Catalent Plans Multi-Phase Expansion of Italian Facility to Increase Biologics Manufacturing Capabilities in Europe 

BioProcess Insider recently interviewed Bernie Clark, Vice President of Global Marketing and Strategy, Catalent Biologics, about the expansion. Read the interview.

Catalent Biologics Launches New GPEx^® Lightning Cell Line Expression Technology

Leveraging Catalent’s proven GPEx^® expression platform in a glutamine synthase knock-out Chinese hamster ovary cell line system, GPEx Lightning combines innovative technologies to further shorten drug substance development timelines. To find out more, watch our recent webinar, “Introducing GPEx Lightning”.

BioProcess Insider recently interviewed Stacey Treichler, Ph.D., Associate Director of Marketing, Catalent Biologics, about the new technology. Read the interview.

Catalent in the News

Catalent Launches New OptiDose^® Design Solution to Help Create Differentiated Treatments

Introducing OptiDose^® Design Solution, a comprehensive assessment of molecule, patient, and market. Designed to incorporate recommendations from our scientific advisors to help drive the dose design decision-making process and create successful treatments.

Catalent Completes Acquisition of RheinCell Therapeutics

RheinCell Therapeutics’ unparalleled induced pluripotent stem cell (iPSC) expertise, combined with Catalent’s broad network, will facilitate innovator companies’ access to high-quality iPSC GMP cell banks.

Catalent Achieves 97% Renewable Electricity Sourcing

Effective July 1, 2021, 97% of Catalent’s electricity usage across its global network is being procured from renewable energy sources such as wind, solar, hydroelectric, and biomass.

Catalent Supports Multiple Partners Through Important Milestones

• DisperSol and Catalent collaborate to establish KinetiSol^® technology manufacturing hub in Somerset, New Jersey, for DisperSol pharmaceutical pipeline. Read more.
• Catalent will supply Edenbridge Pharmaceuticals with a patient-focused fast-dissolve Zydis^® formulation of glycopyrrolate intended for use as adjunctive therapy in the treatment of patients with peptic ulcers. Read the press release.
• Catalent Biologics welcomes the news from Augmenta Bioworks and TFF Pharmaceuticals of positive in vitro data demonstrating binding and neutralization of COVID-19 by their lead mAb, AUG-3387. Catalent has been selected to perform GPEx^® cell line development and drug substance manufacturing scale-up as the program advances through clinical development. Find out more.
• Catalent will support tablet formulation and manufacturing of Curtana Pharmaceuticals’ CT-179, a drug therapy for the treatment of glioblastoma, medulloblastoma, and other brain cancers. Read more.
• Catalent welcomes the news from Bio-Thera Solutions that the first patient has been dosed in a Phase 3 clinical study for BAT2206, a proposed biosimilar of Stelara^® (ustekinumab). Catalent supported this global study from its facilities in Shanghai, China, and Schorndorf, Germany, providing clinical supply management, blinding, labelling, packaging, Qualified Persons, storage, returns and distribution services.

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

Biologics

Webinar | After the Pandemic, Antibody R&D Remains Key | August 26 Victor Vinci, Ph.D., Vice President, Product Development, Catalent Biologics, will give the webinar’s opening remarks.

Biologics UK | London, U.K. | September 6 - 7
Register your participation to connect with Catalent at Biologics UK! Schedule a meeting with our experts to learn more about our biologics capabilities and offerings.

Webinar | Biologics Analytical Methods: Trends and Strategies to Accelerate Biologics Development | September 16
In this webinar, experts will summarize the current bioanalytical landscape and possible strategies to help overcome challenges.

BPI East | Boston | September 20 - 23
Meet with Catalent Biologics experts at BPI East in our booth 808. Aaron Almeida, Manager, Manufacturing Process Optimization, Catalent Biologics, will present “Evaluation of a Next-Generation Downstream Approach to Improve Overall Manufacturing Process Intensity”. Register today.

Cell & Gene Therapy

CAR-TCR Summit Boston | Virtual | August 31 - September 2
Connect with Catalent's experts during CAR-TCR Summit about our expanding cell and gene therapy portfolio from process development to commercial manufacturing. Visit our virtual booth or schedule a meeting to learn more.

Buzz4Bio Connections – Cell & Gene | Gosselies, Belgium | September 15 – 16
Jef Pinxteren, Ph.D., Senior Director of Process and Analytical Development, Catalent Cell & Gene Therapy will present “How to Commercially Scale Allogeneic Therapies” and discuss the challenges, and possible solutions, associated with scaling up allogeneic therapies.

Cell & Gene Therapy Manufacturing and Commercialization | Boston | September 20 - 23
Join us on September 21, 2021, to hear Catalent expert, Nagendra Singh, Senior Scientist, Downstream Process Development, Catalent Cell & Gene Therapy, give an insightful presentation titled, “Evaluation of Novel Affinity Resin with Alkali Stable Ligand for AAV Viral Vectors”.

Knowledge for Growth | Ghent, Belgium | September 27 – 29
Within the “Personalized Medicine” track, Dr. Pinxteren will join the “Beyond the Science” panel session on Tuesday, 28^th September at 3:30 p.m. CET.

Oral Drug Delivery

World Orphan Drug Congress | National Harbor, Maryland | August 25 - 27
Register now to hear Catalent expert, Cornell Stamoran, Ph.D., Vice President of Corporate Strategy and Co-chair of the Catalent Applied Drug Delivery Institute, discuss “Key Considerations for a Patient-First Approach in Orphan Drug Development”. Schedule a meeting with our industry experts during World Orphan Drug Congress USA to learn more.

Webinar | Effective Scale-Up and Technology Transfer Strategies for Spray-Dried Amorphous Dispersions | September 8
Attend this webinar to learn from real-world case studies about best practices and strategies to mitigate risks and ensure a successful tech transfer from development through to commercial-scale spray drying of pharmaceutical products.

Cannabinoid-Derived Pharmaceuticals Summit | Boston | September 21 - 23
Want to learn more about our latest developments and capabilities in oral technologies and manufacturing? Connect with our Catalent experts in Boston who will be available to assist you with your next challenge.

European Paediatric Formulation Initiative (EuPFI) | Virtual | September 22 - 23
Catalent is excited to participate at this year’s EuPFI 2021. Register now and visit our virtual booth or schedule a meeting with our experts to learn more about Catalent’s latest innovations in oral technologies.

Webinar | A Guide to Drug Development of Challenging Molecules | September 23
Experts will discuss some of the key considerations, strategies, and solutions available in the drug development of challenging molecules.

A Catalyst in Drug Development

Todd Stone, Ph.D.
Senior Manager, Analytical & Formulation Development

Dr. Stone is Senior Manager, Analytical & Formulation Development at Catalent’s Bloomington, Indiana, facility. He and his team focus on developing statistically rigorous analytical methods and high throughput formulation strategies using the principles of Quality by Design (QbD). Dr. Stone leads the scientific direction of the analytical and formulation groups ensuring Catalent provides clients with the highest quality data characterizing of the critical quality attributes of their molecules. Access his works including six peer-reviewed articles and scientific posters.

Top Content

Cell & Gene Therapy

• Webinar: “Formulation and Characterization Strategies for Gene Therapies”- Learn about the formulation development considerations for viral vectors, and how to apply knowledge gained from protein formulation development to viral vectors.
• Podcast: “Manufacturing Cell Therapies with an Individualized Mindset” - This podcast focuses on the specialized needs of manufacturing cell therapies at scale, and how custom manufacturing organizations are stepping in to drive process efficiencies and standardization.
• Executive Summary: “Are Real-Time Gene Therapy Test Results Possible?” - Learn how label-free analysis can provide near real-time infectivity measurements and the ways timely, cost-effective measurements help process optimization and scale-up.

Oral Drug Delivery

• Article: “Industry Trend: Examining the Emergence of Unit- & Bi-Dose Nasal Sprays” - Learn how nasal delivery compares with oral and intravenous administration for systemic treatments and the advantages of the nose-to-brain pathway.
• Webinar: “Use of PBPK Modeling for Predicting and Optimizing Controlled Release Dosage Forms”- Experts share how dissolution tools and PBPK modeling can help evaluate whether a molecule is suitable for controlled release applications and predict the effects of release rate on in vitro performance.
• Summary: “Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules” - Understand how to identify critical material attributes, critical process parameter and critical quality attributes of drug products and how to predict their impact on a formulation and manufacturing processes.
• Infographic: “Zydis^® Orally Disintegrating Tablet (ODT) vs. Standard Tablets” – Learn how Zydis^® ODT compares against standard oral tablets through a head-to-head comparison across a wide range of variables and clinical endpoints.

Virtual Site Tours

 Biologics Development and Manufacturing

• In this 360° virtual tour, explore Catalent’s flagship European syringe filling facility in Brussels, Belgium, that provides expertise in technology transfer, scale-up and lifecycle management for your biologics and sterile injectables, including device assembly and packaging.

Clinical Supply Solutions

• In this video, tour the Catalent Clinical Supply Services facility in Schorndorf, Germany, and explore the site’s innovative and flexible end-to-end clinical supply solutions for Europe and beyond, including packaging, labeling, and storage and distribution services for your oral, biologic, and advanced therapy medicinal products.

Oral Development and Manufacturing

• Take a 360° virtual tour to learn about Catalent’s center of excellence for early stage small molecule drug development, in Nottingham, U.K. The site offers an array of services including characterization, formulation and analytical development as well as manufacturing and packaging for oral dosage forms. 

Catalent is Proud to Support Many High-Profile COVID-19 Programs. Join us!

Catalent has been awarded more than 80 COVID-19-related compounds and is on track to deliver over one billion COVID-19 vaccine and treatment doses in 2021. Join us in our mission to help people live better, healthier lives.

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

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