• Navigating A Clinical Hold

    FDA-ordered clinical holds are on the rise, and biologics IND are driving them. Immunome CEO Purnanand Sarma, Ph.D. shares his take on the role of the clinical hold, the biopharma’s appropriate response, and advice on obviating for the circumstance.

The Philogen Family Prepares For Market

In 1996, Prof. Dario Neri and his brothers Duccio and Giovanni founded the biopharma Philogen. Today, three of the company’s 17 clinical-stage programs are in phase 3 trials, seven in phase 2. Prof. Neri offered insight into the company’s academically rooted, metered approach on episode 103 of the Business of Biotech podcast.

Are Fibroblasts Overlooked?

Clinical-stage regenerative medicine company FibroBiologics is studying the use of fibroblasts in regenerative medicine for seemingly obvious applications like degenerative disc disease, but they’re also looking at the cells’ immune response implications in cancer and MS. Are readily-available fibroblasts undervalued in therapeutic research?

The Nuances Of Biopharma Portfolio Management

Lara Sullivan, M.D. leans into the riches of her experience in big pharma R&D as she architects upstart Pyxis Oncology’s deep-and-wide portfolio. She shared much of her insight on the topic during a recent interview on the Business of Biotech podcast. 

Why It’s Computational Biology’s Time To Shine

Astronomical biologic development costs, contracting capital markets, painfully long timelines, and an increasingly stingy regulatory environment are just a few of the reasons computational biology solutions are moving from the “luxury” column to the “survival” column for biopharmaceutical companies. 


  • 3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully

    Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.

  • Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases

    Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.

  • Decentralized CAR-T Manufacturing Reduces Costs & Complexity, Expands Access

    High costs are endemic to CAR-T cell therapy treatments, leading to a large gap in healthcare between those who can afford to pay and those who cannot. However, changes in manufacturing processes — namely decentralizing them — can reduce costs and complexity while also expanding patient access.

  • Biopharma Facility Modular Design & Construction: Key Considerations

    In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.

  • A Practical Guide To Navigate The EU's Revised GMP Annex 1

    The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.

  • CAR-T & Beyond: CGTs In Development In 2022

    There's more going on in cell and gene therapy work than CAR-T. This article reviews the main cell technologies currently being developed in clinical research, including examples of studies being conducted, developers, modes of action, and benefits of the different types of cell therapies. The article also shares insight on how to avoid pitfalls and prepare for rapid market uptake.

  • 5 Steps To Avoid Mismanaging Biopharma Grant Funds

    You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.

  • Qualifying Working Cell Bank Replenishment

    Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. The availability of well-characterized cell banks is imperative to ensure drug product supply. This article shares regulatory tips for cell bank registration and regulatory considerations when replenishing a working cell bank.


  • Analyzing Product Formulation Using Raman Microscopy

    Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

  • Analysis Of Engineering Manufacturing Risk

    Here, we present a manufacturing risk analysis for a novel standardized and modularized single-use manufacturing strategy for 2,000 L scale single-use recombinant protein production.

  • Flexible Platform Solutions Overcome Vaccine Production Challenges

    This paper explores the challenges of vaccine development and how they can be overcome by applying a quality by design (QbD) platform approach from early process development phases forward. The impact of the COVID-19 pandemic on vaccine production is evaluated, with insight on how flexible, integrated, closed-system processing is advancing the future of safe and efficacious vaccine production.

  • Successful Drug Development With Synthetic Lipids: Critical Aspects And Strategies

    Lipid-based drug delivery systems offer several advantages, including improving the stability, solubility, bioavailability, and toxicity profiles of active pharmaceutical ingredients (APIs). It is essential to select the optimal lipid excipients with the appropriate characteristics for each specific API and application and to ensure that they can be produced using high-quality production methods that are scalable for GMP manufacturing. Working with the right supplier that offers consistent, high-quality products and has expertise in the drug development process and the regulatory environment is essential for the successful development and commercialization of lipid-based drug products.

  • Modern Containment Solutions In OSD Processes

    In the containment world for OSD processing we see smaller batch sizes and more changeover, which require greater levels of efficacy, efficiency, and speed. Here we consider the pros and cons between a hard-wall system and a flexible-wall containment systems.




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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