| | Latest News | Catalent Commences Construction of New $20M Expansion to its Clinical Supply Facility in Schorndorf, Germany | The project will see the site’s footprint increase by 32,000 square feet (3,000 square meters) to add capacity for the storage and handling of clinical trial supply materials at controlled room temperatures between 15 and 25 degrees Celsius, and creates space in the original building to accommodate the installation of a new, fully automatic bottle filling line, and a dedicated area for Catalent’s FastChain® demand-led supply service. Work on the site is expected to be completed by June 2024. |
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| | Read More | Catalent Launches New Oral Developability Assessment and Manufacturing Solution to Advance Targeted Protein Degrader Programs |
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| Catalent announced the launch of the ProteoSuiteSM Oral, which allows the rational selection of orally developable targeted protein degrader candidates and their advancement into clinical trials. These emerging therapeutic modalities are typically highly potent, and present novel oral bioavailability challenges to formulators. |
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| | Read More | Harm Reduction Therapeutics and Catalent Sign Commercial Supply Agreement for Naloxone Nasal Spray to Reverse Opioid Overdoses |
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| Catalent has signed a commercial supply agreement to manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive™ (3.0 mg), for the emergency treatment of known or suspected opioid overdose. “This agreement marks a major milestone for Harm Reduction |
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| Therapeutics and is also a significant step forward in tackling a major public health issue in the United States,” said Carla Vozone, Vice President of Inhalation Strategy at Catalent. | | Read More | Catalent and Bhami Research Laboratory Enter into Licensing Agreement for Technology to Deliver High-Concentration Biologics Subcutaneously |
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| Bhami Research Laboratory (BRL) and Catalent announced a licensing agreement that will provide Catalent with access to BRL’s formulation technology to help enable the subcutaneous delivery of high-concentration biologic therapies. “This agreement allows Catalent Biologics to offer its customers a novel patented formulation that may be evaluated for enabling the delivery of high-concentration therapies by reducing viscosity,” said Julien Meissonnier, Catalent’s Chief Scientific Officer. “The potential for maintaining the stability of a drug with the convenience of a pre-filled syringe or auto-injector could have a significant impact on reducing the barriers to subcutaneous delivery of therapies and improving the patient experience.” |
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| | Read More | Catalent and Grünenthal Announce Successful Collaboration to Facilitate Expedited Clinical Development Timelines |
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| Catalent and Grünenthal Group have reached a milestone in a joint Chemistry, Manufacturing and Controls (CMC) development project for the reformulation of an investigational medicine to improve its bioavailability. Positive preclinical results from the molecule have allowed Grünenthal to progress its development program to first-in-human studies. In this phase, Catalent supported Grünenthal with the development of a bioavailability-enhanced formulation, which, moving forward, enables expedited clinical development timelines. |
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| | | Catalent Wins Six CDMO Leadership Awards |
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| Celebrating Catalent winning six CDMO Leadership Awards across the areas of Capabilities, Compatibility, Service, Quality, Expertise, and Reliability, Bernie Clark, VP of Global Marketing at Catalent, shares with Louis Garguilo, Chief Editor of Outsourced Pharma, how meaningful these honors are to Catalent. |
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| | | Life Sciences Knowledge Hub: Interview of the month featuring Catalent Chief Scientific Officer Julien Meissonnier |
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| In this interview with Life Sciences Knowledge Hub, Julien Meissonnier talks about Catalent’s mission to help people live better, healthier lives, and shares his thoughts on innovation, and how CDMOs are playing an ever more important role in making new modalities such as cell and gene therapies into new realities, and scaling development and manufacture to provide wider access to important new treatments. When asked whether it is more important for a CDMO to be able to offer science and technology platform technologies and such in the cell and gene space rather than the biologics or even the small molecule |
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| space, Julien replied, “In cell and gene therapies and emerging treatments, the level of manufacturing technological maturity is much lower than for small molecules and protein-based therapeutics, such as monoclonal antibodies, partly because these new therapies have, over recent years, been propelled to the clinics and to commercialization at a much faster pace than the now established modalities were. Catalent now has the tools to lead the CDMO industry in bringing the next generation of development, drug delivery, and manufacturing technology innovations to scale, so that more patients can benefit from these new therapies”. | | Read More | Balancing Change and Certainty in Manufacturing |
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| Bio/pharmaceutical manufacturers have been required to pivot in recent times because of a number of factors, including the shifting focus of drug development to next-generation modalities, pressurized supply chains, increasing adoption of digitalization, and intensified efforts to be more sustainable. Sridhar Krishnan, Vice President, |
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| “The Catalent Way” and Antonio Crincoli, Vice President of Engineering, Pharma and Consumer Health at Catalent, share insights on the key to balancing these significant shifts in the industry. “Improvements in manufacturing efficiency can be made through comprehensive quality management systems that focus on digitization, reduce human errors, and improve data integrity,” notes Krishnan. “These steps are backed up by having an operational excellence strategy, and a continuous improvement system, but whatever systems are in place, the most important step is a continuous investment in people, and the training of employees.” | | Learn More | Reducing Vulnerabilities in Upstream and Downstream Supply Chains |
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| In the latest issue of BioPharm International, Catalent expert Trish Demko outlines how leveraging specialized support, such as Catalent’s Case Management Services, can help makers of personalized medicines identify and minimize the myriad risks throughout the supply chain to patients. |
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| | | Catalent for Building Better Biotechs |
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| Case study: How Does a Proven CDMO Partner Help Early-Stage Biotechs? While developing a drug delivered by injection, an up-and-coming biotech company ran into an all-too-common challenge: Injection site reactions and sub-optimal pharmacokinetics. An attempt to reformulate mitigated the injection site reaction, but the pharmacokinetics were still not where they needed to be. As a CDMO with much experience of such issues, Catalent stepped in and suggested that rather than terminate the program or try to reformulate again, they could instead use the model-based dosing approach to explore new dosing protocols. By using a modified dosing regime, the biotech found that its product could achieve an overall superior profile to the existing standard of care drug, with better tolerability.
Ebook: “CDMO Playbook for Scaling the Emerging Biotech Companies” Biotech startups often emerge from scientific innovation, but navigating the often decade-plus journey from laboratory to pharmacy ultimately requires much more than that. While a drug or molecule may seem to hold promise, roughly 90% of all biotechs fail to place their product into the hands of doctors and patients. In this eBook, learn more about strategies that successful emerging biopharma and biotech companies have used along with their CDMO partners to move their discovery to market |
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| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs and Commercial Programs |
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| Biologics
Webinar | Exploring a One-Stop Integrated Solution for AAV Vector Clinical Production | May 3, 2023 Join this webinar to learn how the right process, clonal HEK293 cell line, and range of off-the-shelf plasmids, along with qualified analytical methods supports a robust supply chain for the development and manufacture of Adeno-Associated Virus (AAV) vectors, and the reduction of timelines to clinical evaluation. Register now
Join Catalent’s expert Dharmaraj Samuel, Ph.D., Director, Protein Science, Catalent Biologics, as he presents new data highlighting the improved efficacy and tolerability of SMARTag® antibody-drug conjugates (ADCs) as compared to marketed ADCs against the same targets, in his talk ‘Catalent’s SMARTag® ADC Technology: Precision Design Solutions to Build Best-In-Class Therapeutics’
Catalent expert George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, Catalent Biologics, will present Catalent UpTempo℠ AAV platform in his talk ‘One-stop Integrated Viral Vector Platform for Speed to Clinic’. Join this talk to learn how this scalable, CGMP-ready platform process can significantly reduce the time from gene to clinic. |
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| Pharmaceuticals and Consumer Health
RDD Europe 2023 | Nice, France | May 2-5, 2023 Hear Catalent’s David Wilcox, Director, Product Development, and Mark Ignaczak
Director, Innovation and Partnerships – Nasal Delivery, present ‘Synergies of Inhalation Product Development and Spray Characterization’ workshop during the Aqueous Agenda – Navigating Nasal Knowledge Space at RDD Europe 2023. Schedule a meeting Webinar | Strategic Considerations for Cell Therapy Manufacturing Scale-Up & Supply Chain Management | May 8, 2023
In this joint session presented by Maria Lopez, General Manager, Catalent Princeton, and Trish Demko, Director, Case Management Services, Catalent, as they address key challenges in the development, manufacturing, and supply chain logistics for autologous and allogeneic cell therapies. Register now
Clinical Trial Supply West Coast 2023 | Burlingame, California | May 9-10, 2023 Meet our Clinical Supply expert in booth 8 to learn how Catalent’s integrated services can help expedite your product through early development and clinical supply to market, as well as discuss our network’s solutions, including comparator sourcing, packaging & distribution. Register now
Vitafoods Europe 2023 | Geneva, Switzerland | May 9-11, 2023 Visit our booth and meet Catalent’s experts to learn how to accelerate growth in your supplement business with innovative, experiential dose forms. Let our experts help you get to market faster with our superior manufacturing capabilities for consumer health products. Schedule a meeting
Webinar | Achieving Desired Particle Size and Yield Through Efficient Micronization | May 9, 2023 Join this webinar as speakers discuss how with the right combination of technology and expertise, micronization can help to overcome many of the challenges faced by small molecule drugs and address the challenges and solutions to scale, yield and cost of goods for API particle engineering from formulation development through to commercial supply. Register now
2023 Global Drug Bioavailability Enhancement Summit | Princeton, New Jersey | May 16-17, 2023 How to leverage the advantages of Lipid-Based Formulation (LBF) in early development to expedite candidate selection of poorly soluble drugs? Join Derek Bush, Ph.D., Director, Rx Product Development at Catalent as he a shares insight on development considerations for Lipid-Based Formulation (LBF) from preclinical toxicology to clinical studies. Schedule a meeting
2023 Controlled & Modified Drug Release Summit | Princeton, New Jersey | May 16-17, 2023 Hear Catalent’s Karu Sukuru, R.Ph., Ph.D, Global Vice President, Rx Product Development, present on advances in softgel technology and gain insight into how softgel offers formulators versatility in designing patient-centric drug products. Schedule a meeting
ALS Drug Development Summit | Boston, Massachusetts | May 16-18, 2023 Meet the Catalent team in Boston to learn how Zydis ODT fast-dissolve formulation can offer patient-centric drug delivery for ALS as well as a wide range of other CNS indications. Schedule a meeting |
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Biologics Video: “ GPEx® Lightning: The Latest Cell Line Development Technology” Leveraging Catalent’s proven GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, GPEx Lightning combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.
Article: “Biopharma 4.0 – Spearheading Digital Transformation in the Biopharmaceutical Industry” For Contract Development and Manufacturing Organizations (CDMOs), transitioning to Biopharma 4.0 is crucial – the data and expertise amassed by these manufacturers represent an integral asset for their customers working to innovate in an increasingly competitive and fast-paced market. In this article, experts discuss insights on how to embrace changes for better outcomes for the biopharma manufacturing industry. |
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| Pharmaceuticals and Consumer Health Video: “CDMO Perspective on Partnering with Clients from Phase I through Commercialization” There are several key considerations when choosing a CDMO for the development and commercialization of your product, including the evolution of your product from early phase development to phase 3, ensuring a seamless transition throughout the development phases into commercialization, and the robustness of the manufacturing process. Sponsors also need to consider their external manufacturing partner’s capacity, capabilities, and technical expertise to troubleshoot and overcome challenges prior to launch. CDMOs such as Catalent should work with you to find the best delivery solution for your product and the targeted patient population to help ensure commercial and market success. Webinar: “Accelerate Your Program: Streamlined Phase Appropriate Technologies & Expertise” Each phase of drug development encounters specific hurdles that require specialized expertise and advanced technologies to overcome and to ensure readiness for the next phase. A holistic approach to a program with cohesive program management can offer a dedicated focus to the intricacies of each phase and beyond. In this webinar, CDMO experts at Catalent explain how the phase appropriate expertise and technologies of the OneXpress® Solution can help streamline development and manufacturing, speed up your program timelines and reduce risks to transform your science into a successful treatment. Article: “ CDMO Perspective on Clinical Supply Planning for Studies with Unconventional Timelines” There is a growing need to help sponsors of clinical study drugs save time, reduce costs, and quickly get their products to market without compromising safety. To do this, sponsors might have the option to conduct studies that do not conform to the standard Phase 1 through Phase 3 clinical timeline, depending on the drug being researched. What kinds of trials can be managed in this manner, and how can unconventional timelines help sponsors achieve these specific time and cost goals? |
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| | | | | In this 360° Virtual Tour of our site in Limoges, France, explore Catalent’s European center of excellence for early-phase clinical biologics formulation development and drug product fill/finish. |
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| Pharmaceuticals and Consumer Health
| Catalent’s clinical supply facility in San Diego provides comprehensive services to meet a variety of clinical trial supply needs for pharma and biotech companies, including but not limited to primary and secondary packaging as well as clinical storage and distribution (including cold chain support). Click here to explore. |
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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 hiring across sites in North America, Latin America, Europe and Asia Pacific.
Visit www.catalent.com/careers for more information. |
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