Catalent

In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with orphan drugs will be included, with insights on how drug sponsors of all sizes work with contract development and manufacturing organizations (CDMOs) to achieve their goals.

The development of orally administered small molecules is becoming more challenging as an increasing number of molecules in pipelines have poor aqueous solubility and bioavailability.

Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules. For selecting the most suitable formulation technologies in early-phase development, formulation scientists regard efficacy, safety, bioavailability and stability as their top priorities. However, an early-phase formulation strategy should also consider scale-up and manufacturing challenges that may arise later in development. If bioavailability and manufacturing challenges are not addressed in early development, the cost and overall timeline of the project may be negatively impacted. Therefore, developing a bioavailable formulation that is easy to scale-up with superior dose uniformity is imperative for a product’s success.

Webinar Date/Time: Tue, Apr 18, 2023 11:00 AM EDT

Webinar Date/Time: Tue, Apr 4, 2023 11:00 AM EDT

Webinar Date/Time: Thu, Mar 30, 2023 11:00 AM EDT

Catalent’s recent completion of a $30 million (€27 million) project at its facility in Limoges, France, transformed the site into a European center of excellence for biopharmaceutical development, drug product fill/finish services, and packaging. The site further expand Catalent Biologics’ global network, with early phase integrated clinical development through to clinical supply services and small-scale commercial manufacturing, allowing seamless tech transfer of projects as they progress to late-stage and larger-scale commercial supply from other Catalent manufacturing facilities in Europe and North America.

Webinar Date/Time: Thu, Mar 23, 2023 11:00 AM EDT

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.

Tuesday, October 11, 2022 at 11am EDT | 10am CDT | 8am PDT Learn how integrated formulation and clinical manufacturing expertise, as well as strategic partnerships between CDMOs and CROs, can help achieve flexible and efficient first-in-human studies, fast development of challenging molecules, and reduced clinical development timelines and costs, all while increasing success rates.

Catalent’s global network of manufacturing and packaging facilities provide the capacity for efficient commercial supply of orphan, niche and low-volume drugs, which require agile, flexible and strategic solutions.

Catalent’s flexible global manufacturing network supports products throughout their lifecycle, from clinical to commercial supply.

Thursday, April 21, 2022 at 11am ET | 4pm GMT | 5pm CET This webinar will discuss risk mitigation strategies used to address common challenges during spray dried powder development and give insight into the impact of spray drying on powder properties in terms of manufacturability and downstream processability.

Biopharma 4.0 is fundamentally changing the way that manufacturers do business. It will enable better products produced faster, with consistent high quality at a reduced cost. The process of moving from silos of automated or semi-automated processes (Biopharma 3.0) to a fully connected enterprise comprised of smart things is a journey that many manufacturers are only just beginning. Tune in to learn more on the latest status and impact that Biopharma 4.0 has on biopharmaceutical manufacturing.

Catalent’s OptiDose Design Solution integrates pharmaceutics, critical CMC and DMPK parameters, and dose form design target patient characteristics to create differentiated treatments that are successful for innovators, patients and healthcare professionals.

The Boston, MA facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site has over 20 years of experience in inhalable dry powders and Catalent is the only CDMO globally to offer end-to-end spray drying, powder encapsulation and blister packaging capabilities from development through clinical and commercial manufacturing. This video tour showcases Catalent Boston’s manufacturing operations as well as on-site analytical support services.

There continues to be a rapid expansion in the orally inhaled therapeutic pipeline, underpinned by scientific, technological, manufacturing and regulatory advances across drug products and devices. In this Q&A article, Catalent experts Carolyn Berg and Carla Vozone discuss innovations in orally inhaled drug products, in particular dry powders for inhalation.

Thursday, February 24, 2022 at 11am EST| 8am PST| 4pm GMT|5pm CET This webinar will discuss the challenges, opportunities, and advantages of intranasal drug delivery and why it has drawn increasing interest as a route of administration. *** On demand available after final airing until November 18, 2022.***

One of the challenges facing gene therapy manufacturing is the lack of standardization in the process. Standardized methods, materials, analytics, and documentation can help reduce supply chain bottlenecks, increase efficiencies and lead to accelerated development timelines and smoother regulatory filings. In this podcast, we will discuss how Catalent is working to simplify the supply chain, develop processes scalable for late-stage and commercial needs, and accelerate timelines for production of clinical materials

Thursday, January 27th 2022 at 11AM EST | 4PM GMT | 8AM PST In this webinar, experts provide an overview of the needs of different patient populations, and examine the common challenges leading to non-compliance. The experts also discuss how an orally dissolving tablet (ODT) provides a solution to address patient challenges and enables potentially more successful treatments.

With more than 30 years’ experience, Catalent offers end-to-end solutions for multiple inhalation dose forms.

Catalent is a global leader in clinical supply services with flexible solutions for small molecules, biologics, and cell and gene therapies, including integrated services to accelerate products to the clinic.