“The dosing of our first subjects with Lpathomab is a significant milestone, and we are very pleased to begin the development of this important product candidate intended to treat neuropathic pain, which is an area of tremendous unmet medical need,” said Dario Paggiarino, MD, Lpath’s Senior Vice President, Chief Development Officer.
#EMD MILLIPORE SIGMA TRIAL#
The trial will include a total of five cohorts at increasing doses. The trial also aims to establish a maximum tolerated dose for future clinical studies in patients with neuropathic pain. The double-blind, placebo-controlled, single ascending dose trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Lpathomab in healthy volunteers. recently announced that the first cohort of six subjects has been dosed in the Phase I clinical trial with Lpathomab. For more information, please visit Lpath Initiates First-in-Human Dosing in Phase I Trial As part of the global Life Science business of Merck KGaA, Darmstadt, Germany, EMD Millipore offers a broad range of innovative, performance products, services, and business relationships that enable its customers’ success in research, development, and production of biotech and pharmaceutical drug therapies. Life Science subsidiary of Merck KGaA, Darmstadt, Germany. The content is invaluable when filing their drug products, resulting in greater confidence and minimized risk throughout the manufacturing process.”ĮMD Millipore representatives will be available at stand #7K40 at the CPhI conference in October in Madrid, Spain, to discuss the EMPROVE portfolio and these new enhancements.ĮMD Millipore is the U.S. “With these enhancements, customers can continue to rely on the EMPROVE documentation to guide, facilitate, and speed their process of qualifying raw materials from EMD Millipore. “The global pharmaceutical industry adheres to the strictest standards, and risk assessment plays a critical role in supplier qualification,” said Andrew Bulpin, Executive Vice President, Process Solutions, EMD Millipore. This platform provides product information and dossiers for the entire EMPROVE portfolio and enables direct, 24/7 access to the comprehensive regulatory information. This dossier includes elemental impurity profiles that address the ICH Q3D guideline requirements published in December 2014.ĭrug manufacturers have an option to use the new online EMPROVE Suite website.
With greater detail on raw material properties, the new Operational Excellence Dossier helps drug manufacturers design more consistent and predictable processes and quality.
The GxP Dossier is structured according to the new EU guideline 2015/C 95/02 and supports risk assessment and supplier qualification for excipients. These new dossiers help streamline and accelerate the costly and time- consuming information collection and risk assessment process.
In addition to the currently available Material Qualification Dossier (formerly referred to as the Basic Dossier) drug manufacturers can obtain two new dossiers for regulatory information. GMP requirements are fulfilled, as all products are produced in Europe, according to the ICH Q7 guideline. EMPROVE API products provide the quality and regulatory documentation required for active pharmaceutical ingredients.Our manufacturing processes are designed to create products with low microbiological and endotoxin levels. EMPROVE Expert products are specified for higher risk applications, where low microbiological and endotoxin levels are critical.EMPROVE Essential products target moderate risk level applications.The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment: The EMPROVE portfolio includes approximately 400 raw and starting materials used in the manufacture of drug products and includes excipients, process chemicals and active pharmaceutical ingredients.
This was the first regulatory body to formalize risk assessment requirements for pharmaceutical excipients, despite the practice being common in industry. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. EMD Millipore Introduces Enhancements to its EMPROVE® ProgramĮMD Millipore recently introduced enhancements to its industry-leading EMPROVE portfolio of pharmaceutical raw materials.
0 kommentar(er)
