Catalent Clinical Supply - OneBio Suite: Integrated Biologics Development, Manufacturing and Supply

On February 5, 2024, Novo Holdings announced their intention to acquire pharma and biotech CDMO Catalent at US$16.5 billion. Read more about what this means for the pharmaceutical industry as a whole, from drugmakers to their partners in manufacturing. 

Novo Nordisk’s holding and investment parent company will acquire the publicly owned CDMO at the end of 2024, taking it private and selling three of its drug manufacturing facilities to Novo Nordisk. 

Catalent has the right scale and experience across a wide range of dose forms and geographies to meet your manufacturing needs and supply better treatments to your patients and consumers. Our broadest capabilities (oral, biologic, inhaled, sterile), unmatched tech transfer and product launch experience and scale in Branded, Generics, Over-the-Counter Medicines and Nutritional Supplements will meet your needs and drive growth throughout the product lifecycle.

After another year of impressive nominations for the CPHI Pharma Awards our winners were announced at CPHI Barcelona in October. In this series of interviews, we speak to the people and teams behind the award-winning projects, concepts, and technologies. 

Your therapy has so much potential—we have the passion to optimize it. Achieving preclinical formulation targets is only half the battle in successful drug development. Without solutions for compliance barriers and patient acceptance, outcomes for your drug may suffer. By applying advanced dose design principles early, we can help you achieve optimal absorption profiles as well as improve patient adherence and compliance, leading to greater payer acceptance, more scripts, and potentially better patient outcomes.

The increasing outsourcing trend among pharmaceutical companies represents a promising opportunity for CDMOs. This panel discussion at CPHI Worldwide touched upon some of the opportunities, hurdles, and trends ahead for the CDMO market

A toolkit of superior technologies to overcome all your molecule’s challenges and processing difficulties to get the optimal dosage form.

By completion at the end of 2022, the campus will accommodate 18 cGMP viral vector manufacturing suites

The transaction is expected to accelerate Catalent's growth in global softgel and oral dose formulation and manufacturing services

Catalent brings over 85 years of experience and expertise in softgel, fast-dissolve, and oral solid dose formulation development and supply of over-the-counter, nutritional supplement and beauty products to market. With consumer-preferred dose forms and advanced development and commercial manufacturing expertise, Catalent helps differentiate and grow brands, to get better products to market faster. 

The collaboration will see Catalent install a commercial-scale KinetiSol technology manufacturing line at its Somerset, New Jersey, facility

OTC Trends, Monograph Reform, and Innovation

Two 2,000-liter single-use bioreactors to be installed as part of first phase expected to be operational in April 2023

Beauty Brochure

The company will use its orally disintegrating tablet technology Zydis for JOS Pharmaceuticals' licensed CBD product

OTC Product Library

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Promethera Biosciences, the leader in advanced therapy development for severe liver diseases, today announced that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 square-foot (3,010 square-meter) facility in Gosselies, Belgium. The facility will accommodate Catalent’s new commercial-scale plasmid DNA (pDNA) manufacturing and will provide the opportunity for the immediate growth of Catalent’s pDNA service offering, which was recently acquired from Delphi Genetics to support the growing cell and gene therapy pipeline.

Learn what OTC Market Leaders view are the biggest opportunities and barriers to innovation and growth.

•Over 200 industry leaders surveyed in 2019

•Key opportunities and barriers to growth identified

•Role of external partners and key characteristics ...

New facility at Gosselies site will host commercial scale pDNA manufacturing as Catalent extends its cell and gene therapy footprint

device assembly & packaging

CPHI asks industry experts at Beximco Pharmaceuticals, Catalent, DIA and Thermo Fisher Scientific to weigh in on the remarkable innovations we have witnessed and what lasting impacts they may have on our industry in a post-pandemic world

OneBioSM Suite a single solution integrating development through complete clinical and commercial supply to simplify, accelerate and de-risk your biologic development

With CPHI North America fast approaching, we ask Karen Flynn (President, Biologics & Chief Commercial Officer, at Catalent), Hamilton Lenox (Senior Vice President of Business Development, Sales & Marketing, at LGM Pharma), and Mike Kleppinger, Chief Commercial Officer, at AMRI) to weigh in on strategies the industry can use to build supply chain resiliency which ensure uninterrupted access to medicines

drug product manufacturing product card

The company's custom single run single-use fermenters supplied on fast-track schedule to support flexible manufacturing of plasmid DNA

Development Card

The extended collaboration comes after reaching the initial milestone of producing 100 million doses

Biomanufacturing Data Card

The CDMO's Zydis technology will help the Canadian biotech to develop fast-acting, shorter-duration formulations of its potential therapy for treatment-resistant psychiatric disorders

By Philip W. Wills, Chief Commercial Officer at Catalent Gene TherapyGene therapy is a rapidly growing area in health care but, now the promise has been shown, we must focus on improving the manufacturing process and reducing costs

The company acquires a pDNA CDMO and launches pDNA development and manufacturing services at its Rockville, Maryland facility

technical note

The CDMO will manufacture recently FDA-approved Lupkynis as a softgel dosage form at its St Petersburg, Florida, facility

In a little over a year, Catalent has expanded into the Cell and Gene therapy space through acquisitions. In this podcast you will hear from Colleen Floreck, Sr. Director, Strategy & Marketing, Cell & Gene Therapy, about Catalent’s journey into this exciting and growing space, overcoming challenges, and the company’s commitment to its partners.  

The agreement allows the CDMO to "stay on the forefront of emerging indications and cell types"

Direct-to-patient clinical supply is a critical component for decentralized clinical trials. Direct-to-patient clinical supply can be aligned with the needs of the study and its patients in mind. This video explores several approaches to direct-to-patient clinical supply that are in use today and how they can be used to flexibly support today’s decentralized clinical trials.  

The CDMO will provide packaging, labeling and distribution services through its FastChain demand-led supply offering

Timeline acceleration is critical in today’s highly competitive drug development environment. Clinical sponsors must take action to streamline the process.

The agreement comes hot on the heels of FDA approval of Gavreto — Blueprint Medicines' new treatment for lung cancer

MGB Biopharma (MGB), a biotech company based in Scotland, U.K., is developing a new class of anti-infective medicine based on Minor Groove Binder compounds. MGB-BP-3, a novel small molecule is currently in Phase 2a in the U.S. and Canada. The drug is being developed for the treatment of Clostridium difficile-associated diarrhea. The Catalent sites located in San Diego, CA and Kansas City, MO offered a tablet formulation as a solution to MGB’s needs ,in the form of OptiForm® Total Supply, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients. Within five months, the first clinical trial kits were successfully delivered to MGB’s patients.

Catalent today announced that it is investing $130 million to add five additional Phase 3 through commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland.

Formulating drugs for optimal stability and bioavailability is fundamental to the development of new pharmaceutical products. Once developed, these products must then be delivered to patients in the clinic. Since pharmaceutical scientists often work in isolation from the supply chain and clinical operations personnel responsible for clinical packaging and delivery of patient kits, there is an ever-present risk of potentially foreseeable and avoidable problems occurring further down the line. This article explores the benefits of a more integrated approach in which the chemical, manufacturing, and controls (CMC) teams and clinical teams work together at an early stage to achieve greater success for both the development program and patients.

Catalent today welcomed the news from Nocion Therapeutics, Inc., a biopharmaceutical company developing novel small molecule charged sodium channel blockers, that its first patient has been dosed with NOC-100, an inhaled formula of its NTX-1175 small molecule candidate.

As a worldwide clinical supply services leader, Catalent has the expertise, and innovative solutions to improve efficiency and reduce your trial timelines. With our capacity across every phase of development, we offer you the peace of mind that comes from having one company manage your supply chain throughout your product’s entire lifecycle.

 

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced it is to invest $9 million in a new clinical supply facility in San Diego, due to open in the summer of 2020.

OneXpress is a single integrated solution that provides the fastest pathway from clinical to commercial manufacturing. By taking a proactive approach and assessing production considerations early in development, our teams help you reduce risk by working in parallel to address potential roadblocks and ensure robust processes from clinic to launch.

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced the launch of its new OneXpress™ service for the integrated development, scale up and manufactur...

Zydis® orally disintegrating tablet is a unique, freeze-dried oral solid dosage form that disperses almost instantly in the mouth – no water required. It is an ideal technology for pediatrics, geriatrics and those with difficulty swallowing. It also helps improve compliance and offers market differentiation.

Catalent to manufacture clinical batches of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, for European trials in 2021.

OneXpress is a single integrated solution that provides the fastest pathway from clinical development to commercial manufacturing. By taking a proactive approach and assessing production considerations early in development, our teams help you reduce risk by working in parallel to address potential roadblocks and ensure robust processes from clinic to launch.

The partnership will focus on developing multiple ADCs using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

Catalent offers end-to-end spray drying solutions from early-phase development through to clinical supply, and scale-up to commercial finished dose forms. In 2019, Catalent expanded the capacity of its global spray drying operations through an agreement with Sanofi Active Ingredients Solutions (SAIS), an industrial platform of Sanofi, under which Sanofi provides Catalent with access to its spray-drying manufacturing capabilities at its Haverhill, U.K. facility. With subsequent additional investment into the site to expand its SDD capabilities, and alongside Catalent’s  global network of downstream dosage form manufacturing facilities, Catalent is well positioned to serve our global customers with end-to- end SDD solutions.

The company will prepare the Harmans facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing later this year.

This Roundtable will feature a high-level panel discussion from industry experts, with numerous opportunities for audience interaction – polls, Q&A and break-out networking sessions. A great opportunity to deep-dive into specific topics, discuss opinions and gather insights from the wider pharma community. After decades of slow and steady progress and thanks to clinical, manufacturing, and technological advancements, the huge potential of cell and gene therapies is being recognised. This market growth requires significant investments in disruptive technologies to enhance safety and activity as well as reducing production costs. Seeking accelerated clinical trials and approvals for advanced therapeutics is on the rise. With many having fast track status designation, it is increasingly critical for innovators to optimize the process and develop an enabling technology that automates and accelerates drug development. Evaluation of new innovative technologies and process platforms across the entire scale-up and production process Gene Therapy Innovation and Product Development Technology Integrators in Cell and Gene Therapy: Increased Efficiency and Standardization The requirements from next generation viral and non-viral delivery platforms for cell engineering Retention of immune cell functionality following complex engineering Challenges of preservation, packaging and logistics needed to be overcome to delivery cell and gene therapies at scale Aired as part of the CPHI Festival of pharma

The extension will add a capacity of over 10 million doses per annum to the site.

Get to market faster with our library of 500+ market ready formulations for Nutritional Supplements, OTC and Beauty

The $30 million investment will enable the site to handle large-molecule programs, with additional capacity for small molecule dosage form development.

Whether you are looking for standalone services or leveraging Catalent’s Follow the Molecule®️ approach for an integrated solution, our experts can help you take your biologic from cell line development through to finished product supply. We have the expertise, experience and advanced technologies to provide you seamless solutions and time savings to get your biologics to clinic or market quickly and reliably.

Data on the first clinical use of lenzilumab in patients with severe COVID-19 pneumonia suggest promising results.

Drug Development Solutions Bioavailability Enhancement Technologies Flexible Manufacturing

Two company sites - one in Canada, the other in Brazil - receive new softgel encapsulation lines to service local customer demand.

Catalent is the global leader in development, delivery, and supply for pharmaceuticals, biologics, consumer health, and animal health products. Integrated analytical and clinical supply services support to accelerate your product to clinic and beyond. Your molecule has so much potential. We share your passion to unlock it.

The CDMO will work on developing a solution and a solid oral dosage form of ViralClear's merimepodib.

Vegicaps® capsules are an ideal solution for consumers seeking an animal free alternative to gelatin capsules. Derived from sustainable red seaweed based carrageenan, our Vegicaps® capsules offer expanded capability to encapsulate a wider range of nutritional products than gelatin based softgels.

Late-stage manufacturing services will be conducted at Catalent’s facility in Anagni, Italy in preparation for large-scale commercial supply of the vaccine

Collaboration includes joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

The expansion includes three high-speed packaging lines — a syringe assembly machine, an auto-injector assembly machine and a top-load cartoner.

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. There are new and exciting capabilities available to help drive innovation and growth in your consumer health business. From new delivery technologies to new materials to new formulations, invest 20 minutes to learn how many different ways Catalent's Consumer Health team can help your OTC or VMS business.

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. The movement towards more plant-based lifestyles that changed the food and beverage market is now changing the dietary supplement market. While the ingredient market is innovating with more plant-based options, the ability to deliver the supplement in a plant-based format is equally important. The consumer trend toward more plant-based solutions Key ingredients & formulations in plant-based supplements How to bring plant-based formulations to market

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. With over 30 years of experience supporting the development of inhaled products and full commercial-scale manufacturing capabilities, Catalent offers complete, end-to-end solutions across all common inhalation dose forms, including DPIs, MDIs, and unit/bi-dose nasal sprays. From early development and device selection through clinical supply, commercial production, packaging, and final product testing, Catalent provides comprehensive inhalation services to help bring more products and better treatments to market faster. Key learning objectives: Understand the latest trends in orally and nasally inhaled therapeutics Learn about Catalent's end-to-end inhalation manufacturing and development services Why partner with Catalent for your inhalation products

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. Speed to first-in-human studies can be challenging for biologics due to their complex nature. Catalent Biologics’ OneBio integrated solution leverages next generation technology, including GPEx® Lightning cell line development, and integrated program management to shorten the timeline to bring biologic therapies to patients. Learn about Catalent’s streamlined approach and latest investments to support pre-clinical to early-stage programs across drug substance, drug product, analytical and clinical supply logistics.

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. As consumer brands look to provide enhanced benefits or more meaningful differentiation, dose delivery technology and format choice offer innovation opportunities. New OptiGel® DR Enteric Release Softgels enable enteric release benefits without the compromise. Enteric release market Existing challenges to enteric release Benefits of new OptiGel® DR softgels

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. Many pre-clinical compounds coming to the market suffer from bioavailability and solubility challenges, which has a significant market on the number of drugs which make it to patients. Increasingly sophisticated technologies for overcoming these challenges are needed to aid the rapid development and commercialisation of drugs - particularly in the realm of speciality products. This session explores approaches and technologies for overcoming bioavailability challenges: Solving complex bioavailability challenges Understand the molecule for bioavailability technology selection & road-mapping Explore advanced technologies to improve speed-to-market Validating a technology selection process - The BioPhorum Technology Roadmap Vision 2.0 Selecting the best technology for your molecule's specific needs

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. The development of dosage forms for oral small molecules is getting more and more challenging due to the increased complexity of molecules and sophistication of the dosage forms that are needed to deliver them to the patient. More and more therapies are being developed by small companies, which can find it challenging to have enough expertise to cover all aspects of development. Enlisting the help of expert partners could increase the likelihood of drug product success. In this presentation, a Catalent expert introduces Optidose™ Design Solution, a new service that combines pharmaceutics, PBPK modelling, manufacturability, material characterisation and patient factors to support decision making during dosage form design, and explains how Catalent's unique insights can help improve data analysis and decision making in order to select the right dosage form for clinical efficacy testing. Review the overall drug development process and why dosage form design is important but challenging Learn Catalent's data-driven approach to address drug development challenges Learn how methodical data analysis can help unlock hidden information Learn how collaboration can help build data with each phase of development

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. The increasing outsourcing trend among pharmaceutical companies represents a promising opportunity for CDMOs. This panel discussion touched upon some of the opportunities, hurdles, and trends ahead for the CDMO market Challenges & Opportunities for the CMO/CDMOs in the Pharmaceutical Industry Strategies/Alliances to Ensure Supply & Manufacturing Regionalised Manufacturing: Pros and Cons Will the CDMO Industry Enjoy Long-Term Benefits from its Role in Tackling the COVID-19 crisis? Market Trends and Services Expected to Register a Significant Growth Future Ahead for CDMOs in the Pharmaceutical Industry Trend outlook 2022