biologics that require thousands of liters in bioreactors, RNA production runs at much smaller scales—typically a few hundred milliliters to several liters per batch (3). CM becomes an ideal approach to tackling production of RNA-based products because it facilitates rapid adaptation and scale-up while at the same time minimizing waste and inefficiencies.

A significant innovation in CM for RNA therapeutics is the integration of in-vitro transcription (IVT) into a continuous process. Traditionally, IVT reactions are performed in batch mode, in which RNA synthesis is followed by downstream purification and formulation. But the continuous integration of IVT with purification and fill/finish operations allows for real-time monitoring and control, which leads to enhanced product consistency and yield (4).

“Being able to have eyes on the process and the product as it goes along, the full train of manufacturing, and be able to release that real time—is the overall goal that we are after,” said Cowley in the interview (1), explaining that if another pandemic comes along there won’t be a bottleneck in manufacturing, and that an RNA-based vaccine, for example, will be available and the manufacturing process will still be able to produce extra material.

On the small-molecule side, there is a trend toward higher potency and smaller dosing of APIs as, for the past 20 years, development and innovation in the pharma industry have focused on patient safety, meaning product quality, while also addressing cost efficiency and promoting greater sustainability, says Guia Bertuzzi, product manager of processing equipment for oral solid dosage (OSD) at IMA Active, the specialized division of the Italian company IMA Group.

“Modernizing the pharmaceutical industry requires both a more robust drug formulation design and better control of the production process, ensuring the highest quality and availability of the drug throughout its entire life cycle,” Bertuzzi states, adding that, “This concept strongly aligns with the adoption of the quality-by-design (QbD) approach, which prioritizes quality in drug development, as recommended by regulatory authorities. Furthermore, it paves the way for CM and other emerging technologies.”

Bertuzzi points to how CM fully supports the growing trend toward low-dose OSD forms and the increasing need for process containment and accuracy in quality control. “By definition, CM systems are designed for high-containment processes: they are typically compact, closed systems with a smaller process surface compared to batch manufacturing systems of equivalent productivity,” she explains. “Additionally, CM enables the integration of different production technologies in series, allowing for an uninterrupted material flow, from raw materials to the final pharmaceutical form, within a closed system that eliminates the need for product transfers between equipment, thereby minimizing the risk of product leakage.”

Because the CM process is continuously monitored in real-time with advanced instrumentation and an advanced control philosophy (i.e., process analytical technology [PAT]), the critical quality attributes (CQAs) of the product is also instantly monitored, allowing for increased sampling frequency without requiring physical sample collection, Bertuzzi states.

Modular and flexible manufacturing systems

The flexibility of CM, meanwhile, allows for modular process design, which enables manufacturers to switch between different modalities without major overhaul of infrastructure. The ability to switch between modalities is particularly important in RNA manufacturing as RNA therapeutics expand beyond vaccines to include gene therapies, cancer immunotherapies, and rare disease treatments. Having the ability to modify purification steps—such as adjusting the number of chromatography columns (based on impurity profiles)—will ensure that different RNA therapeutics can be produced efficiently and on a single platform (5).

However, despite the advantages that CM has demonstrated so far, the transition from traditional manufacturing to fully CM processes will continue to present challenges. Small and medium-sized enterprises (SMEs) will particularly face obstacles, including high initial investment costs, integration complexities, and the need for specialized expertise—factors that remain barriers to widespread adoption.

“Adopting CM requires a significant initial effort, including cultural and organizational changes within most pharmaceutical companies,” Bertuzzi says. “A company looking to implement CM must adequately prepare and structure itself. Beyond simply acquiring and integrating machinery in series, production and quality must be designed with a QbD approach, incorporating a higher level of automation and ensuring seamless integration between various technologies. This necessitates a strong orientation toward digitalization.”

Continuous manufacturing has gained increasing recognition by regulatory agencies such as FDA and the International Council for Harmonisation (ICH), which acknowledge CM’s potential and have issued guidelines (e.g., ICH Q13) to facilitate implementation (6).

“The drive toward CM will undoubtedly intensify due to the recent publication of regulatory guidelines (ICH Q13, FDA Q13, etc.) by major global authorities. Additionally, ongoing global challenges—such as pandemics, wars, and raw material shortages—further highlight the need for more efficient and resilient manufacturing processes,” Bertuzzi emphasizes.

Overcoming the challenges to full CM adoption will require strategic collaborations between biopharmaceutical companies, contract manufacturing organizations/contract development and manufacturing organizations, and technology providers. These collaborations will be crucial moving forward. In addition, standardization of CM technology platforms, especially those that incorporate modular automation, AI-driven process control, and cloud-based data analytics, will further enable CM adoption (7).

“From an equipment vendor’s perspective, we are actively driving the transition toward CM, particularly for SMEs, by providing process engineering support to facilitate adoption and implementation,” adds Bertuzzi.

1. Spivey, C. Biopharma’s Progress with Continuous Manufacturing in mRNA (BIO 2024). 

, Sept. 27, 2024.
2. Plumb, K. Continuous Processing in the Pharmaceutical Industry. 

 (A6), 730–738.
3. Kempf, H.; et al. RNA Manufacturing and Process Development: Current Trends and Future Outlook. 

 (10), 1168–1180.
4. Karmakar, S.; et al. Continuous Manufacturing of RNA Therapeutics: Opportunities and Challenges. 

, 107840.
4. Uhl, P.; et al. Flexible Manufacturing Strategies for RNA-Based Therapeutics. 

Guidance for Industry, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products

 (CDER, March 2023).
6. Konakovsky, S.; et al. Smart Manufacturing Approaches for Continuous Biopharmaceutical Production. 

®
Vol. 49, No. 2
March 2025
Pages: 24–26

When referring to this article, please cite it as Mirasol, F. How Continuous Manufacturing is Advancing Bio/Pharma Production. 

Continuous manufacturing offers advantages in both biotherapeutic and API manufacturing but still poses challenges.

How Continuous Manufacturing is Advancing Bio/Pharma Production

In an interview with Pharmaceutical Technology®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.

International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma

While the pharmaceutical industry has made strides towards diversity, equity, and inclusion, there is still room for improvement, asserts Sheryl Johnson, pharma application development manager at Orbia Fluor & Energy Materials. Many companies, such as Orbia, are taking proactive approaches to help improve gender diverse representations within their workforces. Ongoing commitment from all areas across the industry is required to achieve full diversity, she explains.

“Women in particular, can bring unique perspectives, talents, [and] approaches that can drive innovation, particularly in the pharma industry,” Johnson adds. “For instance, female leaders can often excel in collaborative and inclusive leadership styles, which I feel can help foster creativity and new ideas. I find women are very open to sharing of new ideas and provide supportive attitude to research management and development through considered and empathetic communication.”

Looking at sustainability challenges in particular and drawing on her experiences within the inhaled drug space, Johnson points to the groundbreaking research and leadership being performed by women helping to drive greater sustainable practices, “people like Sara Panigone from Chiesi, who's leading initiatives in developing carbon minimum inhalers and has been prominent voice in sustainability and in within the industry, and Maureen Hardwick from the International Pharmaceutical Aerosol Consortium, [who’s] been a key figure in advancing environmental policies and sustainable efforts,” she says.

“I think the future of gender diversity in the pharma industry looks promising with more women taking on leadership roles and contributing to decision making processes,” Johnson summarizes. “I think the shift will likely lead to a more inclusive, innovative approach to healthcare for inhalers and inhaled drugs, we can probably expect continued advancements in technology, in formulation and making treatments more effective, more environmentally friendly, and I think the industry is poised to make significant strides in both areas benefitting both patients and the world alike.”

Sheryl Johnson, Pharma Application Development Manager at Orbia Fluor & Energy Materials

Sheryl Johnson is Pharma Application Development Manager at Orbia Fluor & Energy Materials. Sheryl is a highly respected authority in the pharmaceutical aerosol industry with almost two decades' worth of experience in medical chemical development and research. She is on the board at the International Pharmaceutical Aerosol Consortium on Regulation & Science(IPAC RS), frequently contributed to the publishing of papers through working groups, and actively participates at industry organised conference events such as Respiratory Drug Delivery. After earning her Master's in Organic Chemistry from the University of Hull, she worked as a senior development chemist at Contract Chemicals, where she discovered her love for laboratory work. Her subsequent role at Orbia provided experience in process development, hazardous materials handling and formulation chemistry. Now, with over 13 years at Orbia Fluor & Energy Materials, she serves as Pharma Application Development Manager, overseeing the safe production and development of Zephex 152a MDIs.


Videos

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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The Munich-based contract development and manufacturing organization Adragos Pharma announced on March 6, 2025 that it has completed the installation of a new liquid filling line at a facility located in Leipzig. Germany, the site of the company’s headquarters (1).

The announcement represents the culmination of a €4 million (US$4.3 million) project intended to install and commission an advanced, current good manufacturing practice (CGMP)-compliant liquid filling line as well as an accompanying cartoning machine (1). Combined, Adragos Pharma said the new equipment would increase production capacity at the Leipzig site nearly tenfold in the face of rising demand—at a maximum of 13 million bottles per year, in various formats, to supply the pharmaceutical, cosmetic, and healthcare supplement product markets.

Two pre-existing, semi-solid commercial manufacturing lines at the 13,300-square-meter (143,160 sq. ft.) facility have been relocated to new production areas, which was the initial phase of the installation process, according to Adragos Pharma, and are now once again fully operational (1).

“This new flexible production line marks a key milestone in the development of our Leipzig site, expanding its capabilities and reinforcing our dedication to delivering state-of-the-art manufacturing solutions to our customers,” Florian Prell, site head of Adragos Leipzig, said in a company press release. “Adragos is committed to growing and investing in innovation, and we are looking forward to the opportunities and client partnerships that this project will create, as we continue to lead the industry in high-quality liquid dose form manufacturing.”

John McQuaid, president and managing director of Almac Pharma Services, summarized capacity concerns, including in fill/finish operations, 

“There's never been a larger number of molecules in clinical development, and we're certainly seeing that increasing demand,” McQuaid said in the interview (2). “We've got demand in areas such as [highly] potent [APIs], [and] age-appropriate formulations, such as pediatrics. We've got poorly soluble compounds, and the need for technologies to address that. And then we've got personalized medicines, such as, … cell and gene therapies, which drive particular needs in areas such as fill/finish and cold chain requirements.”

 its acquisition of the Swiss aseptic fill/finish manufacturing company Baccinex (3). Adragos Pharma said the transaction was made to enhance its sterile manufacturing capabilities and expand the company’s global network, leveraging Baccinex’s expertise in sterile liquids and lyophilization. Earlier that month, Adragos Pharma said it was launching a cutting-edge ampoule filling line at its Livron, France facility, enhancing its production capacity to over 160 million ampoules per year. And in April 2024, the company announced its intention to reinvest in the solid dosage market, through its plans to enhance manufacturing capacity at its plant in Kawagoe, Japan (4,5).

Meanwhile, liquid filling was one of the specializations noted by Piramal Pharma Solutions, a division of Mumbai-based Piramal Pharma Limited, 

 of a planned $80 million investment to expand a site in Lexington, Ky., for which a previous $25 million expansion had been announced in 2016 (6,7). At that facility, a new filling line, two commercial-sized lyophilizers, a capping machine, and an external vial washer are to be added by the first quarter of 2027.

1. Adragos Pharma. Adragos Pharma Completes the Installation of a New Liquid Filling Line in Leipzig, Germany. Press Release. March 6, 2025.
2. Thomas, F. 

CPHI Milan 2024: Pharma Industry Growth and Investment.

, Oct. 11, 2024.
3. Adragos Pharma. Adragos Pharma Acquires Baccinex—A Leading Swiss Sterile Fill-Finish Expert. Press Release. Nov. 25, 2024.
4. Adragos Pharma. Project Future: We Launched Our New Production Line in Our Livron Facility! Press Release, Nov. 7, 2024.
5. Adragos Pharma. Our Strategic Expansion in Japan: Reinforcing Production to 2 Billion Tablets and Aiming to be the “Most Trusted CDMO”. Press Release, April 8, 2024.
6. Piramal Pharma Solutions. Piramal Pharma Solutions Announces $80M Expansion Plan for Sterile Injectables Facility in Lexington, Kentucky. Press Release. Sept. 30, 2024.
7. Pharmaceutical Technology Editors. 

Piramal to Expand Sterile Manufacturing in Kentucky.

The €4 million (US$4.3 million) project is current good manufacturing practice compliant, and includes an accompanying cartoning machine.

Adragos Pharma Completes Liquid Filling Line Installation in Germany

On March 5, 2025, Emerson announced the release of its Rosemount 625IR Fixed Gas Detector, with the company citing a need for end users to be able to detect hydrocarbon gases quickly and reliably without false alarms (1). The detector is designed for all plant environments, utilizing advanced optical absorption detection technology.

The Rosemount 625IR model has specialized, solid-state dual infrared (IR) sources and dual IR receivers, the purpose of which are to provide continual cross-checking and make adjustments internally that hold the detector to its factory calibration (1). Emerson said advanced drift monitoring technology and health monitoring diagnostics allow the detector to be installed simply and maintain that factory standard for life—resulting in long-term reliability and minimal maintenance even in differing weather conditions and/or hazardous environments.

Accessories listed by Emerson in a press release include heaters on the optical surfaces of the detector and other protective measures that help to eliminate downtime, and mechanisms to perform function testing using either test gas or a gas-free test filter, plus ways to make the detector usable in extractive gas detection applications (1).

Emerson said duct-mounted versions are available in two lengths; these options allow for representative detection across ducts or voids that the company says is fast and accurate.

The Rosemount 625IR’s standard operating temperature range is -40 to +167 degrees Fahrenheit (-40 to +75 degrees Celsius), and it has been rated for hazardous areas throughout North America, South America, and Europe, according to Emerson (1). It has a five-year proof test interval, permitting end users to significantly reduce the frequency of scheduled maintenance visits.

Emerson, which is headquartered in St. Louis, Mo., 

 the opening of a 62,000-sq.-ft. gas analysis solutions facility in Cumbernauld, Scotland (2). The site was designed to help companies reduce their environmental impact by providing more than 10 different sensing technologies to measure more than 60 different gas components. It was also designated with the responsibility of engineering and manufacturing the Rosemount line of gas analyzers and chromatographers.

In August 2023, Emerson said it would be 

 to integrate that company’s Biostat STR Generation 3 family of bioreactors with Emerson’s DeltaV distributed control system (3). That partnership was forged with the aim of helping manufacturers build a connected plant not only through easily configurable and integrated equipment, but also increased access to advanced automation strategies and diagnostics.

® had the opportunity to sit down with Michalle Adkins, director of Life Sciences Consulting for Emerson, to discuss the structure of manufacturing organizations and how novel technologies may play a role in operations (4). The video of that interview can be accessed by clicking 

1. Emerson. Emerson’s New Fixed Point Gas Detector Provides Fast and Reliable Detection without False Alarms. Press Release. March 5, 2025.
2. Emerson. Emerson Opens Gas Analysis Solutions Center to Help Plants Meet Sustainability Goals. Press Release. Aug. 29, 2022.
3. Emerson. Sartorius Bioreactors Integrate Emerson Technology to Speed New Therapies to Market. Press Release. Aug. 3, 2023.
4. Playter, G. 

Discussing Manufacturing Operations with Michalle Adkins (Emerson Automation Exchange).

The detector features specialized, solid-state dual infrared (IR) sources and dual IR receivers which provide continual cross-checks and internal adjustments to adhere to factory calibration.

Emerson Releases Fixed Point Gas Detector Cutting Down on False Alarms

Aimee Penko is an engineering execution manager for Arcadis.

Isometric View of a Pharmaceutical Factory - Industrial Design for Prints, Cards, Posters, and Digital Graphics | Image Credit: © Anna– Stock.Adobe.com

The successful build or retrofit of a pharmaceutical facility or lab area depends on competent design deliverables. The design team is challenged with designing a facility that meets client business and regulatory requirements but also incorporates all applicable codes and standards while understanding and mitigating site constraints. Speed to market for a product is often a critical project charter that emphasizes design schedule compression, adding another challenge for the design team. All of these challenges can lead to poor quality of design deliverables if a robust quality plan is not in place.

As the industry faces increased scrutiny to bring drugs to market quicker, and at the same time reduce costs, understanding the nuances of design quality becomes paramount. This commentary is intended to be a primer for companies that are just setting off down their own design path or working with outside consultants to build or retrofit their pharmaceutical facility.

Regardless of one’s level of expertise, however, it pays to be more fully versed on the ins and outs of design quality, and the implications of paying insufficient attention to this aspect throughout the project design phase life cycle.

It’s important to understand the difference between design quality and manufacturing quality. When people in the industry hear the word “quality,” they typically think of “manufacturing quality”—the process of ensuring the product meets validated quality acceptance criteria and is thus safe to release to the public.

Design quality refers to the process of producing technically correct design deliverables that will be used to build or modify an existing pharmaceutical facility. Technical correctness is more than just individual disciplines working on their scope. Accuracy of deliverables takes into account that all scope is shown correctly, follows appropriate codes and standards, meets client requirements, and is coordinated with other disciplines to provide a design that can be constructed and validated.

Drawings should be coordinated with specifications so there is no conflict or ambiguity. Deliverables between disciplines should look uniform by following well-defined project standards. If an engineering or architectural drawing is 100% technically correct but contains multiple spelling and graphical errors, the customer (owner/client, permitting Authority Having Jurisdiction [AHJ], or constructor) may question the accuracy of the deliverable because spelling, format, title block, and revision information errors reflect poor attention to detail.

The backbone of effective design quality is a robust quality management system (QMS). A QMS provides the framework by establishing standardized processes and procedures that the design team will follow. It encompasses the procedures for the entire firm, covering all aspects of design delivery, down to seemingly mundane elements like how drawings are set up and numbered. Adherence to the QMS aligns the team on policies and procedures to streamline operations, but also enhance traceability and accountability.In addition, the QMS establishes a means for continuous improvement of deliverables and procedures through lessons learned feedback.

The QMS framework should be developed in compliance with ISO 9001, which defines the requirements for a quality management system (1). ISO 9001 is the most recognized QMS standard and the only standard within the ISO 9000 series that organizations can be certified to. The International Council for Harmonisation (ICH) Q9 Quality Risk Management guideline is another valuable reference (2). It provides guidance on managing quality risk by providing tools and principles for controlling and communicating the risk.

It’s crucial to understand that while the QMS provides a strong quality framework and documents the processes required for project review stage gates, it’s not enough. Checking a box on a checklist does not always ensure technical quality is achieved.

Technical quality is achieved by orchestrating many different types of design reviews, facilitated by experienced peers, before deliverables are issued on a project. A second set of qualified eyes helps to identify items that might have been missed by someone who has been looking at the same documents for months. This collaborative effort also fosters accountability for design outcomes, for an overall better result that directly addresses facility requirements.

Sustaining design quality throughout the project with a rigorous design review process is paramount. The reviews should happen at a frequency defined in the project execution plan, and certainly before deliverables are issued to the customer. There are multiple different types of design reviews that can be performed on a project.

 All deliverables should undergo an intra-discipline technical check.This check should be performed by a peer from that discipline that is technically competent to review the deliverables. The discipline check should involve reviewing both drawings and specifications for intra-discipline coordination between documents and technical correctness. The checker should also verify quality attributes like format, spelling, revision information, notes, etc. to ensure they are presentable to the customer.

 The squad check is an inter-disciplinary review by all disciplines on a project. It provides the opportunity to review other discipline’s deliverables to ensure scope is coordinated between the team.

For example, a mechanical engineer should review electrical drawings to ensure all mechanical equipment is powered as-specified and safely. A reflected ceiling plan (RCP) should be checked by multiple disciplines such as electrical, mechanical, fire protection, and architecture to ensure there are no clashes between lights, diffusers, sprinkler heads, and ceiling system. The squad check also provides another opportunity to ensure spelling, format, and revision information is correct on the documents. If desired, the squad check exercise participants may include external team members such as the client, construction manager, and/or sub-contractors

 Clash detection is similar in many ways to a squad check, but it’s conducted in the project three-dimensional (3D) model. Coordination software looks for clashes between (new and existing) design elements such as equipment, piping, duct, lighting, walls, and building columns just to name a few. Clashes are not always evident on two-dimensional (2D) drawings, so using 3D visualization makes them easier to identify. The clashes are published to the design team for resolution.

A Building Information Modeling (BIM) coordinator will facilitate this exercise by running the clash detection software, logging the occurrences, and expediting clash resolution between disciplines. Although no design will ever be 100% clash free, the majority of clashes should be resolved before issue, and those that aren’t reconciled shall be documented for the field team to review and mitigate before constructing in the field.

 It’s important to review and mitigate risk throughout the project. Risk assessments can take on many different forms. Initially, the project should be reviewed by leadership to make sure it’s set up for success. The review should focus on scope, project risk, budget, schedule, and execution strategy.

A risk register is another useful tool to help mitigate risk. The risk register is used to document risks identified by the team along with the resolution after discussion with the client. Late project changes are another source of possible risk and can have a cascading effect on multiple disciplines on a project.

For example, if a process change requires ethanol, the project team needs to reevaluate codes and standards to confirm if design changes are warranted. A room may require fire rated walls and a specialized fire protection system where they may not have been required (or budgeted for) previously. This type of risk could be mitigated by conducting a proper third-party peer review to provide contingency guidance to the design team. It’s vital to evaluate and mitigate risk throughout the design development to set the project up for success.

It practically goes without saying, but neglecting design quality can result in dire consequences. The most alarming outcomes include heightened construction and operational safety risk, or even outright project suspension or cancellation impacting availability of the medicines that patients are depending on.

Beyond human impact, however, the financial repercussions of poor design quality can be severe. For design firms, insufficient attention to design quality upfront may affect the bottom-line profit—or worse yet, no profit at all if substantial corrections or changes need to be made to the design after construction begins.

Poor design quality can even expose companies to regulatory actions and lawsuits. This concern cannot be overstated. If a design leads to some type of catastrophe event such as a fire, loss of life, or product recall, the company could be subject to large fines or even lose their license to practice in a particular state.

In this regard, design quality just makes good business sense for companies providing architectural and engineering services to the pharmaceutical industry. A tarnished business reputation affects client trust and loyalty, which obviously makes it difficult to attract repeat clients. In an industry where a trustworthy and honest reputation is essential, the fallout from poor design quality can be catastrophic.

So, for companies that may be embarking on a design project for the first time, what are some fundamental takeaways?

As said at the outset, design quality is inherently different from manufacturing quality. Design quality focuses on ensuring the design team provides quality deliverables that are technically correct, follow all applicable codes and standards, are well coordinated between disciplines, and can be constructed and validated.

Quality must start at the project kick-off by establishing a well-defined quality plan.The QMS provides the framework that defines the processes and procedures for achieving the design objectives and helping to shape the project quality plan. Relying on procedures and checklists alone will not guarantee quality deliverables. The design reviews must be executed by technically competent peers (or subject matter experts) to ensure the accuracy of the design.

When starting a project, one must fully understand the user (customer) requirements and project design charter. The scope of the project must be articulated to design and construction partners to ensure the project team ultimately delivers an optimal facility.

When retrofitting an operating facility, all existing drawings, current manufacturing conditions, and new facility requirements should be shared with the design team very early in the project to plan for minimal production capacity interruption. An early and comprehensive foundation of scope understanding enables an efficient and meticulously detailed project with an accelerated delivery.

Design quality is not merely a regulatory checkbox; it is a foundational element of successful pharmaceutical manufacturing design. By prioritizing a rigorous approach to design quality, companies can mitigate risks, enhance employee safety, and foster a culture of accountability and excellence.

The stakes are high, and the importance of design quality cannot be overstated. As regulatory frameworks become more stringent and the industry evolves, a commitment to design quality will not only protect lives but also safeguard the future of pharmaceutical companies.

ISO. 9001:2015 - Quality Management Systems (ISO, 2021).

ICH. ICH Q9(R1) Quality Risk Management (ICH, 2023).

®
Vol. 49, No. 2
March 2023
Pages: 28-30

When referring to this article, please cite it as Penko, A. Design Quality in Pharmaceutical Design: A Primer for Facility Executives. 

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.  

Design Quality in Pharmaceutical Design: A Primer for Facility Executives

On Feb. 28, 2025, FDA informed testosterone product sponsors of new changes to labeling, after the agency reviewed findings from a clinical trial and results from required postmarket ambulatory blood pressure (ABPM) studies (1).

The results of the clinical trial, Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE), will be added to language on all testosterone products, per FDA’s recommendation (1). “Limitation of Use” language is recommended to be retained with regard to hypogonadism—in other words, when the body’s sex glands produce an insufficient level of hormones—that is age-related, and language from the Boxed Warning pertaining to elevated risk of adverse cardiovascular outcomes is slated to be removed.

Meanwhile, data from the ABPM studies have prompted FDA to require other changes to current labeling, namely, adding product-specific information on increased blood pressure for those products that have had completed ABPM studies and a new warning about increased blood pressure for products on which such a warning does not currently appear (1).

FDA said that these labeling changes have roots as far back as 2014, when a Drug Safety Communication issued in January of that year warned of risks that had been reported of stroke, heart attack, and death, specifically, in men who had taken FDA-approved testosterone products (1). A joint meeting of the Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committee later that year resulted in the launch of the TRAVERSE trial, for which results were reported in 2023. FDA further recommended APBM studies in premarket development of subcutaneous injection and oral testosterone products in 2016 and 2017, respectively, following that with the issuing of a postmarket requirement in March 2018 that individual ABPM studies be conducted for all such products.

FDA frequently provides updates on changes to drug labels, or when those labels have been deemed to be misleading. An example of the latter occurrence happened in December 2024, when the agency 

announced Endo USA, Inc.’s voluntary recall

 of all lots of a vasoconstrictor for topical application, Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials (2). In addition to that product never having been approved by FDA, it was found to be misbranded with a misleading label similar to another FDA-approved drug made by the same company, which, in FDA’s estimation made telling the difference between the non-sterile topical product and the approved sterile injectable difficult, leading to potential administration errors.

In February 2025, Astellas Pharma said that FDA 

updated the labeling for its avacincaptad pegol intravitreal solution

 (brand name IZERVAY) by approving the drug to treat geographic atrophy secondary to age-related macular degeneration without a limitation on duration of dosing (3). That approval followed a resubmission in December 2024 of a supplemental new drug application for the solution.

 in December 2024 explaining procedures and criteria for the agency’s accelerated drug approval for serious conditions (4). Contained in that document was a stipulation that one of the conditions or requirements for accelerated approval is that “a succinct description of limitations of usefulness and anticipated benefits must be included in the drug label’s Indications and Usage section with a reference to the Clinical Trials section” (4).

In its release regarding labeling changes based on the TRAVERSE trial, FDA reminded both patients and healthcare professionals to file anyadverse events or quality issues stemming from a medication’s use to its 

MedWatch Adverse Event reporting program,

completing and submitting an online form,

 and faxing it upon completion to 1-800-FDA-0178 (1).

1. FDA. FDA Issues Class-Wide Labeling Changes for Testosterone Products. Press Release. Feb. 28, 2025.
2. FDA. Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors. Press Release. Dec. 20, 2024.
3. Astellas Pharma. US FDA Approves Expanded Label for Astellas’ IZERVAY (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Press Release. Feb. 13, 2025.
4. FDA. 

Expedited Program for Serious Conditions–Accelerated Approval of Drugs and Biologics, Guidance for Industry, Draft Guidance

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

FDA Makes Class-Wide Labeling Changes to Testosterone Products

Industry Outlook 2025: Looking at the Investment Environment

When reflecting on trends that shaped the bio/pharma industry in 2024, Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, explains that the investment environment has been his primary thought. “Investment is the oil that gets everything moving and enables us to do the process development, the work, and the product development in the end,” he says.

While investment has been tough over recent years, Forte asserts that there was a slight pick-up in activity during 2024, albeit at a slow pace. “We also saw people looking into different opportunities,” he continues, “[which] in a way is telling us that companies are finding different ways of funding so that they can continue their activities.”

Moving into 2025, Forte anticipates that industry will witness two kinds of M&A: one being activity between similar-sized companies that will combine for synergistic reasons and to optimize costs, and the other being straight acquisitions that will take a technology into Big Pharma and accelerate the development of a therapy to the patient-level. “We're going to obviously be impacted by these bigger acquisitions, because it's bigger value, and we see the value of Big Pharma really taking these products to patients,” he adds. “But in the background, there's going to be a series of smaller deals that will have that synergizing ability, bringing two companies of similar size together with broader geographic scope, broader equity story proposition, and that's what we're going to see.”

Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics

Miguel Forte is president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics—a company developing engineered cell therapies for inflammatory diseases. Miguel holds an MD and a Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a PhD in Immunology from the University of Birmingham, and a certificate on Health Technology Economics from the Stockholm School of Economics. Additionally, he is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

In an interview with Pharmaceutical Technology®, Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the M&A landscape from 2024 and his expectations of what is to come next.

Charles Ross & Son Company (Ross), of Hauppage, NY, announced in a press release on Feb. 28, 2025 a new purpose-built perfluoroalkoxy (PFA)-coated ribbon blender (1). The company said the blender has been designed specifically to meet the needs of “sensitive and challenging” applications—meaning, ones for which a stainless-steel or carbon-steel coating may not be appropriate or compatible.

Ross, founded in 1842, is a producer of industrial mixing, blending, drying, and dispersion equipment, according to the company’s website (2). Its mixers can be found in use in a wide range of industries including, but not limited to, food, cosmetics and personal care products, chemicals and pharmaceuticals, animal health products, and polymers and plastics.

In this design, a durable PFA coating, black in color, covers the interior of the trough, the double ribbon agitator, bolted stub shafts, and the funnel of the valve (1). The blender’s knife gate valve, the company said, is dust-tight, and its ease of operation ensures a smooth discharge process.

According to the press release, the coating is not available only for this model; it will be able to be optionally applied to various sizes of Ross’ ribbon and paddle blenders (1). The working capacity of the specialized PFA-coated ribbon blender is 5 cu. ft. When applied in this context, according to Ross, PFA coatings prevent product contamination and steel corrosion, promote material release, and simplify cleaning (1).

Overall, Ross said the controls of the specialized blender are operator-friendly to the extent that they feature a forward/reverse function (1). The company highlighted the equipment’s ease of use for applications such as powders, pellets, and slurries, among others.

Further information on Ross ribbon blenders can be found in the December 2024 issue of 

 In particular, the company said at that time that its Model 42N-10, among a line customized for heavy-duty and sanitary applications, is designed for free-flowing materials with bulk densities up to 100 lbs. per cu. ft.

 about its V cone blenders, which utilize diffusion as their main mixing mechanism, allowing batch materials to cascade down and distribute particles over a freshly exposed surface.

The announcement of the new blender’s specifications followed Ross’ disclosure of a price reduction (up to 40%) on its Series 100 and Series 500 Production Batch High Shear Mixers, effective in January 2025 (3).

A previous technology report from Ross on design considerations for tumble blenders was published in May 2024 and is available for download 

 Tumble blenders are effective for dry solid blends, low-viscosity slurries, and formulations of trace components that differ in size, shape, and density.

1. Charles Ross & Son Company. ROSS PFA-Coated Ribbon Blender for Sensitive Applications. Press Release. Feb. 28, 2025.
2. Charles Ross & Son Company. About Charles Ross & Son Company–Industrial Mixers Since 1842. 

 (accessed March 5, 2025).
3. Charles Ross & Son Company. Competitive Prices on ROSS Batch High Shear Mixers. Press Release. Jan. 29, 2025.

The company said this blender supports applications for which either stainless steel or carbon steel may not be suitable.

Ross Announces PFA-Coated Ribbon Blender to Be Offered for Sensitive Applications

Business cooperation strategy to create value for customers achieve the goal. | Image Credit: © Thanadon88 - stock.adobe.com

signed a six-year, $1.4 billion contract manufacturing agreement

 with an as-yet undisclosed European pharmaceutical company, with production to take place at Samsung’s manufacturing site in Songdo, South Korea (1). Simultaneously, at the J.P. Morgan Healthcare Conference held in San Francisco, the company announced plans to complete construction of its fifth biomanufacturing plant, housed on a new campus—both scheduled to open in April 2025—and said it was considering construction of a sixth plant in response to growing market demands (2).

Even with its newly minted pharma partnership in hand, Samsung said the fifth plant would raise its global biomanufacturing capacity by 180,000 L to a total of 784,000 L, and the sixth plant would push that figure to 964,000 L. Such is the crunch that companies are feeling early in 2025 when it comes to capacity concerns and drug shortages these companies are trying to quickly and efficiently address.

John McQuaid, president and managing director of Almac Pharma Services, summarized just a few of those concerns 

“There's never been a larger number of molecules in clinical development, and we're certainly seeing that increasing demand,” McQuaid said in the interview (3). “We've got demand in areas such as [highly] potent [APIs], [and] age-appropriate formulations, such as pediatrics. We've got poorly soluble compounds, and the need for technologies to address that. And then we've got personalized medicines, such as, … cell and gene therapies, which drive particular needs in areas such as fill/finish and cold chain requirements.”

McQuaid added that the rise of glucagon-like peptide-1 (GLP-1) drugs are especially driving demand and, accordingly, stress about the supply chain.

As explained by Kevin Li, MBA, chief marketing officer at BioDuro-Sundia, 

 outsourcing strategy can take one of two paths: a “traditional” approach in which a bio/pharmaceutical company splits up its program and partners with one or more contract development and manufacturing organizations (CDMOs) and a separate contract research organization (CRO), or an integrated model—which can be looked at as either horizontal, with a partner providing services from discovery to development and commercial manufacturing, or vertical, integrating medicinal chemistry, biology, and drug metabolism and pharmacokinetics starting with the discovery phase into development (4).

“One side can handle both drug substance and drug product, and one side can handle the pre-formulation, formulation development, until commercial manufacturing, everything in one side,” Li told 

®. “It's very difficult and time-consuming to manage multiple vendors, and if you do integrate the program with one vendor ... that's much easier, simpler to manage the process to avoid any potential interruptions.”

, which was fully released at CPHI Milan, suggested that 

trends may shift dramatically by the beginning of 2028

 (5). The report said contract manufacturing organizations (CMOs) and hybrid companies, which have their own pipelines and contract services for using spare capacity, will grow to hold 54% of global biologics capacity within the next three years beginning with 2025. Capacity for new clinical products entering development, according to the report, may not be easily accessible in the United States—despite capacity being available—and Europe and Asia may account for up to 75% of all CMO resources available by 2028.

“We see many more biotechs and early-stage companies now attending [CPHI Europe] to find suitable capacity—particularly for small production runs where they are more likely to partner with one of the hundreds of smaller CDMO partners. Helping find these ‘perfect fits’ is vital,” said Tara Dougal, Brand & Content director—Pharma, Informa, in a press release announcing the CPHI report (5).

The following is a brief recap of company activity announced in the fourth quarter of 2024 that illustrates some strategic responses to capacity shortage concerns both internally and between partner organizations:

In November 2024, Ascend Advanced Therapies 

announced a partnership with EW Healthcare Partners

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

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