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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: 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

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

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

XS Technologies® Microbial Platform for Protein Expression Brochure

XS Technologies® are the microbial expression systems for today’s therapeutics. While achieving yields of up to 20 g/L for simple proteins and up to 12 g/L for more complex proteins, they merge simplicity and scalability. XS Technologies® Expression Systems can help accommodate industry trends, eliminate production bottlenecks, align downstream processing and drive breakthroughs into the clinic.
Publish Date: 01-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

Streamlined Selection of in vivo Predictive Dissolution Media (on-demand)

Oral administration is the most common delivery method for medicines. If a patient is to get full benefit from an oral medicine, the solid dosage form must first dissolve in their gastrointestinal (GI) fluids, and then permeate across the GI membrane. The efficient development of robust oral drug products requires biopredictive in vitro dissolution methods that can evaluate how the interplay between the drug formulation and the properties of the GI fluid impacts on performance. This webinar focuses on the design of dissolution media to support biopredictive dissolution testing, and highlights a method for selecting practical, physiologically relevant media based upon drug, formulation, and GI fluid properties.
Authors: Deanna Mudie
Publish Date: 29-Sep-2021