Catalent

Catalent’s UpTempoSM Antibody combines the industry-leading GPEx® cell line development technology with streamlined, phase-appropriate drug substance development to deliver products from early-stage development through GMP manufacturing. The UpTempo Antibody platform process enables an 11-month timeline from gene to clinic.

https://www.biopharminternational.com/bp_w/accelerate-biotherapeutics

Speed to clinic is a top priority for the majority of biopharmaceutical companies. Harmonizing technological innovation with platform biomanufacturing development and knowledge can address the time and cost barriers for protein biologics while producing stable, high-expressing antibody-based therapeutics. Catalent’s UpTempoSM Antibody platform process combines industry-leading GPEx® cell line development technology with streamlined, phase-appropriate drug substance development to deliver products from early-stage development through GMP manufacturing. In addition, UpTempoSM Antibody provides a flexible platform process for multi-chain expression and scalable manufacturing with consistent performance and product quality – all key aspects to deliver biotherapeutics on an expedited timeline for clinical trials.

How UpTempoSM Antibody addresses key challenges bringing antibody therapeutic programs to clinical trials

What innovative technology and phase-appropriate, scalable bioprocessing developments are applied from gene to GMP batch release

How to deliver high-expressing, consistent antibody therapeutics on expeditious timelines for clinical studies

CEOs, VPs and Consultants of biologic development

Directors of biologic development, bioprocessing, process development and biomanufacturing


Senior Director, Molecular & Cellular Biology
Catalent Biologics

Dr Laura Daley is a Senior Director at Catalent Pharma Solutions, for which she supports Cell Line Development, R&D, and Cell and Molecular Biology activities. Laura received her PhD in Pharmacology and Physiology from Saint Louis University School of Medicine. She has over 16 years of industry experience in stem cell biology and gene editing, and continues to leverage her expertise in developing innovative platforms for protein manufacturing at Catalent.




Senior Director, Process Development
Catalent Biologics

Tyler Gadoury currently serves as Senior Director of Process and Analytical Development at Catalent Pharma Solutions. He has over a decade of clinical and commercial biologics drug substance experience across numerous modalities, working with companies all over the world. Tyler holds a BS in Chemical Engineering, an MBA, and is a certified Lean Six Sigma Black Belt.


Webcasts

Webinar Date/Time: Wed, May 8, 2024 11:00 AM EDT




UpTempoSM Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic

Join experts to discuss the benefit of integrating formulation and manufacturing to enhance drug solubility and market speed with lipid-based formulations and softgels

https://www.pharmtech.com/pt_w/lab-to-launch

Lipid-based formulations (LBFs) and softgel capsules have been shown to improve the bioavailability of poorly soluble drugs while providing a fast and cost-effective path to the clinic and market. However, fully unlocking the potential of this dosage form requires a holistic approach that seamlessly integrates formulation development and soft gel manufacturing. This webinar aims to simplify these complex scientific concepts and shed light on the nuances of LBF and softgels. Experts will discuss the advantages of LBFs and softgels while addressing the ongoing challenges in realizing their full clinical and commercial potential.

Gain insights into the benefits of LBFs and softgels in addressing the challenges of delivering poorly soluble drugs.

Understand how to select appropriate excipients and optimize LBFs.

Discover how an integrated approach can accelerate LBF candidate development and ensure successful translation into clinical products.

Senior Vice President (SVP), VPs, or Directors

Chemistry, Manufacturing, and Control (CMC)


Professor of Pharmacy
University of Southern Denmark

Dr. René Holm is a pharmaceutical expert who received his PhD at the University of Copenhagen in 1998 and 2002. He joined Lundbeck in 2001 and moved to Janssen in 2016. Dr Holm worked in various fields such as physical chemistry, material science, and pharmaceutical development. He has co-authored more than 200 original articles and is currently a professor in pharmaceutical physical chemistry at the University of Southern Denmark.




Senior Manager of Pharmaceutical Development
Catalent Beinheim
Catalent Pharma Solutions

Dr. Guillaume Enderlin is senior manager of pharmaceutical development at the Catalent Beinheim site in France. He worked for 12 years in softgel R&D, from formulation to manufacturing and development processes, building expertise to cover the whole Rx Pharmaceutical Development process. Guillaume is a pharmacist and has a master’s degree in pharmaceutical engineering.



Webinar Date/Time: Wed, Apr 24, 2024 11:00 AM EDT




From Lab to Launch: Successful Drug Development Strategies Using Lipid-Based Delivery Systems

Articles

Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where
the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully
selecting fill formulations during the early stages of drug development, it is possible to meet the specific
requirements for bioavailability and stability for clinical trial and supply.

Advancing Lipid-Based Formulations and Softgels in Drug Development (Feb 2024)

Planning on packaging clinical supplies in Europe but unsure which country will provide the best balance between cost, flexibility and time?

https://www.pharmtech.com/pt_w/clinical-supply-planning

Where is the optimal location to base the packaging and distribution of clinical supplies? This is a question that trial sponsors have been asking for decades. The simple answer is….it depends. The more actionable answer requires examining key study factors that can have a direct influence on clinical supply placement in conjunction with business decision drivers, preferences and even the study drug itself. The real answer is there is no single right country that will be perfect for every sponsor or every clinical trial, but there are ways to evaluate and narrow down the choices to get to the best option.


In this webinar, a clinical supply management expert will take the audience on a tour of Europe. There are two major choices in Europe – countries in the European Union (EU) and those that are geographically in Europe but not part of EU, such as the UK. By the end of the webinar, you can expect to have a better understanding of how to objectively evaluate and ultimately decide whether it is the EU or the UK that best aligns with your clinical supply strategy.

Understand the critical factors that influence optimal placement of clinical supplies

Compare and contrast the fundamental differences between the EU and UK for clinical supplies

Learn to examine various scenarios to better understand which variables most influence country selection

Supply Chain/Logistics/Distribution Management

Clinical Supply/Clinical Supplies Management

 is a Clinical Supply Manager at Catalent and is responsible for end-to-end clinical supply strategy, forecasting and support, including IRT set up and inventory management. With over 20 years in the pharmaceutical industry, her previous roles include preclinical research, laboratory testing and clinical and commercial packaging. Dr Quinn holds a PhD in Molecular Biology & Physiology and a BSc in Pharmacology from The University of Leeds.

Webinar Date/Time: Thu, Mar 7, 2024 10:00 AM EST




European Clinical Supply Planning – Balancing Cost, Flexibility and Time

RT-qPCR is a rapid and sensitive bioassay designed to detect subtle gene expression changes, crucial for evaluating the potency of therapeutic biological products. Join Catalent’s webinar to learn how this technique enhances drug potency analysis, streamlining the evaluation of cell response to ligands and transgenic vectors.

https://www.pharmtech.com/pt_w/novel-biological-responses

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 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.

Discover Catalent’s novel potency bioassay using RT-qPCR to assess relative transcription activity

Understand the advantages and potential limitations of transcriptional assays compared to reporter gene assays

Explore how transcriptional assays compare to ddPCR and flow cytometry for cell and gene therapy analysis


Director, Biologics Analytical Services
Catalent

 joined Catalent in 2007 and is currently a director of Biologics Analytical Services. He oversees cell-based and non-cell based functional assays, including analytical process impurities, at Catalent’s Kansas City location. He has over 30 years of experience supporting biologics analytical sciences, with previous roles at Aptuit and the University of Kansas. Pedro received his Masters in Biochemistry and Molecular Biologics at the University of Austral Chile.


Webinar Date/Time: Wed, Feb 28, 2024 11:00 AM EST





  Best Practices, Strategies & Utilization of Novel Biological Responses for Robust Cell-Based Potency Assays

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. In this presentation, the development of a cell-based potency assay on an automated platform is discussed.

https://www.biopharminternational.com/bp_w/reducing-variability

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to biologic nature, the variable material inputs provide a challenge. Therefore, other aspects of the analytical method need to be assessed for improvement opportunities. Removing variability through automation can help increase assay robustness and ruggedness, as well as reduce time to achieve results. In this presentation, the development of a cell-based potency assay on an automated platform is discussed.

Advantages (safety, performance, quality) of bioassay automation

Comparisons between manual and bioassays automation

*Head or a senior level of management **Head or any level of management

 is the Bioassay Manager at Catalent’s Research Triangle Park location in North Carolina, and oversees assay development and QC testing for cell-based assays, ELISA’s and PCR. He has over 25 years of experience ranging from genomics startup, clinical stage biotech and contract organizations. Previously, he lead a discovery team at Cambrex, and prior to that was at GPC Biotech and Alphagene.



Webinar Date/Time: Thu, Dec 14, 2023 11:00 AM EST



