EMD Millipore Introduces Enhancements to its EMPROVE® Program


EMD Millipore Introduces Enhancements to its EMPROVE® Program

EMD Millipore recently introduced enhancements to its industry-leading EMPROVE portfolio of pharmaceutical raw materials. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. This was the first regulatory body to formalize risk assessment requirements for pharmaceutical excipients, despite the practice being common in industry.

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. The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment:

• EMPROVE Essential products target moderate risk level applications.
• EMPROVE Expert products are specified for higher risk applications, where low microbiological and endotoxin levels are critical. Our manufacturing processes are designed to create products with low microbiological and endotoxin levels.
• EMPROVE API products provide the quality and regulatory documentation required for active pharmaceutical ingredients. GMP requirements are fulfilled, as all products are produced in Europe, according to the ICH Q7 guideline.

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. These new dossiers help streamline and accelerate the costly and time- consuming information collection and risk assessment process. The GxP Dossier is structured according to the new EU guideline 2015/C 95/02 and supports risk assessment and supplier qualification for excipients. With greater detail on raw material properties, the new Operational Excellence Dossier helps drug manufacturers design more consistent and predictable processes and quality. This dossier includes elemental impurity profiles that address the ICH Q3D guideline requirements published in December 2014.

Drug manufacturers have an option to use the new online EMPROVE Suite website. This platform provides product information and dossiers for the entire EMPROVE portfolio and enables direct, 24/7 access to the comprehensive regulatory information.

“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. “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 content is invaluable when filing their drug products, resulting in greater confidence and minimized risk throughout the manufacturing process.”

EMD 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.

EMD Millipore is the U.S. Life Science subsidiary of Merck KGaA, Darmstadt, Germany. 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. For more information, please visit www.emdmillipore.com/emprove.

Lpath Initiates First-in-Human Dosing in Phase I Trial

Lpath, Inc. recently announced that the first cohort of six subjects has been dosed in the Phase I clinical trial with Lpathomab. The double-blind, placebo-controlled, single ascending dose trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Lpathomab in healthy volunteers. The trial also aims to establish a maximum tolerated dose for future clinical studies in patients with neuropathic pain. The trial will include a total of five cohorts at increasing doses.

“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.

Lpathomab is an antibody-targeting lysophosphatidic acid, or LPA, a bioactive lipid that has been characterized in the scientific literature as playing a key role in nerve injury and neuropathic pain. Lpath’s preclinical studies showed strong in vivo results with Lpathomab in several different pain models, which suggest that LPA may be an attractive target across a variety of chronic pain conditions, including diabetic peripheral neuropathy, post-herpetic neuralgia, chemotherapy-induced neuropathic pain, and pain associated with lumbosacral radiculopathy. Other preclinical studies have also demonstrated the potential for Lpathomab as a treatment for traumatic brain injury.

San Diego-based Lpath, Inc. is the category leader in lipid-targeted therapeutics. The company’s ImmuneY2 drug discovery engine has the unique ability to generate therapeutic antibodies that bind and inhibit bioactive lipids that contribute to disease. The company has developed four drug candidates, has advanced the first two to mid-stage trials, and built evidence to support its approach of targeting bioactive lipids to treat a wide range of diseases. For more information, visit www.Lpath.com.