EDITOR'S DESK

  • AAV Gene Therapy Takes On Kidney Disease

    Built on the back of Prof. Moin Saleem’s two decades of cellular-level kidney research, Purespring Therapeutics is reimagining the treatment of kidney diseases that affect nearly a billion people worldwide. The company is preparing a first-of-its-kind AAV gene therapy candidate for the clinic. 

CBER’s Peter Marks On Complex Biologics Manufacturing Advances

At ISPE’s 2022 Biotechnology Conference In Boston, CBER Director Dr. Peter Marks kicked off three days of programming with reflections on the COVID-19 pandemic as a catalyst to advanced manufacturing in biologics, sharing his vision for industry and the role of the FDA.

The Coming Wave Of Radio(bio)pharmaceuticals

Convergent Therapeutics is bullish on the combination of radioisotopes and antibodies to direct radiation directly to cancer cells. As enabling technologies improve on previous failures, CEO, CMO, and co-founder Dr. Philip Kantoff is projecting a new wave of activity in the space among biopharmas big and small.

Virtual Event: Overcome Platform Inefficiencies In mAb Manufacturing

Join multifaceted mAb manufacturing experts Gene Lee, CTO at AltruBio and Avril Vermunt, Sr. Director of Manufacturing Sciences & Technology at
EQRx for a discussion on making mAbs more efficiently in the face of rising costs, growing complexity, and constricting cash runways. 

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. 

GUEST COLUMNISTS

  • Your 3-Step Process For Innovation In Precision Medicine

    Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts? 

  • Venture Philanthropy For Duchenne Muscular Dystrophy

    This article reviews a number of these advancements and how diseased-focused venture investing can help drive development of next generation therapies.

  • Your Guide To Producing ADCs That Meet cGMP Expectations

    Antibody-drug conjugates (ADCs) are a diverse class of biopharmaceuticals that combine highly selective monoclonal antibodies specific to surface antigens present on particular tumor cells. Discussion of current good manufacturing practices (cGMP) in this article includes containment, cleaning and decontamination, and manufacturing and purification.

  • Data: The Near Future Of Regulatory Info Management In Europe

    Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.

  • Heightened Standards For Satisfying Written Description In Pharma Patents

    In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.

  • CAPA System Best Practices For GMP Compliance

    A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices. 

  • India’s Biopharma Innovators Tackle COVID-19 Vaccine Supply Worldwide

    This article discusses the roles that Indian biopharmas Serum Institute of India; Biological E, Ltd.; Bharat Biotech; Premas Biotech; and Zydus Cadilla have in supplying North America, Africa, and other regions with COVID-19 vaccines.

  • 3 Strategies For Optimal Oversight Of Your Outsourcing Partner

    Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

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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.

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