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How to Safely Handle Your Antibody Drug Conjugate

Handling and manufacturing can be challenging due to the strict requirements for containment. This webinar illustrates how, with the help of internal specialized occupational toxicology and industrial hygiene knowledge, we can support the growing business to solve the mystery of safe handling ADCs.
Publish Date: 16-Dec-2021

Confidently assess potential unintended binding and activity of biotherapeutics

There is huge promise in harnessing the immune system, but misdirecting this powerful response can have serious consequences for patients. Even minimal off-target binding can lead to drug development failures, therefore rigorous specificity analysis is critical for success. Long believed to be highly specific, recent data indicate that antibodies frequently (~25%) display cross-reactivity.  As a result, immunosafety assessments through specificity profiling is a regulatory requirement for monoclonal antibodies and other antibody-based biotherapeutics, an area where unfortunately, “standard” in vivo toxicology assessments might lack relevance. In this webinar, we explore the challenges of comprehensively assessing the specificity profile when moving a candidate to first-in-human (FIH) studies, through the application of membrane proteome arrays and cell-based immunotoxicity assays. Case studies will highlight how these in vitro assessments add significant value by predicting risk early and how potential clinical safety issues could have been averted by such a comprehensive approach.
Authors: Noel Smith
Publish Date: 06-Dec-2021

Selecting In-Vitro Dissolution Methodologies For Amorphous Solid Dispersions

Read an article by Life Science Connect about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery. Yet, new drug targets and mechanisms of action continue to drive drug candidates’ physical properties toward poorly soluble biopharmaceutics classification system (BCS) II or IV designation. Applying bioavailability enhancement techniques can help improve not only the water solubility and oral absorption of OSD drug products but also increase patient safety, efficacy, and compliance. With the availability of so many types of in vitro dissolution tests, though, how do you determine which one will be most effective in predicting in vivo performance of your BCS II or IV drug product?
Authors: Deanna Mudie
Publish Date: 16-Nov-2021

Local Treatment of Lung Cancer by Dry Powder Inhaler

For cancer treatment, local delivery is a promising way to avoid unnecessary exposure of healthy tissue to potent anti-cancer drugs. In lung cancer specifically, local delivery via inhalation using a dry powder inhaler may be particularly advantageous to the patient: it is non-invasive, convenient to administer, and requires no clinic visit.  In this on-demand talk, it will be presented Lonza’s approach to formulation and manufacturing of local lung cancer treatments by dry powder inhaler. In addition, discussed two case studies: bevacizumab (a monoclonal antibody) and 5-azacytidine (a small molecule).
Publish Date: 03-Nov-2021

Local Treatment of Lung Cancer by Dry Powder Inhaler: On Demand

For cancer treatment, local delivery is a promising way to avoid unnecessary exposure of healthy tissue to potent anti-cancer drugs. In lung cancer specifically, local delivery via inhalation using a dry powder inhaler may be particularly advantageous to the patient: it is non-invasive, convenient to administer, and requires no clinic visit.  In this on-demand talk, it will be presented Lonza’s approach to formulation and manufacturing of local lung cancer treatments by dry powder inhaler. In addition, discussed two case studies: bevacizumab (a monoclonal antibody) and 5-azacytidine (a small molecule).
Publish Date: 03-Nov-2021

Support for regulatory submission and feedback by applying state of the art in silico and in vitro tools

An understanding of the potential immunogenicity risk of your therapeutic candidate is a key part of pre-clinical development. While human primary cell assays can provide vital data to help support this assessment, the design and qualification of such human in vitro assays is key to generating high quality, reliable data to support regulatory filings. Here we discuss how a panel of healthy donors can be pre-qualified for specific assays and how this donor panel can then be used in studies to assess the immunogenicity risk of therapeutics.
Authors: Noel Smith
Publish Date: 22-Oct-2021

Navigating Bioconjugate Development: Q & A with Lonza Experts

Bioconjugate development continues to be a markedly complex proposition for drug developers, driven, in part, by increasingly intricate, disparate supply chains and a pervasive lack of expertise across the biotherapeutic sector. Iwan Bertholjotti, Director of Commercial Development of Bioconjugates, and Dr. Bernhard Stump, Head of Development of Bioconjugates, recently hosted  a Q&A session after their webinar The Challenges of Moving a Bioconjugate Candidate from Clinic to Market. Here you can read  the questions they addressed from attendees regarding Lonza’s expertise and history in this space.
Publish Date: 14-Oct-2021

Chromatography, Purification & Isolation Technologies

For development and supply with novel active pharmaceutical ingredients, a strong partner with a wide portfolio of technologies is advantageous. In this on-demand webinar you will learn which options Lonza can offer you in the field of chromatography and allied downstream technologies.  It is demonstrated how these technologies are applied to design favorable processes in order to generate true customer benefit.
Publish Date: 06-Oct-2021

Working as One to Advance Your HPAPI to Market

Creating the optimal pathway for your highly-potent small molecule drug candidate through each clinical phase is critical to your success. This webinar explains how to choose the right partner with the right expertise for your HPAPI development journey, from early phase to commercialization through innovation in manufacturing technology and flexible business models. Supported by a case study, we show how Lonza has developed an innovative production offering to accelerate development and provide a more flexible (HP)API supply for customers through the full product lifecycle.
Publish Date: 05-Oct-2021

Can Yeast be the Future of Large Scale and Efficient Subunit Vaccine Manufacturing

Vaccines have been developed at record breaking speeds to fight the COVID-19 pandemic and are already saving lives. To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.
Publish Date: 01-Oct-2021