Smarter Molecule Development: AI-Driven Tools and Model-Based Approaches in Early-Phase

Follow along for live updates from the Content team as we bring you the latest from CPHI North America 2023 - from session talks, panel discussions, interviews, and more, there's a lot to discover with CPHI Online at the Pennsylvania Convention Center! 

Enabling a healthier world.

The offering will accelerate timelines for the development and manufacturing of molecules and disruptive technologies

A large and increasing fraction of orally administered small molecules in pharma company pipelines have poor oral absorption due to low aqueous solubility or dissolution rate. To address this trend, evaluating formulation approaches for increasing oral bioavailability are becoming routine early on in formulation development programs. Selecting the appropriate technology for your compound requires careful consideration of the compound physicochemical properties, target dose and pharmacokinetic profile, as well as overall market image. In this on-demand webinar, hear about some of the most common bioavailability-enhancing technologies for poorly soluble compounds and a strategic framework for identifying and selecting the appropriate technology. A case study is presented.

The expansion includes the installation of a pilot suite with a 50-L fermenter and automation upgrades to accelerate clinical and commercial projects

Solid-form screening and characterization is a crucial part of drug substance development and pre-formulation. In this webcast, experts will discuss many aspects of solid-form screening including in-silico screening, which can save time and speed up the solid-form development process. A case study will review the in-silico screening of cocrystals of a pharmacophore using hydrogen bond energies and hydrogen bond propensities. A second case study will examine the cocrystallization of nutraceuticals and their versatile use as conformers.

The companies will establish a Centre of Excellence focused on exosome manufacturing and characterization technologies

The new production line at Guangzhou site will supply global and domestic companies with clinical and commercial batches

The European region has historically maintained a prominent role in global off-patent API manufacturing. However, it is apparent that unique constraints are linked to API manufacturing in the European market. In this presentation, we will delve into:
Exploring the challenges and opportunities of off-patent API manufacturing in Europe The significance of fortifying local production capabilities to bolster the European competitive edge in this sector Providing valuable insights that contribute to shaping the future of off-patent API manufacturing in Europe, ensuring resilience at a local level while maintaining global relevance

Tech transfer is a crucial phase that converts clinical promise into commercial gain but pressure on sponsors to reduce time to market in the age of COVID-19 means CDMOs have to be on top of their game to deliver. What are the latest innovations to solve tech transfer challenges?

Rapid and efficient development of drug candidates is increasingly important for pharmaceutical companies with accelerated timelines and funding constraints. However, many early drug candidates have poor oral absorption properties making it challenging to achieve target pharmacokinetic (PK) profiles. Without upfront knowledge of absorption risks and mitigation strategies, poor absorption can significantly impact preclinical and clinical study timelines and costs. Physiologically-based pharmacokinetic (PBPK) modeling software, such as the GastroPlus® platform from Simulations Plus, simulates dynamic physiological factors impacting oral performance. When coupled with in vitro measurements, PBPK modeling is effective in early development for 1) identifying absorption risks, 2) assessing the potential for solubility enhancing formulations such as salts, cocrystals, or amorphous solid dispersions to mitigate these risks, and 3) designing and optimizing preclinical and clinical studies with respect to dose, prandial state, or gastric pH modification to maximize the likelihood of achieving desired PK profiles. In this presentation, we will demonstrate how PBPK models combined with Lonza’s custom and off-the shelf in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development, reducing the need for drug product reformulation or repeated preclinical or clinical studies. Key Learning Objectives: Learn how PBPK modeling can identify potential oral absorption risks and mitigation strategies (e.g. bioavailability enhancement) for early drug candidates. Learn how PBPK modeling coupled with in vitro testing can guide early selection of drug form and formulation to achieve clinical study goals. Gain insights into how key drug and formulation factors including solubility, permeability, and dissolution rate can impact absorption risks such as poor oral bioavailability, food-drug interactions, and pH-dependent DDI effects.

Opportunities for contract development and manufacturing organisations (CDMOs) in China continue to grow but many questions remain over what the future of the sector will look like in the world's second largest pharmaceutical market.

Explore the series of Learning Labs at CPHI North America across several product innovation categories in which thought leaders at our exhibitors showcase their extensive expertise in all areas of the pharma supply chain, offering industry insights across drug manufacturing, outsourcing, pharma ingredients, drug delivery and packaging.

The expansion of mid-scale capacity will enable the company to offer a smooth transition between early-phase and large-scale commercial production

While the COVID-19 pandemic has created even greater demand for partnerships, CDMOs need to be aware that the needle has shifted, creating both opportunities and challenges and changing how the services industry does business

Drug substance production line expected to be operational by end of 2021 as part of CDMO’s expanded collaboration with biotech