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Catalent in the Spotlight 

Alessandro Maselli Officially Takes up the
Mantle as Catalent President and CEO
 

Back in January, Catalent announced that Alessandro Maselli, then President and Chief Operating Officer, as the company’s next President and Chief Executive Officer. Maselli officially took on his new role as President and CEO, in addition to joining the company’s board of directors on July 1. Meanwhile, John Chiminski transitioned to the role of Executive Chair of the Board.  

“I’m energized by Catalent’s strong momentum, and I look forward to continuing the record of performance and growth that John established for Catalent, making it the development and manufacturing partner of choice across our customers’ diverse pipelines and product portfolios,” added Alessandro Maselli. 

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Catalent Announces New Operating Structure 

Following Alessandro Maselli’s takeover as Catalent’s President and CEO, the company announced changes to its operating structure and executive leadership team that went into effect July 1.

This new organizational structure includes a shift from four reporting segments to two, each representing roughly half of the total company revenue. According to Alessandro Maselli, Catalent’s President and Chief Executive Officer since July 1, the segment changes reflect evolving customer and industry trends and position the company to deliver its next level of growth and achievement.

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Drug Development & Delivery: SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing:
Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product 
 

Catalent: A Multi-Layered Approach to Minimizing Supply Risks 

This annual, exclusive Drug Development & Delivery report describes how drug sponsors and CDMOs are collaborating in the early phases of the drug development process. 

Catalent’s Elliott Berger, Chief Marketing Officer, shares his thoughts about the critical support outsourcing partners 

provide to meet  funding and regulatory milestones while accelerating customers’ programs towards manufacturing scale-up for launch. “New modalities make up an ex­panding part of the pipeline, and these have complex development, process, and manufacturing require­ments,” he says.

Read More on drug-dev.com

Latest News

The ‘Better Biotech’ webpage is now live!

Visit the new space dedicated to small and emerging pharma, with advice, strategies, and solutions designed for the specific needs of innovators. Leverage the experience gathered working with hundreds of small companies and learn how Catalent can help accelerate, simplify and de-risk the achievement of critical milestones.

Learn More

Catalent Expands Primary Packaging Capabilities at its
Clinical Supply Facility in Shiga, Japan

Catalent has expanded its primary packaging capabilities at its clinical supply facility in Shiga, Japan, through the installation of a high-speed blister packaging line to complement its existing automated bottling line.  The 6,000-square-meter Shiga site opened in October 2021 to support customers locally and globally, providing flexible clinical supply solutions, including Catalent’s FastChain® demand-led supply, white-glove handling and logistics.

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Catalent Supports US Launch of Phathom Pharmaceuticals’ New Products Following Regulatory Approval

Catalent welcomed the U.S. Food and Drug Administration’s (FDA’s) regulatory approval of Phathom Pharmaceuticals’s TRIPLE PAK™ (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA™ DUAL PAK™ (vonoprazan tablets, amoxicillin capsules), for the treatment of helicobacter pylori (H. pylori) infection in adults. 

These new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years.

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ISR Signs Development Agreements with Catalent to Scale-up its Spray-dried Nasal Vaccine Powder Formulation for Phase 3

ISR, an innovation-driven drug development company in the field of immunotherapy, has signed agreements with Catalent to facilitate the development of its spray-dried, SARS-CoV-2, dry powder, nasal vaccine, in readiness for its phase 3 clinical campaign. Catalent will scale up production of the spray-dried powder and provide analytical support from its Chelsea, Massachusetts, facility, which has extensive spray drying infrastructure and expertise necessary to meet clinical trial and commercial-scale volumes.

“ISR’s decades of experience in immunology, coupled with Catalent’s expertise in spray drying, and scaling up multiple programs will support ISR as they progress toward commercializing this nasally-inhaled vaccine,” said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “We are delighted to be partnering with ISR on this important product”

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Catalent in the News

Pharmaceutical Technology: Focusing on the Patient in Drug Development

For their Drug Solutions podcast, Pharmaceutical Technology interviewed a panel of experts for their views on drug dosage form trends that have had an impact on the bio/pharma industry in recent years. Cornell Stamoran, Ph.D., Vice President of Strategy and co-chair of the Catalent Applied Drug Delivery Institute, shares his thoughts about incorporating patient-focused thinking into drug product design and its benefits to patients.

Listen to the Podcast on Pharmtech.com

Tablets & Capsules: Boosting Bioavailability:
Micronization can Increase Oral Uptake and Improve Solubility

Drug Delivery often offers poor oral bioavailability, and developing more bioavailable formulations remains a challenge to scientists creating new oral dosage forms. As poorly soluble drug molecules are increasingly prevalent in the development pipeline, innovators are turning to technologies such as micronization to improve the bioavailability and solubility of these challenging compounds. 

Beyond that, micronization can help develop suspensions as well as other formulations such as dry powders for inhalation, and improve the content uniformity of highly potent active pharmaceutical ingredients.

Read More on Tabletscapsules.com

Pharmaceutical Technology: Development of Coprocessed Excipients


Coprocessed excipients are blends of different excipients subjected to physical processing that leads to modifications of their physical structures without causing any chemical changes. Adoption of coprocessed excipients has been slow, however, because even when prepared using compendial excipients, they are considered “novel” by regulators. Regulatory hurdles and higher costs present the biggest challenges suggests Dejan Lamešić, Ph.D., Head of formulation and process development, Softgel and Oral Technologies at Catalent.

Read More on Pharmtech.com

BioProcessonline: Radiance® Label-Free Monitoring of AAV Transfection in HEK293 Cells Using Laser Force Cytology™


As a leader in the gene therapy field, Catalent Cell and Gene Therapy strives to incorporate the most advanced analytics in its processes in order to provide high quality, innovative solutions for its customers. In this technical note, collaborative efforts are described between Catalent and LumaCyte to compare AAV production with three different transfection reagents using both LFC and a digital droplet PCR (ddPCR) based viral genome titer assay.

Read More on Bioprocessonline.com

Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs

Clinical Supply Services 

Bioplus-Interphex Korea 2022 | Seoul, South Korea | August 3-5, 2022


Meet Catalent’s clinical supply experts to learn more about our expertise, capabilities, and network in APAC and across the globe, that can help optimize plans to supply your trials.

Schedule a Meeting

Oral Drug Delivery


New updates in Drug Formulation & Bioavailability | Copenhagen, Denmark | September 6, 2022 2


Meet with Catalent expert Jan Neelissen, Ph.D. in Copenhagen at the Catalent booth to learn more about how PBPK modeling could help predict drug absorption in early drug development.

Connect In Pharma 2022 | Geneva, Switzerland | September 14-15, 2022


Meet the Catalent team at booth #E10 to learn more about Catalent’s solutions that are shaping the future of drug delivery and contract manufacturing.

Schedule a Meeting

12th American Drug Delivery & Formulation Summit | San Diego | September 26-27, 2022


Meet the Catalent team at the 2022 Summit to learn more about Catalent’s innovative solutions that can help mitigate risk and get your molecule to the market faster.

Schedule a Meeting

Nordic Life Science Days 2022 | Malmö, Sweden | September 28-29, 2022


Meet the Catalent team at booth #20 in the main exhibition hall to learn how Catalent can help accelerate, simplify and de-risk the achievement of critical milestones in the drug development journey.

Schedule a Meeting

Biologics


World ADC San Diego 2022 | San Diego | September 6-9, 2022


Meet Catalent’s biologics experts Penelope Drake, Ph.D and Greg Bleck, Ph.D and learn more about SMARTag ® technology and how it can accelerate the path to ADC pre-clinical screening and clinical development.

Schedule a Meeting

BPI East 2022 | Boston, MA | September 27-30, 2022


Meet Catalent’s experts in Boston to learn more about the latest updates on improving efficiencies across all phases of biopharmaceutical development and production.

Schedule a Meeting

Cell and Gene Therapies


Advanced Therapies Europe 2022 | London, UK | August 31 – September 1, 2022


Meet our Catalent Cell & Gene Therapy experts to learn more about our integrated development and manufacturing capabilities including plasmid DNA, viral vectors, and autologous and allogeneic cell therapies.

Schedule a Meeting

CAR TCR Summit US 2022| Boston, MA | September 19-22, 2022


Meet Catalent’s experts in cell and gene therapies at Catalent booth #4 to learn more about current perspectives, strategies, and technologies in CAR-T therapies.

Schedule a Meeting

A Catalyst in Drug Development

Nicolas Thurin, Ph.D.
DIRECTOR, SCIENTIFIC COMMUNITY AND OFFICE

Nicolas Thurin, Ph.D., is based at Catalent’s Brussels, Belgium, facility. With more than 15 years of experience as a scientist specialized in the manufacturing of sterile injectables, he has developed and managed Catalent’s analytical product development and quality control laboratories, helping to bring many customer projects to fruition. Since 2020, as a director of the company‘s scientific community, he has taken responsibility for the management of Catalent’s scientific community and office. 

Learn how leveraging the experience and expertise of its scientific community allows Catalent to deliver products faster, helping people live better and healthier lives. Access his published works that include presentations and posters below.

Access His Works

Top Content

Biologics

  • Podcast: " Obstacles & Opportunities in Orphan Biologics- From Development to Production and Supply" - Developing therapies for rare diseases has always come with a unique set of challenges such as difficulty in assessing clinical relevance and logistical and manufacturing obstacles related to the production of treatments. For biologics, R&D and production costs also tend to be higher. This panel of experts will discuss how to overcome obstacles that span from discovery to launch of orphan drugs as well as discuss the needs of patients and drug developers in orphan biologics development.

Cell & Gene Therapy

  • Fact Sheet: "UpTempo Virtuoso™ AAV Platform Process" - Catalent recently introduced its new, UpTempo Virtuoso platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform process is scalable and CGMP-ready for viral vector manufacturing and can reduce the current 18-20-month development timeline for drug products by half, enabling rapid first-in-human clinical evaluation.

  • Fact Sheet: "Industrializing iPSC-Based Cell Therapies" - Catalent’s iPSC banks utilize specialized reprogramming technology to transform commercial-use donor consented, clinically approved, cord blood collections into HLA-homozygous lines that are immune compatible with a wide population. The cell banks meet the requirements of major regulatory agencies, and the iPSC lines and corresponding donor tissue undergo extensive characterization.

Oral Drug Delivery

  • Q&A Article: " Intranasal Drug Product Development -From Formulation to Scaleup Manufacturing" - The intranasal delivery route is frequently used to treat both acute and chronic indications. In this Q&A article, Catalent experts Jan Neelissen, Ph.D., Kiran Amancha Ph.D., and David Wilcox discuss intranasal drug product development, in particular best practices and key considerations, from formulation design to manufacture and scale-up. 

  • Article: "PBPK Modelling for Optimizing Controlled Release Dosage Form Development" -  In this executive summary, experts describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of physiologically based pharmacokinetics (PBPK) modelling, and discuss how modified release products can be developed to deliver optimal patient outcomes. 

  • Webinar: "Advanced Troubleshooting for Spray Drying of Pharmaceuticals" - Spray drying offers multiple opportunities for improving the formulation of both poorly soluble compounds and inhaled drug products. Although spray drying is a well-established manufacturing process, challenges persist throughout the development process and novel applications are continuously evaluated. Join this webinar to hear from a panel of experts on the critical challenges of spray dried powder formulation development, risk mitigation strategies and the effect of material and process parameters on the physical and chemical properties of the spray dried powder of pharmaceutical products. 

Clincal Supply Services

  • Article: " The Value of Specialized Expertise for Efficient Management of Clinical Supply Budgets" - For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep a project within budget. This specialist can, and should, be involved in both the development of the supply strategy and the maintenance of supply costs for the duration of the study. In this interview with Pharmaceutical Technology, Catalent expert Christin Lau details the ways that an FPA can provide value to sponsors.

Consumer Health

  • Webinar: " Innovation to Grow Your Supplement Business Now- Dietary supplement brands are looking for innovation that can help them grow. To support the market demand and increased adoption of supplements, Catalent have gathered a collection of recent consumer, market, and product trends to suggest a number of near-term growth opportunities that market participants should consider in order to grow their business at a time when consumers are open to expanding their supplement options. Join us for a short webinar that matches trends to near term innovations that can be launched in a matter of months.

Virtual Site Tours

Biologics Development and Manufacturing

  • In this 360° Virtual Tour at Catalent’s facility in Bloomington, Indiana, explore our North American Center of Excellence for early-phase clinical biologics formulation development and drug product fill/finish.

Cell and Gene Therapies

  • In this 360° Virtual Tour, explore Catalent’s Houston clinical development and manufacturing facility for cell therapies. The state-of-the-art facility, at approximately 32,000 sq. ft., houses eight CGMP clean rooms, two tech transfer labs, and fill/finish services. The site has broad cell type expertise across immunotherapies and stem cells for both autologous and allogeneic cell therapy programs.

Oral Development and Manufacturing

  • In this 360° Virtual Tour, explore Catalent’s center of excellence for late phase and commercial-scale spray dry manufacturing in Haverhill, U.K. The site offers industry leading expertise in the scale-up and commercialization of spray dried dispersions as well as a broad range of integrated analytical support services.

Consumer Health

  • In this site tour, explore Catalent’s Softgel manufacturing site located in Buenos Aires, Argentina. This facility supplies hundreds of Consumer Health & Pharma products to clients in Latin America, North America and Europe and provides to our partners’ the benefit of best-in-class standards.

We are the Catalyst for your success. Join us!

Catalent ignites the development of their future leaders by continuously investing in their employees and creating an innovative environment to advance their potential. We are growing rapidly across sites in Bloomington, Indiana; Madison, Wisconsin; Harmans, Maryland; Kansas City, Missouri; and elsewhere.

Visit www.catalent.com/careers for more information.

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