Article
White Papers
Advancing Towards a Universal Platform for iPSC-Based Therapies
Human induced pluripotent stem cells (iPSCs) enable availability of next-generation cell therapies for broader patient population at a faster turnaround time for a variety of disease areas. Two Catalent Cell & Gene Therapy experts discuss the use of iPSCs as starting materials for cellular therapies, including the concept behind a universal platform for iPSC-based therapies.
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Offering Fact Sheet
Drug Product Manufacturing in Limoges – Infocard
Catalent Biologics' Limoges, France site is our European center of excellence for early phase clinical biologics formulation development and drug product fill/finish. The site offers an integrated facility with a small-scale filling line, in-house analytical capabilities, quality control labs, cold storage, and regulatory support.
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White Papers
Integrated Solutions for Advanced Therapies
Drug developers face mounting challenges linked to rapid increases in demand for the complex modalities while also accounting for the need to drive process efficiencies at scale. Working with the right partner, that offers integrated services, can help ease the increasingly common problems with scale, access to high-demand raw material, viral vector production, and quality requirements.
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Video
Catalent Cell & Gene Therapies – Changing the Healthcare Landscape
Summary: Catalent Cell & Gene Therapy experts spoke with American Pharmaceutical Review to discuss how cell and gene therapies are changing the healthcare landscape and what needs to be done to bring these advanced therapies to patients.
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White Papers
Leveraging Novel Analytical Approaches for Advanced Therapies
Catalent has developed a relative potency bioassay using quantitative polymerase chain reaction (qPCR) to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay platform can be used to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency for CGTs, mRNA- and other nucleic acid-based therapies.
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Article
Biopharma 4.0 – Spearheading Digital Transformation in the Biopharmaceutical Industry
Summary: 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.
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Offering Fact Sheet
Biologics Analytical Services - ADC
Catalent Biologics provides characterization and GMP support for a full spectrum of biologics including advanced modalities, such as cell and gene therapies, mRNA, and antibody-drug conjugates (ADCs). Our comprehensive, standalone analytical services for ADCs are conducted by our in-house experts and tailored to meet your needs, regardless of scope or phase.
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Webinars
Webinar: ADC’s are back stronger than ever: how, why & what’s next
Summary: Mike Riley, President, Catalent Biologics, will discuss the latest trends in ADC discovery and development, with a focus on how next generation pipelines are being shaped by payload and linker chemistry innovations, including those from Catalent’s award-winning SMARTag® ADC platform.
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Executive Summary
The Keys to Success when Switching from Vials to Prefilled Syringes and Intravenous to Subcutaneous Formulations for Biologics
This article describes the benefits of transitioning from IV to SQ administration, considers the advantages of using PFSs, and explores challenges and solutions for transitioning from vials to PFS.
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Webinars
Leveraging Post-Translational Modifications & Bio-Functional Assays for Characterization of Charged Variants
During this webinar, Catalent experts will discuss challenges associated with charged variants of biotherapeutic products, including monoclonal antibodies and fusion proteins.
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