CMC Considerations for Successful Early Drug Development (Mar 2023)
March 22nd 2023A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. This eBook provides insights on key approaches and considerations for preparing your program for long-term success.
Developing Optimized Formulations with Minimal Drug Substance
March 22nd 2023Advances in silico and experimental techniques mean that APIs and prototype formulations can be thoroughly characterised using multiple material sparing assays, allowing the most promising formulation candidates to move on to in vivo studies.
Partnering for Success: Strategies to Mitigate Common Pitfalls in Early Drug Development
March 22nd 2023Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound is processed in the body and improve the fate of many of these candidates, improving pharmacokinetic profiles and pharmacodynamic responses. Two Catalent experts discuss the ways companies can address issues with low bioavailability, and the benefits of enlisting an experienced drug development partner.
Optimizing the Path from Pre-Clinical to Clinical Development (Mar 2023)
March 22nd 2023Timely 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.
Strategies for De-risking Early-Phase Oral Small Molecule Drug Development
March 21st 2023Developers anxious to move their small molecule to Phase I may not have the time or resources to fully characterize the druggability of their candidate. Issues that could delay or even derail the program may appear in later clinical studies. Catalent has the resources to characterize lead molecules and develop the best pathway to bring them to Phase I studies and beyond.
Proven Bioavailability Enhancement Solutions for Scalable and Robust Products (Mar 2023)
March 21st 2023Lipid 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.
Optimizing the Path from Pre-Clinical to Clinical Development
December 7th 2022Timely 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.
Advanced Troubleshooting for Spray Drying of Pharmaceuticals
April 21st 2022Thursday, 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: Strategies to implement the latest technologies in biopharmaceutical manufacturing
April 21st 2022Biopharma 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
March 31st 2022Catalent’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.
Catalent - Boston, MA Site Tour Video
March 22nd 2022The 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.
Emerging Trends and Opportunities in Orally Inhaled Drug Products
March 22nd 2022There 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.
Intranasal Drug Delivery: Identifying Challenges & New Product Opportunities
February 24th 2022Thursday, 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.***