Catalent

The development of biologics, from initial molecule selection to commercial product, presents complex challenges related to stability, manufacturability, and immunogenicity. Skipping essential risk assessments can lead to costly consequences, including reformulation, reduced shelf life, additional testing, regulatory delays, or even project termination. Download this article to learn more about how a structured, data-driven developability workflow can de-risk biologics during early stages of development.

Catalent’s GPEx® Lightning platform now integrates HEK cell line development, delivering faster timelines, higher titers, and consistent product quality for complex biologics. By combining precise genome engineering with high-throughput screening, the system accelerates cell line creation from months to just four, even for difficult-to-express proteins. This paper expands on the platform’s proven CHO capabilities, offering developers a robust, scalable solution for next-generation therapeutics from discovery to GMP manufacturing.

This scientific poster showcases how GPEx® Lightning enables precise, digital control of gene expression for complex biologics. By leveraging targeted integration into ~200 Dock sites and a single optimized construct, developers can fine-tune gene ratios for co-expression of enzymes, cofactors, and multi-chain proteins. Learn how this approach streamlines screening, boosts titers, and shortens timelines—even for products with unknown stoichiometry.

Discover how Catalent’s GPEx® Lightning platform revolutionizes cell line development for complex biologics. This executive summary highlights how the platform enables rapid, high-titer expression of multispecific antibodies and other challenging proteins—accelerating timelines, improving production efficiency, and supporting commercial-scale manufacturing. Learn how tunable expression and digital control empower your team to overcome development bottlenecks and drive innovation in next-generation biologics.

This whitepaper explores biocapacitance measurement as a process analytical technology (PAT) for real-time biomass monitoring in mammalian and microbial systems. Learn how this QbD-aligned approach enhances upstream process control, reduces reliance on post-batch testing, and supports continuous manufacturing. Three real-world applications illustrate its impact on process visibility and efficiency.

Catalent’s GPEx® Lightning platform delivers stable, high-yield cell lines with unmatched speed—achieving titers up to 15g/L for mAbs and 11g/L for bispecifics. With 25-day pool generation and up to 12 weeks saved on development timelines, this offering sheet outlines key performance metrics and benefits that make GPEx® Lightning a game-changer for biologics developers.

Webinar Date/Time: Tue, Dec 9, 2025 11:00 AM EST

Webinar Date/Time: Tue, Nov 18, 2025 11:00 AM EST

Optimized plasmids are vital for viral vector production. Catalent’s off-the-shelf plasmids help AAV gene therapy developers enhance efficiency, reduce costs, and improve consistency across development and manufacturing.

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions. Spray drying has emerged as a powerful and versatile manufacturing technology. It offers significant advantages for stabilizing complex and sensitive drug molecules while optimizing production processes. Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals. This session will cover the latest innovations in spray drying technology, and provide valuable insights into formulation development, process parameters optimization, and large-scale production. Attendees will also learn how to maintain molecular integrity during the spray drying process and leverage in-silico tools to streamline commercialization.

Pharmaceutical micronization plays a pivotal role in enhancing the efficacy and bioavailability of many active pharmaceutical ingredients and the need for robust, repeatable and precise particle size control is critical. This article provides an in-depth review of milling equipment, including jet, pin, hammer, conical and cryogenic mills. Each technique is influenced by material properties like hardness/brittleness, morphology, and moisture content, as well as milling parameters such as feed rate, grinding pressure, mill speed and temperature. By selecting the right milling equipment and optimizing its operation, pharmaceutical innovators can ensure that their products meet the highest standards of quality, efficacy, and safety.

David McErlane, Group President of Biologics at Catalent, shares how integrated expertise in biologics helps simplify complexity, accelerate development, and deliver therapies to patients faster.

Webinar Date/Time: Thu, Oct 16, 2025 11:00 AM EDT

Webinar Date/Time: Tue, Sep 23, 2025 11:00 AM EDT

Webinar Date/Time: Thu, Sep 25, 2025 11:00 AM EDT

Webinar Date/Time: Wed, Aug 20, 2025 11:00 AM EDT

Decentralized clinical trials (DCTs) can be enhanced to achieve greater efficiency, compliance, and patient accessibility, which can be done by implementing direct-to-patient (DTP) clinical supply, especially the pharmacy-led model.

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Webinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST

The right cell line development technology can address production challenges associated with expression and scalability of complex biologics.

Plasmid DNA (pDNA) is a critical starting material used to manufacture viral and nonviral cell and gene therapies (CGT).

Webinar Date/Time: Wednesday, February 12th at 11:00 AM EST

Catalent has developed a cutting-edge bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to measure transcription activity in cells treated with ligands or transgenic vectors. This reliable and reproducible assay is a valuable tool for evaluating the relative potency of various test substances. Enhance your research with Catalent’s robust cell-based potency assays.

Transcriptional activity within a cell can be used to evaluate cell response to a ligand or promoter activity within a transgene or plasmid within a cell. Catalent has developed a relative potency bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay utilizes two fluorescent dyes with minimally overlapping emission spectra that allow real-time monitoring of the gene expression of both target and normalizer genes. The assay does not require purification of the mRNA produced by the cells once lysis has occurred. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows response curve to be generated and compared to a reference standard. The generation of a four-parameter fit curve analysis from raw qPCR cycle threshold data allows for comparison of relative potency and assessment of suitability based on curve parallelism. The assay platform has been used by Catalent to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency.

The manufacture of protein-based drugs is complex and relies on using biological host systems. This can result in small changes in protein structure during production and formation of protein variants that can have a large impact on functionality. This heterogeneity — variations in the protein size, charge or structure — can significantly impact the safety and activity of the final biotherapeutic or biosimilar therapy, potentially hindering their beneficial effect. It is vital that charged variant profiles of biologics are adequately characterized, as many post-translational modifications (PTMs) may alter the charge of the molecule, in turn impacting its stability, pharmacokinetics and pharmacodynamics. In this article, Catalent explores protein variants, focusing on charged variants, by outlining their impact on protein-based drugs, and explain how specific characterization techniques can be used to determine product safety and efficacy.

Transcriptional activity within a cell can be used to evaluate cell response to a ligand or promoter activity within a transgene or plasmid within a cell. Catalent has developed a relative potency bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay utilizes two fluorescent dyes with minimally overlapping emission spectra that allow real-time monitoring of the gene expression of both target and normalizer genes. Notably, the assay simplifies the process by eliminating the need for mRNA purification, enabling more efficient and accurate analysis. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows the response curve to be generated and compared to a reference standard. The generation of a four-parameter fit curve analysis from raw qPCR cycle threshold data allows for the comparison of relative potency and assessment of suitability based on curve parallelism. Catalent has successfully implemented this assay platform to develop a reliable, accurate, and specific bioassay. It stands out for its linear response and reproducibility, making it a valuable tool for evaluating the relative potency of various test substances. Join us to explore how these robust cell-based potency assays can enhance your research and provide critical data on drug product potency.