Pharmaceutical Process Validation: Product Quality, Safety and Efficacy

Contract Pharma | September 16, 2019

Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step. The result is consistent product quality. It seems straightforward but how does one achieve this when it involves a myriad of multiple systems (PLCs, HMIs, control systems, etc.) and requires a team effort that encompasses people from various disciplines within the plant? First and foremost, it is important to design processes that ensure product quality, safety and efficacy. Today’s software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right way. For instance, these systems can deliver clear documentation, provide version control for the multitude of systems in use and backup to ensure all risks are mitigated. Software systems have become instrumental as validation expands from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, labeling or process control. Quality cannot be adequately assured merely by in-process and finished product inspection or testing. Validation must happen at each step of a manufacturing process, which involves lots of team members from engineers to quality control to compliance officers, etc. to assure that the finished product meets all quality attributes, including specifications.

Spotlight

Research has shown, in mice, that genetic material can be delivered to damaged cells in the kidneys, a key step toward developing gene therapy to treat chronic kidney disease. The potentially fatal condition affects 30 million Americans, most of whom don't realize they have chronic kidney disease.

Spotlight

Research has shown, in mice, that genetic material can be delivered to damaged cells in the kidneys, a key step toward developing gene therapy to treat chronic kidney disease. The potentially fatal condition affects 30 million Americans, most of whom don't realize they have chronic kidney disease.

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Ascentage Pharma Enters into an Agreement with University of Michigan to obtain an exclusive license for Degrader

Ascentage Pharma | November 30, 2020

Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignant growths, ongoing hepatitis B (CHB), and age-related infections, today reported it has gone into a concurrence with the University of Michigan, through which the organization may acquire the selective worldwide rights to a MDM2 protein degrader created utilizing the Proteolysis-Targeting Chimeras (PROTACs) innovation. The medication competitor is as of now entering IND-empowering considers. MDM2 is a critical controller of the tumor silencer p53 and one of the most powerful inhibitors of apoptosis found hitherto. It has high articulation in tumors and assumes a critical part in the event and advancement of tumors. Official to the MDM2 protein with high proclivity, MDM2 inhibitor hinders the MDM2-p53 connections and reestablish the tumor-stifling action of p53.1 Meanwhile, these MDM2 inhibitors present a few difficulties, including portion restricting hematological poison levels, in this manner the pressing need to grow new age of MDM2-focusing on treatments in the therapy of disease. The PROTAC innovation has arisen as another and promising methodology that initiates the corruption of focused proteins through the ubiquitin-proteasome framework (UPS), and it has gotten boundless interest from both mainstream researchers and enterprises since its presentation. Contrasted with ordinary "inhabitance driven" pharmacological methodology, the "occasion driven" PROTAC innovation has numerous focal points, for example, high intensity, high selectivity, with reactant method of activity, and the capacity to target undruggable proteins.2 Prof. Shaomeng Wang, Ph.D., Co-Founder of Ascentage Pharma and Chairman of its Scientific Advisory Board, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, Director of Michigan Center for Therapeutic Innovation, University of Michigan, is a main specialist in the field. Through structure-work investigations of their recently found MDM2 inhibitors utilizing the PROTAC innovation, Dr. Wang's exploration group has gotten intense and viable MDM2 degraders that could adequately actuate fast debasement of MDM2. The lead MDM2 degrader has accomplished total and tough tumor relapse in a xenograft tumor model in mice3. "As a new strategy to induce protein degradation, PROTAC has emerged as a novel modality in drug discovery," said Dr. Wang. "Studies showed, PROTAC-induced MDM2 degradation can not only enhance the potency of MDM2 inhibitors, but also maintain a long-lasting suppression of MDM2 protein levels, providing a new strategy to the treatment of MDM2-driven tumors such as leukemia. We look forward to the further development of the asset by Ascentage Pharma." "The emergence of the PROTAC technology represents another breakthrough in the identification of small molecule drugs. The technology has received tremendous interest for its ability to target undruggable proteins," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We are very pleased to reach this agreement with the University of Michigan, to begin the assessment of this PROTAC-based MDM2 degrader and potentially bring this important addition to our existing pipeline. Through the assessment and potential development of the MDM2 degrader, we hope soon that it will offer an effective therapy for serious unmet medical needs."

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PHARMA TECH

Confo Therapeutics Enters Collaborative Agreement with Regeneron

Confo Therapeutics | December 01, 2021

Confo Therapeutics announced that it has entered into a collaborative agreement with Regeneron Pharmaceuticals, Inc. whereby Confo’s technology platform, which uses conformationally selective VHH antibodies – ConfoBodies® – to stabilize GPCRs in disease-relevant conformations, will be applied with the goal of enabling the discovery of novel therapeutic antibody drug candidates. The agreement will leverage Confo’s expertise in addressing two GPCR targets for which functional antibodies are needed. Confo will be entitled to an upfront payment, research funding, and potential clinical, regulatory, and commercial payments. Further details regarding the agreement have not been disclosed. Confo’s ConfoBody-based technology platform aims to overcome the limitations of drug discovery on GPCRs, the largest and most diverse group of membrane receptors targeted by approximately 30% of all commercialized drugs. “With ten medicines approved by regulatory authorities, Regeneron is regarded in our industry as one of the most effective antibody discovery and development companies, with a successful track record of translating scientific insight into effective and innovative treatments. Working with them underscores the significant potential of our technology platform, in particular our new application to generate antibody drug candidates, and its promise to unveil GPCR drug targets and overcome a range of limitations of current approaches,” Cedric Ververken, Chief Executive Officer of Confo Therapeutics Christel Menet, Chief Scientific Officer of Confo Therapeutics added: “We value this opportunity to showcase the strength of this new addition to our technology suite and participate in what we hope will be the development of successful new antibody-based therapies. Parallel to this, we continue on our own drug development path, and drive innovative small molecule and biological therapeutics into our own pipeline.” About Confo Therapeutics Confo Therapeutics’ unparalleled technology stabilizes functional conformations of GPCRs to uncover a wide range of previously inaccessible drug targets. This platform combined with the pharmacologic and biologic insight it provides, allows Confo to build a multi-indication pipeline of drug candidates with the vision of transforming therapeutic outcomes for patients with severe illnesses lacking disease-modifying treatments. Confo Therapeutics was spun out of Vrije Universiteit Brussel and VIB in 2015. Supported by international life-science focused investors and led by an experienced team of entrepreneurial professionals and scientists from successful biopharmaceutical companies, Confo Therapeutics benefits from the rich scientific and innovative ecosystem in Belgium.

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PHARMA TECH

Saama Launches Active Safety Analytics for Pharma (ASAP), Co-built With Gilead to Transform Safety Surveillance

Saama Technologies, Inc. | October 27, 2020

Saama Technologies, Inc. (“Saama”), the AI clinical analytics platform company, announced today the launch of the new Active Safety Analytics for Pharma (ASAP) product. ASAP is the first validated pharmacovigilance solution to leverage the U.S. Food and Drug Administration’s (FDA) Sentinel Common Data Model and the TreeScan methodology for detecting safety signals. ASAP was co-built with Gilead Sciences, a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Saama and Gilead partnered to develop ASAP, with scientific advice from the Reagan-Udall Foundation for the FDA, and accelerate the life sciences industry’s paradigm shift to adopt active safety analytics.

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