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Ensuring Security of Supply and Scalability through CMO Partnerships

We will look at what customers consider key factors in the process of selecting a contract manufacturing organization (CMO) to partner with. Finding the right CMO that can support demand uncertainty is important to Pharma and Biotech customers to ensure adequate supply. When customers launch their molecule on the market, they might decide to launch for a specific indication first but also have plans for label extensions (other indications) with a much higher volume potential. If the demand is increasing, they would need the right partner to support this higher demand. Customers will benefit from multiple scale options from CMO and experience in managing Tech Transfers successfully, as well as optimizing their process to get the best cost of goods sold.
Publish Date: 09-Apr-2021

Gene To IND In 12 Months Without Increased Risk

In this webinar we talk about how Lonza’s advanced platform can achieve speed whilst minimizing risks to achieve the optimal program profile for a seamless transition from gene to IND and beyond. To help companies navigate through this uncertainty, de-risk and accelerate their path to IND, Lonza has created the Ibex® Design solution. The program not only guarantees* timelines to supply tox drug product material in 9 month and GMP drug product for phase 1 trials in 12 months, but also delivers a scalable, commercially viable process. Our subject matter experts in cell line, process and drug product development will walk you through the details and supporting data about how the convergence of technological innovations and 30 years of track record can deliver speed without compromise.
Authors: Abdelaziz Toumi
Publish Date: 09-Apr-2021

Streamlining High Throughput Impurity Analysis in Process Development

In the biopharma industry, there currently is a need to increase production capacity to meet the analytical demands of process development and characterization, which investigate multiple parameters. In this GEN webinar, we will hear about some of the latest advances in high-throughput analytics, with particular attention on the High-Throughput Impurity Detection platform for automated impurity quantitation from Lonza. Additionally, we will hear about some of the unique automation challenges that face biomanufacturers, as well as some novel chemistry and vendor selection methodologies that have been designed to save researchers valuable time and money.
Authors: Hannah Gibbons
Publish Date: 09-Apr-2021

Biologics drug product development: A holistic early stage development approach considering formulation, primary packaging and application

As we see pipelines moving to progressively complex biologics—for example, antibody drug conjugates, bispecific antibodies, fusion proteins and other antibody derivatives—the question of a well designed drug product becomes even more pertinent. As an integrated approach for Biologics product development at the interface of formulation, primary packaging and application is required to ensure that the final Quality Target Product Profile is met, this presentation will showcase the impact of different protein and placebo formulations on particle formation and the functionality of pre-filled syringes, incl. a supporting case study. 
Authors: Susanna Joerg
Publish Date: 09-Apr-2021

Predicting, Avoiding and Mitigating Risk of Failure when Developing Biotherapeutics

Developability issues can contribute to the high attrition rate of potential biotherapeutic candidates. Such issues can arise from manufacturability risks due to post-translational modifications and aggregation, and immunogenicity risks due to the presence of T-cell epitopes. There is a critical need to de-risk the candidates as early as possible during development to improve their success rate. The presentation will describe how in silico and in vitro tools can be employed to highlight, predict and mitigate manufacturability, expression and immunogenicity risks, thereby reducing the risk of failure for the development of biotherapeutics. 
Publish Date: 09-Apr-2021

De-risking the development of biotherapeutics - Early stage in vitro expression and genetic characterisation tools

Attrition rates are high during the early stages of biopharmaceutical development which impacts the cost and time to first in human studies. Identification of the preferred expression host for manufacturing, along with lead candidate screening and material supply can help to optimize for clinical success. As protein therapeutics become more complex, the use of early stage in vitro expression to assess and identify product and manufacturing risks enable the development of process strategies to mitigate these threats as early as possible and maximize the outcome of development efforts. Early genetic assessment of expression cell lines can support cell line characterisation and can help to confirm identify stability concerns. This webinar will describe strategies to mitigate risks, reduce attrition and help improve the quality and safety of your drug candidate.
Authors: Rebecca Michael
Publish Date: 09-Apr-2021

Quality From The Start: Preparing For A Successful Transition From Late Stage Discovery To Clinic

During this webinar, we discuss and explore how advancing an innovative drug from late stage discovery into the clinic is the most-critical step in drug product development. While drug developers would like to gain as much information on the product as early as possible, the scientific focus is on the drug design for optimal efficacy and high safety profile at this stage. This is when key decisions are made that have a long-term impact and pave the way for clinical and commercial manufacturing as well as the future supply chain. In this early phase, it is less about speed,and more important to focus on quality from the start.
Authors: Tristan Wilkins
Publish Date: 09-Apr-2021

Navigating CMC Requirements for Accelerated Development

Chemistry, manufacturing, and control (CMC) activities are critical to the effort of moving promising new drug products to market quickly and efficiently. This summary addresses how careful planning and early integration of an effective CMC strategy, plus choice of the right partner, contributes to project success. A case study is provided to show the results of effective use of these CMC strategies. To learn more, read our executive summary.
Publish Date: 23-Mar-2021

Lung Cancer Treatment by Inhaled Formulations

In this executive summary, we describe formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. A case study is presented in which an approved drug—topotecan—is successfully formulated for DPI administration to the lung.  
Publish Date: 19-Mar-2021

Solid-Form Screening and Rational Cocrystal Design - On-demand

Solid-form screening and characterization is a crucial part of drug substance development and pre-formulation. Knowledge of the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals is essential to establish an understanding of a drug substance and its solid-form throughout the drug development lifecycle. 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 in-silico screening of cocrystals of a pharmacophore using hydrogen bond energies and hydrogen bond propensities. A second case study will examine cocrystallization of nutraceuticals and their versatile use as coformers.  To learn more, view our on-demand webinar.
Publish Date: 04-Mar-2021