| | Catalent’s Incoming CEO Ready to
Stand on the Shoulders of Giants |
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| BioProcess Insider figuratively sat down with Catalent’s Chief Operating Officer Alessandro Maselli who is set to succeed John Chiminski as CEO effective July 1, 2022. In this exclusive interview, Maselli discusses Catalent’s past, present, and its future with him as CEO. |
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| | | Catalent Recognized as a US and UK Country Certified Top Employer 2022 |
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| The Top Employers Institute recognized Catalent as a Top Employer 2022 in both the United States and the United Kingdom. Being certified as a Top Employer showcases an organization’s dedication to a better world of work, which it exhibits through excellent HR policies and people practices. |
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| Top Employers Institute CEO, David Plink, commented, “Reflecting on the demanding year that has, like the year before it, impacted organizations across the world, Catalent has continued to show that it prioritizes maintaining excellent people practices in the workplace.” |
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| | | We are growing and hiring. #CatalentCares about you, join our talented community! #CatalentCareers |
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| | | Join Catalent experts at #DCATWeek
in New York This Month |
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| The Catalent team is excited to be back in New York City during #DCATWeek on March 21-24. Schedule your meeting today to meet with us and learn how we can help you on your next project. |
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| | | TFF Pharmaceuticals and Catalent Announce New Inhalation Dry Powder Development and Manufacturing Agreement |
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| Focused on the generation, testing and manufacture of inhalable dry powder formulations for a range of biotherapeutics, an agreement announced in March between TFF Pharmaceuticals, Inc. and Catalent set-out the terms for Catalent to provide its scale-up expertise and manufacturing capabilities to TFF Pharmaceuticals, as its preferred development and manufacturing |
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| partner, and for Catalent to be able to offer its customers access to the innovative Thin Film Freezing technology, which has the potential to increase the adoption of the pulmonary route for the systemic delivery of biotherapeutics. |
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| | | Catalent Expands Temperature-Controlled Clinical Supply Capabilities in Shanghai, China |
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| Catalent announced its plans to expand its Waigaoqiao Free Trade Zone (FTZ) facility to increase capacity for temperature-controlled storage and distribution of clinical supplies, as well as additional secondary packaging capabilities. At the time of the announcement, Roel de Nobel, Catalent’s Vice President and General Manager, APAC, Clinical Supply Services, |
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| said, “We have seen great demand for clinical supply services in China from international sponsors looking to conduct trials in the region and seeking Catalent’s experience in providing reliable, flexible, and integrated support.” |
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| | | | | Pharmaceutical Technology: Spray Drying Finds Growing Use for ASDs Amorphous solid dispersions (ASDs) are increasingly used to enhance the bioavailability of poorly soluble APIs. Contract development and manufacturing organizations (CDMOs) with knowledge and experience in this specialty area play a key role in the pharmaceutical industry by providing the capabilities to develop and manufacture ASDs. “The increased development of biologic-based drugs has fueled demand for spray drying as an alternative for the manufacturing and processing of biologics, instead of the more traditional liquid or lyophilized solid forms,” commented William Wei Lim Chin, Manager, Global Scientific Affairs, Catalent. | | Read More on pharmatech.com |
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| | | BioPharm International: Analysis of mRNA Therapeutics and Vaccines A key activity in the early development phase of mRNA therapeutics is the extensive characterization of the mRNA and nanoparticle’s quality attributes, as these are known to strongly influence biological efficacy. Given the pressure to shrink drug development timelines, access to faster and higher-throughput analytical methods has become vital. Indeed, it is essential that analytical approaches for use during mRNA product development and quality-control testing must keep pace to ensure the identity, safety, and efficacy of these new prophylactic and therapeutic modalities. | | Read More on biopharmainternational.com |
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| | | Nutritional Outlook: 2022 Contract Manufacturing Outlook:
What challenges do dietary supplement manufacturers face this year? This article highlights the key challenges and big wins to look out for this year within contract manufacturing. The wellness industry faces a double-edged sword: its products have never been more popular, yet production hurdles have never been higher. Catalent’s Dan Peizer, Vice President, Global Marketing & Strategy, Consumer Health says, "Catalent’s August 2021 acquisition of Bettera Wellness added gummy, soft chew, and lozenge capabilities to a portfolio that already included the company’s deep formulation and product-development expertise". He added, "This deep knowledge can help shorten the learning curve on new product development, and brings benefits in terms of reliability and, ultimately, market success." | | Read More on nutritionaloutlook.com |
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| | | Pharmaceutical Technology: Fostering Orphan Drugs Pharmaceutical Technology asked Catalent’s Judith Jones, FRSC, Director of Global Regulatory Affairs and Matthew Mollan, RPh., Ph.D., Regional Head of Operations, Early Phase Development North America, about the specific ways CDMOs can assist sponsors in developing, applying for, and manufacturing orphan drugs. |
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| | | Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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| | | Biologics
BEBPA 2022 US Bioassay Conference | Virtual | March 21-24, 2022
Meet Catalent Biologics experts and schedule a virtual meeting to learn more about biologics and large molecule analytical services.
Schedule a Meeting
BIO-Europe Spring 2022 | Virtual | March 28-31, 2022
Gain insights in the panel session on March 31 titled “Building and maintaining relationships with CMOs for effective advanced therapy manufacturing” featuring our expert panelist Barbara Sambuco, VP Operations, Drug Product. In addition, hear our expert speaker, Stephen Tindal, Director of Science and Technology, Europe in “Adaptive Phase 1 Clinical Trials with Catalent Xpress Pharmaceutics™ for Oral Small Molecules” on March 30.
Schedule a Meeting
12th Annual World ADC London | London, UK | March 29 - April 1, 2022 Hear our expert, Ayodele Ogunkoya, Ph.D., Sr. Research Scientist, Chemistry, Catalent Biologics, present “Advances in SMARTag® technology for the preparation of site-specifically modified antibody-drug conjugates with stable hydrophilic linkers and higher DARs.” Schedule a Meeting
World Vaccine Congress 2022 | Marriott Marquis – Washington, DC | April 18-21, 2022 Meet the Catalent experts at booth #205 to explore how Catalent’s capabilities and expertise is shaping the future of advanced therapeutics. Schedule a Meeting
Cell and Gene Therapy
18th Annual PEGS Boston Conference & Expo | Hynes Convention Center – Boston, Massachusetts | May 2-6, 2022 Schedule a Meeting
ISCT 2022 | Moscone Center West – San Francisco | May 4-7, 2022 Schedule a Meeting
Allogeneic Cell Therapies Summit 2022 | Boston, Massachusetts | May 9-12, 2022 Schedule a Meeting
ASGCT 25th Annual Meeting | Walter E. Washington Convention – Washington, DC (Hybrid Conference) | May 16-19, 2022 Schedule a Meeting
Clinical Supply Services
Clinical Trial Supply Europe 2022 | Madrid, Spain | March 22-23, 2022 Meet with Catalent’s Clinical Supply services experts at Booth 36 to discover how Catalent can help you excel in clinical supply strategy. Schedule a Meeting
DIA China 2022 | Suzhou, China | May 19-22, 2022 Meet Catalent’s experts at booth E11 to learn more about the trends of globalization and localization of drug development and innovation. Schedule a Meeting
Oral & Specialty Delivery
Exploring Pectin and the Advancement of Delayed-Release Technology | March 22, 2022 11 a.m. EST Recent innovations in oral drug delivery have introduced the use of versatile materials such as pectin, a naturally derived polysaccharide, to provide delayed release properties without the need for coating. In this webinar, experts discuss why the properties and structure of pectin are well suited to enable site-specific delivery. Featured Speakers, Sverre Arne Sande, Ph.D., University of Oslo, Norway, and Karunakar (Karu) Sukuru, Ph.D. VP, Rx Product Development, Softgel & Oral Technologies, Catalent, will also discuss the impact of modifying a pectin shell encapsulating a controlled release fill matrix on drug release profile and kinetics.
PBP World Meeting | Rotterdam, The Netherlands | March 28-31, 2022 Join Catalent experts for a poster presentation on ‘Formulation for Oral Delivery of Proteins, Peptides and Small Molecules with Poor Permeability 'and learn more about formulation approaches that could enhance oral bioavailability of macromolecules.
RDD2022: Respiratory Drug Delivery | Orlando, Florida | May 1-5, 2022 Meet with Catalent’s applied drug delivery experts in Florida and discover how Catalent can support your respiratory drug delivery needs. Schedule a meeting
2022 Controlled & Modified Drug Release Summit | Philadelphia - Hybrid | May 23-24, 2022 Join a presentation with Ron Vladyka, Director, Scientific Services, Catalent for a presentation titled ‘Twin Screw Granulation: A Novel Process for Modified Release Formulation’, where he will introduce a novel twin-screw granulation process for the development of controlled-release formulations. In addition, a review of top considerations in determining the appropriate technology for modified release dosage form manufacturing will be presented.
Consumer Health
In-Cosmetics Global 2022 | Paris, France | April 5 – 7, 2022 In-Cosmetics is all about the beauty of collaboration - connecting producers and suppliers of raw materials, fragrances, lab equipment, testing and regulatory solutions with researchers and buyers from personal care brands. We invite you to join in. Schedule a meeting
Vitafoods Europe 2022 | Palexpo – Geneva, Switzerland, & Online | May 2-13, 2022 (Online) & May 10-12, 2022 (In-Person) Meet Catalent experts at Booth G60 to find out how together, we could help bring your nutritional products to market. Schedule a meeting
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| A Catalyst in Drug Development |
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| Diogo Gomes Lopes, Ph.D.
Product Development Principal Scientist |
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| Diogo Gomes Lopes, Ph.D. is a Product Development Principal Scientist at Catalent’s Schorndorf, Germany, facility. He has a background in quality assurance, patient centric product design, continuous manufacturing and pharmaceutical engineering. Diogo and his team focus on development of solid oral dosage forms. His expertise involves taste masking techniques using lipid coatings. Discover what drives his passion for pharmaceutical development from pediatric to geriatric formulation. Access his works that include five peer reviewed articles and scientific posters to help you develop and design high quality patient centric drug products. |
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Biologics
Webinar: “ Catalent’s Chair and CEO Shares His Views About Drug Development and Manufacturing in a Pandemic” - In December 2021, John Chiminski was featured on the expert panel of STAT’s "A Look Ahead at Biotech in 2022" event, which focused on the ongoing battle against the SARS-CoV-2 virus and explored what might be in store for the biotech industry in the years to come. Webinar: “Formulation Strategies Moving from Intravenous to Subcutaneous and from Vial to PFS”- The biopharma industry continues to look for ways to improve patient compliance through the transition of intravenous (IV) to subcutaneous (SQ) administration, and/or vial to pre-filled syringe (PFS) presentation. In this webinar, Paresh Vadgama Principal Scientist, Biologics Formulation and Drug Product Development, Catalent and Randy Mrsny, Ph.D. Professor, Dept of Pharmacy and Pharmacology, University of Bath discuss the formulation development challenges, considerations, and potential solutions associated with these transitions that ensure the product’s safety and efficacy. Webinar: The Post-COVID Supply Chain – While drug supply chains generally held up during the pandemic, it was no easy feat. COVID-19 taught the industry just how vulnerable the far-flung supply chain could become, and it spawned new efforts to regionalize manufacturing and double down on automation. During this panel discussion, executives from Alnylam, Sandoz, Bayer, Amgen and Catalent share how their companies adapted to the challenges and what lessons they will take forward to ensure secure supply chains for the long haul.
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| Cell & Gene Therapy
Podcast: “ Podcast-Platform Processes for Streamlined Regulatory Filing and Time to Market for Gene Therapies” - One of the challenges facing gene therapy manufacturing is the lack of standardization in the process. Standardized methods, materials, analytics, and documentation can help reduce supply chain bottlenecks, increase efficiencies and lead to accelerated development timelines and smoother regulatory filings. In this podcast, Colleen Floreck, Vice President, Global Marketing and Strategy, Catalent Cell and Gene Therapy we will discuss how Catalent is working to simplify the supply chain, develop processes scalable for late-stage and commercial needs and accelerate timelines for production of clinical materials. Webinar: “ Accelerating Manufacturing for Next Generation hiPSC-Based Clinical Therapies” – Human induced pluripotent stem cell (hiPSC)-based therapy is currently at the forefront of a technology boom and is advancing at a rapid pace. In this webinar, our featured speakers will share their experiences with development and manufacturing of hiPSCs. The expert panel will highlight key considerations for driving clinical and commercial success with hiPSCs as starting materials, including aspects such as their derivation, expansion, and differentiation. The experts will also share strategies that can improve the speed, quality, cost of goods, differentiation, and scaling up of hiPSC-based therapies. Webinar: “ Accelerating Advances in Cell and Gene Therapy Production”- During this session, Catalent’s George Buchman, Ph.D. VP, Pre-Clinical Service and Process Development reviewed progress in several areas of advanced development and their impact on readiness for large scale manufacturing. He, in part, focused on adeno-associated virus (AAV) with discussions on improving transfection efficiency, batch-feeding/perfusion, new transfection reagents, advances in recovery, cell line engineering including stable/packaging lines and clonal selection, single use technologies, and other topics.
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Clinical Supply Services
Ebook: “ Transforming IMP into Clinical Supply: An Integrated Approach” - The end-to-end development process for creating new drug products can be very complex. From early formulation through clinical trials, sponsors are actively working to ensure their Investigational Medicinal Product (IMP) is appropriately developed for its indication and patients. With increased competition out in the market today, sponsors are also trying to speed up timelines to get their product to commercial launch faster, without sacrificing drug efficacy or safety. Working with a development and supply partner that offers integrated solutions can help sponsors meet these requirements.
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| Oral Drug Delivery
Case Study: “OneXpress ® Case Study – Enabling Successful SDD Scale Up” - A virtual biotechnology company, focused on the development and commercialization of a product to treat advanced solid tumors, partnered with Catalent for the development, clinical trial supply and scale-up of a spray-dried dispersion (SDD) program. Catalent’s early development center of excellence in San Diego developed a spray drying process for the client and supplied clinical trial material for their phase 1 and 2 studies. To supply upcoming phase 2/3 studies, Catalent efficiently transferred the program to its state of the art late phase and commercial spray drying site in Haverhill, U.K. Catalent deployed its integrated OneXpress Solution to expedite the transfer of this program to the late-stage manufacturing site while optimizing the utilization of a limited supply of API. Webinar: “Dosage Form Design and Patient Compliance-Exploring ODTs as a Patient-Centric Solution” – Patient non-compliance has a significant impact on the burden of healthcare costs. Its causes are due to a combination of influences, including specific disease type, age, and therapy regimen. In this webinar, experts provide an overview of the needs of different patient populations and examine the common factors that lead to non-compliance. Experts also discuss how an orally disintegrating tablet (ODT) may provide a solution to address such challenges and potentially enable more successful treatments. Webinar: “ Predictions for the 2022 Pharma Industry” - For the third consecutive year, Catalent’s CEO John Chiminski and Endpoints News’ John Carroll have a virtual fireside chat discussing their predictions for what 2022 has in store for the biopharma industry.
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| Consumer Health
Fact Sheet: " Gummy Delivery Technologies”- Gummy technology offers a chewable experience to deliver dietary supplement products with multiple options and customizations to bring your gummy product to life. Fact Sheet: " Lozenge Delivery Technologies”- Lozenge technology offers a unique and innovative delivery method to create an enjoyable supplement experience. Fact Sheet: “ Soft Chew Delivery Technologies” - Soft Chew technology offers a chewable experience to deliver dietary supplement products in an uncooked or cold-process that creates new opportunities in chewables.
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| | | 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. Explore the world-class late-stage and commercial manufacturing for vial fill/finish and secondary packaging of biologics and sterile products in this 360° virtual tour of Catalent’s facility in Anagni, Italy.
| Cell and Gene Therapies
Catalent has a network of cell therapy clinical and commercial manufacturing facilities in the U.S. and Europe. Discover its capabilities for the development and manufacturing of allogeneic and autologous immuno- and stem-cell therapies. Learn about the company’s expertise in both early and late-stage manufacturing as you get a glimpse inside our cell therapy facility in Gosselies, Belgium. In this 360° virtual tour, explore Catalent’s clinical and commercial manufacturing facility for gene therapies in Harmans, Maryland. At approximately 200,000 sq. ft., this state-of-the-art, FDA-licensed facility houses 10 CGMP manufacturing suites including fill/finish, and contains central services labs, testing labs, and acts as a central warehouse and supply chain hub for Catalent’s gene therapy solutions.
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| 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. The Boston, MA facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site has over 20 years of experience in inhalable dry powders and Catalent is the only CDMO globally to offer end-to-end spray drying, powder encapsulation and blister packaging capabilities from development through clinical and commercial manufacturing.
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| We are the Catalyst for your success. Join us! |
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| 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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Every molecule has a challenge. We have a solution.
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| | | or call +1 877 891 9609 to speak with one of our experts today! |
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