Feliza Mirasol is the science editor for 

Feliza Mirasol

Lonza announced on Sept. 24, 2024 that it has entered into a long-term commercial supply agreement with Vertex Pharmaceuticals under which it will manufacture Casgevy (exagamglogene autotemcel), the first clustered regularly interspaced short palindromic repeats (CRISPR)/ CRISPR-associated protein 9 (Cas9)-gene-edited cell therapy for treating sickle cell disease (SCD) and β thalassemia.

Under the agreement, Vertex will have access to Lonza’s scientific, regulatory, and manufacturing expertise as well as its global manufacturing network and its experience in the commercial manufacture of cell therapy products. Lonza plans to manufacture Casgevy at its cell therapy manufacturing facilities in Geleen, the Netherlands, with plans to expand to its Portsmouth, NH manufacturing facility in the United States.

“It is a privilege to work with Vertex on bringing its innovative and cutting-edge medicines to patients suffering from life-threatening diseases. We are also pleased to reach a significant milestone towards supporting the commercial manufacture of Casgevy by receiving the regulatory approval at our state-of-the-art cell therapy manufacturing site in Geleen,” said Daniel Palmacci, president, Cell & Gene, Lonza, in a company press release.

The Geleen facility recently received a good manufacturing practice (GMP) license from FDA, the European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Lonza expects the Portsmouth site to begin GMP operations in 2025.

“Manufacturing a first-of-its-kind therapy [such as] Casgevy is complex and requires advanced technology and capabilities. The Lonza team have been excellent partners as we have invested in our global manufacturing network to ensure Casgevy will be available for the patients who need it. We look forward to our continued collaboration,” said Morrey Atkinson, PhD, executive vice-president and chief technical operations officer, head of Biopharmaceutical Sciences and Manufacturing Operations, Vertex, in the press release.

Casgevy was approved by the MHRA in November 2023 (1), by FDA in December 2023 (2), and by EMA in February 2024 (3). Following the MHRA and FDA approvals in late 2023, Vertex 

, a UK-based cell and gene therapy contract development and manufacturing organization, in December 2023 (4) to manufacture Casgevy. RoslinCT runs manufacturing facilities in Edinburgh, Scotland, and Boston, Mass., which are purpose-built for cell therapy products. The CDMO had been working with Vertex on an adaptive basis while Vertex moved through clinical and regulatory development of Casgevy.

1. Vertex Pharmaceuticals. Vertex and CRISPR Therapeutics Announce Authorization of the First CRISPR/Cas9 Gene-Edited Therapy, Casgevy (exagamglogene autotemcel), by the United Kingdom MHRA for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia. Press Release, Nov. 16, 2023.
2. FDA. 

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

. Press Release, Dec. 8, 2023.
3. Vertex Pharmaceuticals. European Commission Approves First CRISPR/Cas9 Gene-Edited Therapy, Casgevy (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia. Press Release. Feb. 13, 2024.
4. RoslinCT. RoslinCT to Manufacture First-Ever US FDA Approved CRISPR-Based Gene Therapy Casgevy (exagamglogene autotemcel). Press Release. Dec. 11, 2023.

Articles

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

Lonza and Vertex Enter Commercial Supply Agreement for CASGEVY, the Sickle Cell Disease Gene-Edited Cell Therapy

With FDA's approved of Eli Lilly and Company’s (Lilly’s) EBGLYSS (lebrikizumab-lbkz), a targeted interleukin 13 (IL-13) inhibitor, a new biologic treatment is made available for moderate-to-severe atopic dermatitis (eczema) in adults and children 12 years of age and older. The treatment is applicable to patients who weigh at least 88 pounds (40 kg) and whose moderate-to-severe atopic dermatitis is not well controlled with topical prescription therapies.

FDA’s approval was based on results from several studies (ADvocate 1, ADvocate 2, and ADhere). These studies included more than 1000 adults and children (aged 12 and older) with moderate-to-severe eczema whose symptoms were not controlled with topical prescription medicines. At 16 weeks, the primary endpoint for these studies was evaluated; measurements showed clear or almost clear skin, according to the company press release.

"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, MD, PhD, professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, and first author of the 

 manuscript summarizing EBGLYSS clinical trials (1), in a company press release. "[FDA’s] approval of EBGLYSS is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough."

Averaging two of the studies (ADvocate 1 and 2), it was shown that 38% of people who underwent the treatment achieved clear or almost-clear skin at 16 weeks, compared to 12% with placebo. Ten percent saw the same results in as early as four weeks. Many responders also experienced itch relief in both studies with the treatment. On average, 43% felt itch relief at 16 weeks, compared to 12% on the placebo. Five percent of people felt relief as early as two weeks.

"Eczema can affect people of all skin tones, ethnicities, genders, and ages. Nearly 16.5 million adults in the [United States] have eczema, with 6.6 million experiencing moderate-to-severe symptoms [such as] itchiness, dry and scaly skin, discoloration, and rashes, which can lead to more scratching that may cause skin to crack and bleed, (2)” said Kristin Belleson, president and CEO of the National Eczema Association, in the release. "The approval of EBGLYSS provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."

"People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives," said Daniel Skovronsky, MD, PhD, chief scientific officer and president of Lilly Research Laboratories, and president, Lilly Immunology, in the release. "Today's approval allows people the opportunity to reimagine life with eczema as EBGLYSS offers a targeted approach to reduce a main cause of eczema inflammation. EBGLYSS provides long-lasting symptom relief with a convenient once-monthly maintenance dose."

EBGLYSS was also approved in Europe by the European Commission in 2023 and in Japan in January 2024. Additional market approvals are expected later this year.

Lilly has exclusive rights for the development and commercialization of EBGLYSS in the US and the rest of the world outside Europe. Almirall, Lilly's partner, has licensed the rights to develop and commercialize the biologic for treating dermatology indications, including eczema, in Europe.

1. Silverberg, J. I.; Guttman-Yassky, E.; Thaçi, D.; et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. 

 (12),1080–1091. DOI: 10.1056/NEJMoa2206714
2. Chiesa Fuxench, Z. C.; Block, J. K.; Boguniewicz, M.; et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. 

 (3), 583–590. DOI: 10.1016/j.jid.2018.08.028

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.

Lilly’s EBGLYSS Offers New First-Line Biologic Treatment for Atopic Dermatitis Following FDA Approval

Eli Lilly and Company is enhancing its global biopharmaceutical production with an added $1 billion expansion of its manufacturing site in Limerick, Ireland. The company announced the increased investment on Sept. 12, 2024. With the new investment, Lilly will increase production of biologic active ingredients at the site, including the biologic active ingredients for Kisunla (donanemab-azbt), the company's therapy for treating early symptomatic Alzheimer's disease 

The company also unveiled its new $800 million facility expansion in Kinsale, Ireland. The Kinsale facility began operations in 2023 and produces Lilly's latest diabetes and obesity treatments in response to market demand, according to a company press release.

The additional $1 billion investment in Limerick, on top of the $800 million investment in Kinsale, is part of the company’s goal to raise its manufacturing footprint. Lilly has committed more than $20 billion since 2020 into building, expanding, and acquiring manufacturing facilities in both the United States and Europe, the company stated in the release.

"These investments will boost the production of some of our medicines, helping millions of people with diabetes, obesity, and Alzheimer's disease live the healthiest lives possible," said Edgardo Hernandez, executive vice-president and president of Lilly Manufacturing Operations, in the release. "We won't stop there—these state-of-the-art facilities will also be equipped to support our promising pipeline molecules of the future."

Once completed, the Limerick site will become a part of Lilly's global manufacturing network for the production of the biologic active ingredients for the company's Alzheimer's disease portfolio as well as other biologics.

"Alzheimer's disease is a devastating diagnosis for both the patient and for their loved ones, along with having a huge burden on society," said Anne E. White, executive vice-president and president of Lilly Neuroscience, in the release. "The treatments we will make here in Limerick offer the potential to be able to slow the progression of the disease and make life better for millions of people around the world."

The new $1 billion investment brings Lilly’s total investment in Limerick to $2 billion, which is double the amount the company initially announced in March 2023. The site will include advanced technologies such as machine learning, artificial intelligence, and automated robotics and systems to enable right-first-time execution. Lilly plans to create another 150 jobs for highly skilled workers in Limerick, including positions for engineers, scientists, quality assurance professionals, and operations personnel, bringing the total staff at the site to 450 employees. Lilly broke ground on the Limerick site in March 2023, following its initial announcement for the new facility in 2022. The company anticipates production of biologic active ingredients to start up in 2026.

Meanwhile, the new Kinsale site will serve the company’s production of diabetes and obesity therapies. The site uses a digital-first process that integrates continuous manufacturing technology for creating a new manufacturing platform for complex peptides.

FDA Approves Treatment for Adults with Alzheimer’s Disease

Lilly has added a $1 billion investment to increase biologics manufacturing at its Limerick, Ireland, site while unveiling its new $800 million facility in Kinsale.

Lilly’s $1.8 Billion Biologics Expansion Expected to Grow Manufacturing Footprint in Ireland

On Sept. 9, 2024, Sartorius announced the launch of its Vivaflow SU tangential flow filtration (TFF) cassette. The Vivaflow SU is designed to be more user-friendly and to allow for more flexibility in laboratory workflows. The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes in the range of 100 mL–1000 mL.

According to a company press release, the new all-in-one cassette reduces cost and complexity and streamlines workflows for molecule isolation in a sustainable manner. Each cassette is ready to use and has a standard laboratory pump, which enables simple set-up. The simplified set-up avoids the need for expensive systems and expensive process optimization and allows for faster and more reliable concentration and rebuffering of any molecule. The cassette also eliminates the need for cleaning and reduces contamination risk while minimizing waste, according to the press release.

“Vivaflow SU is a testament to our promise to always simplify progress,” said John Cashman, product manager for Lab Ultrafiltration at Sartorius, in the press release. “It takes the ease-of-use that our customers already value about TFF with Vivaflow and elevates the experience with improved handling and performance, while reducing waste. Our next-generation cassette eliminates the need for feed flow rate, TMP [transmembrane pressure], and permeate flux calculations, while also offering sustainability improvements that are truly impressive for a single-use consumable.”

Sustainability features of the new cassette include a new housing that uses 30.5% less plastic. It also incorporates several eco-friendly design improvements, such as locally sourced raw materials, customized tubing kits for each cassette configuration, a digital user manual, and reduced non-recyclable packaging; all these design elements contribute to a lower research footprint, the company stated in the press release.

Vivaflow SU is the-next-generation TFF cassette that replaces the previous Vivaflow 50. It is meant for research scientists who require a fast and reliable means for concentrating and rebuffering large feed volumes in molecule isolation workflows.

The launch of Vivaflow SU follows on the heels of Sartorius’ earlier launch of the Arium Mini Extend water purification system for laboratories in June 2024 (1). The Arium Mini Extend is the newest member of the Arium Mini product line. The new purification system is designed to meet the Type 1 water demands of laboratories for general, life-science, and analytical applications, according to the company in a press release. The new system is compact and offers ultrapure water purification with flexibility and convenience.

The new system comprises a flexible, ergonomic handheld dispenser, a user-friendly digital display, and the Arium Bagtank technology to significantly optimize laboratory workflows. The dispensing unit is equipped with an independent volume control function and expands the access area for ultrapure water. The new system streamlines water purification processes, especially those processes that require repeated dispensing. Meanwhile, operation and maintenance have been made simpler with intuitive menus and a 5-L Bagtank for storage of purified water. These features facilitate cleaning procedures and ensure uninterrupted laboratory workflows, the company stated in its press release.

1. Sartorius. Sartorius Launches New Arium Mini Extend with Flexible Arm for Versatile Type 1 Water Dispensing. Press Release. June 17, 2024.

Sartorius' new Vivaflow SU tangential flow filtration cassette offers better flexibility in lab workflows and is designed to be more user-friendly. 

Sartorius Introduces New TFF Cassette that Offers Streamlined Workflow in the Lab

On Sept. 6, 2024, CPHI Milan announced the finalists for the 2024 CPHI Pharma Awards. The ceremony will be held on the event’s opening evening at the CPHI Celebration. CPHI Milan will run October 8–10, 2024. 

A key feature of the CPHI Celebration, the awards ceremony spans 14 categories and celebrates excellence and innovation in the pharmaceutical industry. The 2024 awards highlight two new categories: a new "Woman of the Year" award and a new "Future Leader" award.

Editor's note: this story was edited on Sept. 18, 2024 to update the “Accelerating Innovation” award category.

The Woman of the Year award honors women leaders who inspire colleagues, champion diversity and inclusion, and advocate for industry progression. Nominees are evaluated based on leadership ability, collaboration skills, and ability to create opportunities for women while challenging the status quo. The Future Leader award recognizes rising stars who are under 35 years of age and who have at least five years of experience in pharma, biopharma, or academic institutions. The award commends those who bring fresh perspectives to the table, manage teams effectively, and introduce innovative ideas. The winners of this award are marked as the future leaders who are anticipated to shape the pharmaceutical industry with dedication and vision.

The shortlist for this year’s awards includes the following:

ProPharma Group/PBL for the Cell Factory Box (CF Box)

Haemopharm Healthcare s.r.l for RIGENERA, an innovative tissue regenerating technology

Akums Drugs and Pharmaceuticals for hydroxyurea oral suspension, the first room temperature-stable drug, according to CPHI’s press release

Merck/Millipore Sigma for the Benzonase Salt Tolerant endonuclease and Emprove Expert raw and starting materials chemical portfolio

AustinPx for its KinetiSol Technology, used for improving bioavailability of poorly soluble drugs

Single Use Support for the RoSS.FILL CGT, a fully automated filling and filtration system that enables automated aliquoting of small volumes at highest accuracy

Thermo Fisher Scientific for leveraging artificial intelligence (AI) to accelerate clinical trials for large pharma

Blynksolve for the Blynksolve Digital Knowledge Twin

Ministry of Industry and Mineral Resources, Kingdom of Saudi Arabia for its Pharmaceutical Industrial Strategy Acceleration Process.

Dr. Reddy’s Laboratories for its development of a drug substance process using flow chemistry and design of a continuous manufacturing plant

Teva api for the Ozonolysis in Flow, a green and safe alternative to heavy metal-catalyzed cleavage of the carbon–carbon double bond on an industrial scale

LEON and Team Consulting for the NANOme Benchtop system, used for personalized therapies

Enzymaster for (S)-4-phenyl-oxazolidinone

Lonza for the Lonza AI-Enabled Route Scouting Service.

Thermo Fisher Scientific for its efforts in revolutionizing vaccine logistics, shelf-life, and wastage with fridge-free innovation

Unistraw Corp. for the UniLayer Straw Delivery System

Lonza for Capsugel Enprotect Size 9 capsule for pre-clinical studies

Lubrizol Life Science Health (LLS Health) for Apinovex Polymers, used for enhancing oral solubility.

Axom Solution SA for its Automated Visual Inspection Station

FABRX for its Revolutionising Care for Children: Personalized 3D Printed Medicines

Teva api for its Advanced AI Optimization for API Production

RheaVita for the RheaLyo GMP-Flex continuous freeze-dryer

Catalent Cell & Gene Therapy for the UpTempo CAR-T Cell Therapy Platform Process.

Azelis Group NV, for its novel bioadhesive oral fluid gel spray

Adare Pharma Solutions for its sprinkle formulation of a drug capsule used for treating tremors and other uncontrolled body movements

Aptar Pharma and Haleon for Otrivin Nasal Mist, a first next-generation nasal congestion device transforming experience, adherence, and effectiveness

ApiJect Syestems for its Prefilled ApiJect Injector

CurTec International for CurTec Fold Pack Pails

Colorcon for EQIUS Equilibrium RH Stabilizers

WestRock for the Cere Screen Digital Display Label

Esmark Finch for the Digital Carton Workflow for pharmaceutical cartons.

TraceLink for its Multienterprise Information Network Tower(MINT)

QYOBO GmbH for a new age of supply chain visibility and resilience

HCLTech for the HCLTech Smart Material Tracking Solution

I.E. Medica Inc. for E-Z Philippine Importation.

Nordic Bioproducts Group Ltd for Pioneering Sustainable Microcrystalline Cellulose (MCC) Production, a first-of-its-kind production facility powered by patented AaltoCell technology in Lappeenranta, Finland

Rotor Print for From Rigid Packaging to Flexible Packaging

Berry Global for its Clarified PP VMS kit

PharmaBlock Sciences for Innovation for Sustainability: Pioneering Low-carbon Manufacturing with Continuous Flow Chemistry Technology

Evonik Industries AG for its PhytoSquene plant-based squalene for parenteral applications.

RTIXIO LIFESCIENCES PVT LTD for Dvarka, a regulatory driven, AI, and automation-assisted platform for emerging market access and compliance

Eidolon Learning Pvt Ltd for SEEK, an AI-driven tool for reducing human error

ProPharma Group for Prodigy, an end-to-end technology-enabled consulting platform

ASPHALION, S.L. for its Regulatory, Scientific & Safety Consulting in Life Sciences service

Esteve Quimica for the Volta Project: who said impossible?

Vijay Ambati, Founder and CEO, Clearsynth

Nebu-Flow Nebuliser Platform by Acu-Flow Limited (t/a Nebu-Flow)

Galvita TIP, a new standard of oral drug delivery by Galvita AG.

Cipla Limited for Drone Powered Delivery for Critical Patient Care

Honey Farm, ICAS Employee Support; Deniz Kayadalen Brand Ambassador, Woodland Trust, Adalvo

Fox Chase Cancer Center and West Pharmaceutical Services, West Pharmaceutical Services.

Sigma Mostafa, PhD, Chief Scientific Officer, KBI Biopharma

Almuth Steinkühler, PhD, Chief Financial Officer, SCHOTT Pharma AG & Co. KGaA

Julia Tsetis, President and CEO, OFET group of pharmaceutical companies

Audrey Butler, Vice President, Global Operational Excellence, Adare Pharma Solutions

Neeti Pant, Managing Director & Co-Founder, DDReg Pharma Pvt Ltd

The 2024 CPHI Pharma Awards comprise finalists spanning 14 categories and includes awards for future leaders, women of the year, and an “at the heart of pharma” category.

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Adventitious agent testing remains critical in biomanufacturing to help ensure product purity. As such, testing protocols from monoclonal antibody (mAb) manufacturing may be transferred to gene therapy manufacturing, as the optimization of testing practices are applicable to gene therapy manufacture. 

Editor’s note: this article was published in 

For instance, in conducting tests to confirm a biological product’s safety, it is necessary to use multiple assays to ensure that various contaminants are identified. Several assays are commonly used in combination to test for adventitious agents, which is required by regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency. The two main types of assays for identifying adventitious agents are 

 assays are utilized when mammalian cell lines are used to produce biopharmaceuticals, while 

 tests to detect viruses that are not able to be grown in cell culture (1). 

Of more immediate concern is the fact that more complex modalities of biopharmaceuticals are prevalent in the industry pipeline. These complex modalities typically require more complex manufacturing processes, which means each product in development is a more significant investment of time and energy as well as patient trust. The current climate makes thorough biosafety testing procedures more crucial for biopharma developers (2).

Adventitious agents comprise a broad range of contaminants, which are unintentionally introduced into the biomanufacturing process. These agents include bacteria, fungi, viruses, mycoplasma, parasites, and mycobacteria, among others. A common way that adventitious agents enter the biomanufacturing process is via starting materials that are animal or human origin. These materials include cell substrates, bovine serum, or the cell lines themselves, or may be introduced by the manufacturing operators, such as where manual handling or processes are concerned (2).

Inadequately tested biopharma products that end up with contamination run the risk of investigation, corrective action, and downtime in manufacturing that ultimately costs the manufacturer—and developer—millions of dollars or more. Therefore, having preventative strategies and comprehensive testing in place is imperative in biologics manufacturing. Another issue to consider is that contamination can happen at any point in the process between securing the cell bank to the fill/finish stages. To mitigate contamination risk and ensure efficient workflow, it is necessary to test for adventitious agents at multiple timepoints. It is also worth it to note that testing and detecting any contamination earlier in the manufacturing workflow, rather than just relying on testing prior to final product release, can better ensure that tainted product does not reach the market and can save time, cost, and effort (2).

For virus detection, methods include traditional culture-based methods as well as electron microscopy studies, 

 molecular and antibody assays, sequencing methods such as massive parallel or next-generation sequencing, and degenerate polymerase chain reaction (PCR). Methods for detecting bacteria also include culture-based approaches and PCR but can also employ biosensor-based methods. Meanwhile, for other adventitious agents such as mycoplasma, detection can include PCR—this includes specific PCR kits, microbiological culture methods, and enzyme-linked immunosorbent assays (3).

Similarly, the adventitious agent testing requirements for viral vectors are consistent with the requirements for other modalities of biotherapeutic products, including selection of appropriate testing methods. However, a direct transfer of testing strategies used in recombinant proteins and mAbs may not necessarily be feasible or practical for viral vectors. Biological differences between viral vectors and large-molecule proteins hinder direct adoption of testing strategies (4).

Because viral vectors are themselves viruses, standard assays may need to be modified or alternative methods used for testing them. That factor can interfere with virus detection methods during adventitious agent testing. Other complications arise if cell-based assays are used to test live-virus vaccines, replication-competent gene therapy vectors, or vectors that exhibit the cytopathic effect. The issue stems from the fact that human cell lines are primarily used to develop cell-based assays, which are susceptible to human viruses. Adenoviral products, which are lytic viruses, will, for example, infect both human and primate-derived cell lines, which would invalidate the assay. On top of that, there is always the risk that cellular toxicity may occur (4).

If adventitious agents are detected, an important step is to identify the species and the origin(s) of the contamination. It is then important to evaluate the agents’ potential to infect humans (5). Some adventitious agents still find their way into the end product despite extensive detection efforts. Examples of these occurrences include the presence of porcine circovirus 1 found in a commercial rotavirus vaccine and a novel rhabdovirus in a Spodoptera frugiperda (Sf9) cell line (6–8).

 adventitious agent testing methods are usually sufficient, but they have their limitations. For one thing, test sensitivity may not be high enough to detect certain contaminants or too-low concentrations of contaminants. Some assays require lengthy times to perform. What’s more, different testing methods inherently have different sensitivities for detecting different contaminants, and each method has its own limitations. Fortunately, these different methods can complement each other and, when combined, can offer greater understanding of detecting adventitious agents (4).

The delivery times for some adventitious virus test results can be challenging, regardless of which testing methods are used. Some assays may take several weeks to generate results. On top of that, certain biotherapeutics, such as gene therapies, have short shelf lives, so waiting on results for adventitious agent testing may come too late. This is a concern for autologous cell therapies that are dependent on gene-modified components and must be administered to the patient soon after they are produced (4).

On the positive side, detection technologies for adventitious agent testing continue to evolve, with a focus on higher sensitivity, rapid methods, and broad detection ranges. The downside is that new technologies take time to develop, and they must be thoroughly validated to demonstrate their suitability and applicability before the bio/pharma industry and regulatory bodies will accept them for implementation into the testing strategies for adventitious agent control in biomanufacturing (9).

 (accessed 10 July 2024).
2. Thermo Fisher Scientific. Improving Adventitious Agent Testing in Biologics Manufacturing. 

, 9 Feb. 2023 (accessed 10 July 2024).
3. Morris, C.; Lee, Y. S.; Yoon, S. Adventitious Agent Detection Methods in Bio-Pharmaceutical Applications with a Focus on Viruses, Bacteria, and Mycoplasma. 

, 105–114. DOI: 10.1016/j.copbio.2021.06.027
4. Challener, C. Adventitious Agent Testing for Viral Vectors. 

 (9), 40-44.
5. Klug, B.; Robertson, J. S.; Condit, R. C.; et al. Adventitious Agents and Live Viral Vectored Vaccines: Considerations for Archiving Samples of Biological Materials for Retrospective Analysis. 

 (51), 6617–6625. DOI: 10.1016/j.vaccine.2016.02.015
6. Victoria, J.G.; Wang, C.; Jones, M. S.; et al. Viral Nucleic Acids in Live-Attenuated Vaccines: Detection of Minority Variants and an Adventitious Virus. 

 (12), 6033–6040. DOI: 10.1128/JVI.02690-09
7. Dubin, G.; Toussaint, J. F.; Cassart, J. P.; et al. Investigation of a Regulatory Agency Enquiry into Potential Porcine Circovirus Type 1 Contamination of the Human Rotavirus Vaccine, Rotarix: Approach and Outcome. 

 (11), 2398–2408. DOI: 10.4161/hv.25973
8. Ma, H.; Galvin, T. A.; Glasner, D. R.; Shaheduzzaman, S.; Khan, A. S. Identification of a Novel Rhabdovirus in Spodoptera frugiperda Cell Lines. 

 (12), 6576–6585. DOI: 10.1128/JVI.00780-14
9. Playter, G. Examining Next-Gen Technology for Adventitious Agent Testing. 

®
Volume 36, No. 8
September 2024
Pages: 29–30

When referring to this article, please cite it as Mirasol, F. Meeting Adventitious Agent Testing Needs for Complex Modalities. 

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.