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FDA Seeks Comment On ICH Q9(R1) Quality Risk Management

ICH has revised Q9 Quality Risk Management, and it provides principles and tools for quality risk management that can be applied throughout the product life cycle of drug substances, drug products, and biological and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. Submit comments by July 15, 2022.

EDITOR'S DESK

IPSCs For Democratized Cell Therapy
Dr. Daniel Teper and his team at Cytovia Therapeutics have developed a unique combination of candidates designed to improve access to safe and affordable "off-the-shelf" cell therapies. Founded just four years ago, the company is preparing multiple clinical trials of IPSC-derived therapies, which Dr. Teper says lend to a consistent, scalable manufacturing process.

Differentiation Via Developmental Difficulty

By way of its business strategy, Context Therapeutics willfully embraces difficult breast, ovarian, and endometrial oncology development projects. That’s what creates differentiation and value in a therapeutic area that’s desperately lacking both, says VC-turned-CEO Martin Lehr.

Will Anellovirus Vectors Solve Immunogenicity Challenges?

Ring Therapeutics is building a first-of-its-kind viral vector platform based on a commensal virus that flies under the immune system’s radar. If its odds-beating CEO is any indication of its success, the company just might beat the immunogenicity challenge.

Engineering Antibodies To Suppress Severe Allergic Reactions

Dr. Jessica Grossman’s life’s work has been dedicated to women’s health, maternal health, family health, and inspiring the advance of female leadership in life sciences. She’s paving that path in her current role as CEO at IgGenix, which is pioneering genomically-engineered antibodies for the treatment of severe allergies.

How To Build A Genomic Medicine Biotech

SparingVision CEO Stephane Boissel took the reins of a fledgling, single-asset gene therapy company born of academic research and quickly built a well-funded startup with a deepening pipeline of ocular disease candidates. He told the Business of Biotech how it happened.

GUEST COLUMNISTS

Your How-To Guide For Mold Investigations Using Biofluorescent Particle Counting Systems
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime. There's a better way to rapidly identify potential contamination and even confirm remediation in real time.
FDA Updates Guidance For Investigating OOS Test Results
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.
2022 Outsourcing Trends In Biopharmaceutical Manufacturing
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.
FDA Publishes Guidance For Biopharma Container And Carton Label Design
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
How To Test Master Cell Banks As A Starting Material For Gene Therapies
BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.

BIOPROCESSING WHITE PAPERS

What Is The True Cost Of Not Having An eQMS?
It is safe to assume that no organization that intends to stay in business sets out to manufacture or provide a low-quality product. This is particularly true for highly regulated companies. And yet switching from a manual quality management system (QMS) to an electronic one in order to improve product quality and ensure regulatory compliance remains low in most companies’ list of priorities. In this white paper we discuss the most common “quality pains” I’ve seen among regulated companies and offer some strategies on choosing and executing an eQMS.

Navigating Regulatory And Development Milestones In Biopharma
8/19/2021

This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.
QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1
10/21/2020

Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.
Managing Risk In Single-Use Systems Design And Implementation
2/17/2021

Implementation of SUS can shift responsibilities to SUT suppliers within key areas, including design and sterilization methods that must be controlled and validated.
Nanoparticles Drive The Nanotechnology Revolution
2/26/2021

This paper helps to define nanoparticles, their various uses, and the analytical techniques used for their physical characterization.
Cell Therapy Scale-Up Strategies For Commercial Success
9/30/2020

This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.