Sanofi Joins the Speaker Line-Up for SMis Launch, Injectable Drug Delivery 2018
Summary
- Set-up of robust and efficient scale-up that can lead to stable products in the monitored quality attributes The presentation outlines the description of the scientific methodology that consists of several steps.Hear from Sanofi as they will be presenting: Advancements of Fill & Finish Process, on Day 1.Biopharmaceutical manufacturers are under increasing pressure from regulators to ensure the safety and quality of their products.Proteins have a natural propensity to aggregate due to the dynamic nature of their structure, which is held together by a combination of Van der Waals forces, hydrogen bonds, disulfide linkages, and hydrophobic interactions.Jean-René Authelin, Global Head, Pharmaceutical Engineering, Sanofi will be presenting the Keynote Address: "Protein Aggregation and Oxidation During Processing" on Day 1 @13:20.Below is an overview of the session:- Proteins are known to be sensitive to many stresses, including oxidation and shear stress, leading to potentially immunogenic aggregates- Examine the theoretical aspects together with real-life industrial examples that illustrate the possible traps that may be found in the fill & finish processing- Learn which experiments need to be performed in order to understand and predict risks associated with this process- Discover the practical industrial solutions- Hear how to implement these solutions accordinglyFill-finish processing comes after upstream bioprocessing, formation of the active agent by cell culture or fermentation, and downstream purification; this is when the final product has the greatest value, and, thus, the most to lose to a product failure.This includes the formulation, mixing or other preparation of the active agent into its final form, e.g., liquid or lyophilized powder, and filling and sealing within final containers, which increasingly include prefilled syringes and other delivery systems.Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi will also be presenting "Fill and Finish of Biotech Products and Hazards Associated: Derisking Approach" on Day 1 @14:00Below is an overview of the session:- Basic data acquisition focusing on the main physical chemistry properties of the drug product.- Preliminary calculations of process parameters based on prior knowledge using simulation tools in order to anticipate process parameters of freezing, thawing, mixing, filtration and filling parameters.- Set-up of Design space using Lab scale tests for each operation units in order to fine tune the calculation results.- Set-up of robust and efficient scale-up that can lead to stable products in the monitored quality attributesThe presentation outlines the description of the scientific methodology that consists of several steps.www.injectable-drug-delivery.com/prcFor those looking to attend, there is currently a £100 early-bird saving, ending March 29th.SMi presents the Launch of: Injectable Drug DeliveryDate: 16th – 17th May 2018Workshops: 15th May 2018Location: Holiday Inn Kensington Forum, London, UKWebsite: www.injectable-drug-delivery.com/prcSources:http://bit.ly/2sehtvThttp://bit.ly/2FTfW0qContact Information:For all media inquiries contact Pavan Solanki on Tel: +44 (0)20 7827 6048 / Email: psolanki@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities.