| | Catalent Acquires Facility in Oxfordshire to Expand Biologics Capabilities in the UK and Across Europe |
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| Catalent announced the acquisition from Vaccine Manufacturing and Innovation Centre UK Limited (VMIC Ltd.) of a biologics development and manufacturing facility currently under construction near Oxford, U.K. |
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| It plans to invest up to $160 million (£120 million) to complete the building of the facility and equip it with state-of-the-art capabilities for the development and manufacture of biologic therapies and vaccines, including mRNA, proteins, and other advanced modalities. It is expected that the new facility will employ more than 400 people and support public and private organizations seeking to develop and manufacture biotherapeutics. |
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| | | Catalent Biologics Completes $30 Million Project for Biopharmaceutical Development and Drug Product Manufacturing in Limoges, France |
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| On a mission to transform the site into a European center of excellence for biopharmaceutical development, drug product fill/finish services, and packaging, Catalent announced the completion of a $30 million (€27 million) project at its facility in Limoges, France. |
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| “This investment has transformed the Limoges site into a world-class facility to support the development of early phase and small-scale commercial biologic drugs, and offers customers integrated services to accelerate programs towards and through the clinic, and ultimately to market. Even prior to completion, multiple clinical and commercial customers have already signed contracts for programs to be undertaken at the site,” commented Mike Riley, Catalent’s President, Biotherapeutics. |
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| | | Catalent Appoints Frederic Cedrone as Vice President, Corporate Innovation |
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| Frederic Cedrone, Ph.D., was appointed as Vice President, Corporate Innovation at Catalent. Dr. Cedrone will collaborate closely with Catalent’s scientific teams and external partners to leverage innovative technologies in the development of emerging therapeutic modalities. |
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| | | Catalent Publishes Third Annual Corporate Responsibility Report |
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| In March, Catalent published its Corporate Responsibility (CR) Report for its most recent fiscal year, which ended June 30, 2021. The report is the third since Catalent launched its CR strategy to address a wide range of environmental, social, and governance (ESG) topics related to its business. | | Read More |
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| | | Drug Development & Delivery: SPECIAL FEATURE – Solubility & Bioavailability: Utilizing Enabling Technologies Solubility-limited absorption remains a key challenge in terms of bioavailability for a large number of compounds looking to progress from the discovery phase towards the clinic. Increasingly, these molecules also exhibit high melting points and poor organic solubility, making these so-called “brick dust” compounds extremely difficult to process using conventional solubility-enhancing methods such as hot melt extrusion or spray drying. | | Read More on Drug-dev.com |
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| | | Pharmaceutical Technology: The Shape of Dosage Forms It is well-known that oral solid dosage (OSD) forms remain the market leader, with recent research estimating the market size to be worth nearly $8.5 billion by 2027 (1). For Cornell Stamoran, Ph.D., Vice-President of Strategy and Co-chair of the Catalent Applied Drug Delivery Institute, a key trend impacting drug dosage forms has been the increasing complexity of drug formulations. “[This increasing complexity has been] driven by strong pipeline growth of newer modalities and mechanisms, the need for targeted delivery, and bioavailability-challenged compounds, along with more frequent use of formulations and dose forms to enable patient self-administration, or reduce the complexity of treatment regimens,” he says. “We have also seen important progress in gene therapies using adeno-associated viral vectors and lipid nanoparticles to deliver messenger RNA.” | | Read More on pharmatech.com |
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| | | Manufacturing Chemist: Why outsourcing makes sense for orphan and rare diseases When it comes to complex, niche orphan drugs, a large, integrated CDMO can offer advantages to a sponsor as it is likely to have access to an international network of state-of-the-art facilities, alongside a team of highly skilled, experienced technical experts. Using a single partner with integrated capabilities can reduce the need for a sponsor to manage multiple suppliers and co-ordinate activities between them, as well as assist greatly in accelerating timelines and reducing programme risks to ensure successful orphan drug product development for patients in need. | | Read More on Manufacturingchemist.com |
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| | | Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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| | | Biologics
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
Cell & Gene Meeting on the Med | Hotel Arts Barcelona – Barcelona, Spain (Hybrid Conference) | April 20-22, 2022 Connect with Catalent Cell & Gene experts onsite to learn about our expanding advanced therapeutics capabilities from early development to commercial-scale manufacturing for plasmid DNA, viral vectors, vaccines, and autologous and allogeneic cell therapies. Schedule a Meeting
18th Annual PEGS Boston Conference & Expo| Hynes Convention Center – Boston, Massachusetts| May 2-6, 2022 Stop by to talk with our experts in booth 221, and hear Catalent Biologics’ VP of R&D, Greg Bleck, PhD, present “Shortening Clinical Developments Timeline Using Novel Gpex® Lightning Technology For Generating Stable, High Producing Cell Pools And Cell Lines” on Tuesday, May 3rd. Schedule a Meeting
ISCT 2022 | Moscone Center West – San Francisco | May 4-7, 2022
Visit Catalent Cell & Gene Therapy in booth 316 to learn more about our early development to commercial-scale manufacturing capabilities , including off-the-shelf and custom iPSC banks, MSCs, exosomes, and HSCs. Schedule a Meeting
Allogeneic Cell Therapies Summit 2022| Boston, Massachusetts| May 9-12, 2022
Schedule your meeting to Catalent Cell & Gene Therapy team in Boston and learn more about how our development, scale-up, and manufacturing expertise can help bring your life-changing treatments to patients.
Schedule a Meeting
ASGCT 25th Annual Meeting| Walter E. Washington Convention – Washington, DC (Hybrid Conference) | May 16-19, 2022 Visit the Catalent Cell & Gene Therapy team in booth 234 and hear our expert , George Buchman, Ph.D., VP, Pre-clinical and Process Development, will present "AAV Platform Process Accelerating Production from Gene to Clinic" on May 17.
Schedule a Meeting
Clinical Supply Services
GCSG 2022 US Annual Conference | San Antonio, Texas | May 1-4 2022 Explore Catalent's solutions to your clinical supply challenges. Join us live in San Antonio, participate in our expert speaking engagements and schedule to meet with our clinical supply experts in booth 24.
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
Advanced Troubleshooting for Spray Drying of Pharmaceuticals | Virtual webinar | April 21, 2022 11am ET | 4pm GMT | 5pm CET 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.
Early Drug Development: From Molecule to Patient | Virtual webinar | April 26, 2022 | 4pm CET What determines the success or failure of partnerships in new product development? How could small biotech startups create a faster and cost-effective way to bring new treatments to patients? In this webinar, experts will explore the journey from molecule candidate selection to first in human clinical studies, discussing the process from initial formulation conception to forming accelerated pathways to clinical trials. Attendees will have opportunities to discuss molecule developability, formulation development and the clinical trial supply manufacturing process, as well as ask specific questions relating to their own research and development.
Advance Your Program Through Target Product Profile Definition and Dose Design Virtual webinar | April 28, 2022 | 11 am ET
A key contributor to a drug product’s long-term success is the Target Product Profile. In this webinar designed for drug developers and pharmaceutical and biotechnology consultants, experts review the importance of the Target Product Profile. Jim Spavins, Principal of Spavins Consulting, LLC and a former SVP of Pfizer’s industry-leading Pharmaceutical Sciences organization, gives his expert advice on developing a successful TPP. In addition, Catalent’s Nathan Bennette will introduce the new technology OptiDose® Design Solution that is available for the assessment process. Register now to learn how TTP could help you bring a successful therapeutic to market.
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. Hear Alan Watts, Director Innovation and Partnerships – Orally Inhaled Delivery at Catalent present “Development of High Dose Powders for Inhalation” on May 3. Schedule a meeting
Formulation & Delivery UK | London, United Kingdom | May 5-6, 2022
Join a presentation with Andy Maitland, Operations & Supply Chain Director, Catalent to understand the key benefits of using micronization for the development and manufacture of highly potent compounds.
2022 Controlled & Modified Drug Release Summit | Philadelphia - Hybrid | May 23-24, 2022
Join a presentation with our Catalent expert 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.
Formulating the Future: Accelerating Oral Drug Development and Manufacturing | London, United Kingdom | May 31, 2022 | 9am-5pm BST Oral solid dosage forms remain a preferred option for many pharmaceutical drug developers. However, their successful development and manufacture still presents several unique challenges and opportunities. Join this upcoming workshop to discover how you could accelerate progression to the clinic and on to market success.
Consumer Health
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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| Amruta Mhashilkar MD Ph.D., MBA Lead Scientist |
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| Dr. Mhashilkar is a Lead Scientist at Catalent’s St. Petersburg, Florida facility. She earned her MD at Grant Medical College, a Master of Public Health and doctorate at the University of South Florida and completed her MBA at Florida Southern College. Dr. Mhashilkar specializes in lipid-based softgel formulation for immediate and extended release. She also works on process development and regulatory CMC support. Find out what drives Dr. Mhashilkar’s passion for softgel formulation - read her published works, which include five peer-reviewed articles. |
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Biologics
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
Webinar: “Harnessing Parallel Workstreams to Speed Your Biologic into Phase 1-3 Clinical Trials” - The path from drug substance development, through drug product manufacturing and into the clinic is a lengthy and largely linear process. Seeking out opportunities to run workstream activities in parallel through an integrated services approach can significantly shorten the time it takes to get from development into the clinic. This webinar will explore the feasibility of integration and how taking parallel approach enables each activity to be fully executed within a typical vs compressed timeframe, yet enables the overall project timeline to be shortened, often significantly. Webinar: “Roles and Responsibilities of Specialized Clinical Supply Experts” - When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains. Having a team of individuals with specialized expertise in different areas of clinical supply—including protocol review and early operational planning, to managing the development and execution of a sound clinical supply strategy—can prove invaluable to the overall suitability and performance of the supply chain, and in turn, the successful execution of the study itself.
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| Oral Drug Delivery
Article: “HPAPI Development and Manufacturing Using Micronization Technology” - The industry continues to shift towards the use of high potent active pharmaceutical ingredients (HPAPIs), which have the potential to offer more effective treatments at smaller doses. For HPAPIs, micronization is a well-established, cost-effective and scalable process to address bioavailability and drug delivery challenges facing certain highly potent oral drugs. While HPAPIs offer significant therapeutic benefits, their potent characteristics present risk so it is critical to take steps to secure the safe handling capabilities necessary to contain, develop and manufacture these compounds. Article: “ Concept to Dosing: Challenges in New Orphan Drugs ” – With significant market opportunity available and dedicated regulatory pathways defined, the number of orphan drug programs are growing globally. As drug developers look to address unmet medical needs for orphan diseases, working with experienced partners can help in navigating key challenges such as a limited active pharmaceutical ingredient supply, efficient small-scale manufacturing for small patient populations and distribution logistics. Read this article that shares insights from industry experts on key strategies for managing an orphan drug program. Webinar: “Navigating your biopharma drug candidate through early and mid-stage clinical trials” – Decisions made throughout early and mid-stage clinical trials impact late-stage results and sometimes, entire programs and companies. Since some obstacles can prove overwhelming for startups, there is a lot to learn from those who successfully walked the path.
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| Consumer Health
Webinar: “ New Experiences in Supplements” - In the dietary supplements market, several factors affect consumer experience, with one of the most influential and important being the delivery format. There has been a notable shift in how consumers want to take their daily supplements, with enjoyment and ‘the experience’ of taking certain products now taking center stage. In this webinar, learn how this trend will affect the growth of the supplement market both today and beyond. Webinar: “ New Experiences in Beauty”- In the beauty market, many factors influence consumers’ decisions on the products they will buy. Whether conserving the product’s potency so that it is delivered at full strength, or that the product is manufactured and delivered in a sustainable way, the market is rapidly evolving towards products that provide meaningful, and even delightful experiential benefits alongside function. In this webinar, we will look deeper at the trends and innovations in consumer experiences of the topical beauty market, and the lasting impact of this trend on the market moving forward.
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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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