• Gene Cargos: Building A Bigger Ship

    Dissatisfied with the limitations of AAV gene editing, Drs. Ray Tabibiazar and Joe Higgins launched SalioGen, a company with an ambitious goal: the safe delivery of large strands of DNA cargo that mimics the way it happens in nature. 

Who Said mAbs Were Easy?

Under the leadership of CEO Mondher Mahjoubi, M.D., oncology-focused biotech Innate Pharma is developing therapeutic antibodies that harness the immune system to fight cancer. The company is making strides with some next-gen, complex tri- and tetra-specific antibodies—and Dr. Mahjoubi isn't afraid to face the CMC challenges that come with the job. 

Ocular + Auditory Cell Therapies: Lineage Cell Therapeutics 2.0

On the heels of a lucrative deal with Roche/Genentech for its Phase I/IIa dry age-related macular degeneration candidate, Lineage Cell Therapeutics is fording new waters with a promising auditory neuropathy spectrum disorder candidate. CEO Brian Culley shares the strategy.

CAR T-cell Therapy, Vaccines To Address Breast, Ovarian Cancers

In partnership with the Cleveland Clinic and Moffitt Cancer Centers, Anixa Biosciences moves into Phase 1 trials of its innovative approaches to treating and preventing all-too-prevalent cancers in women.

Building A Pipeline On Computational Biology

Fountain Therapeutics is building a pipeline of candidates aimed at reversing cellular aging. To inform the effort, it built an AI-driven computational platform capable of screening tens of thousands of compounds per month.


  • Key Considerations For Decarbonizing Your Biotech Facility

    The manufacturing processes for biopharmaceuticals do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, and packaging and in supplying energy to building systems and indirectly to manufacturing equipment. This article looks at the key considerations you should make when considering decarbonizing your facility and uses a case study with quantification of estimated costs.

  • Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting

    The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.

  • How To Evaluate & Manage Safety Risks In Biopharma

    Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

  • Emerging Trends In Cell & Gene Therapies For Immuno-Oncology

    Survival rates have increased for many cancers over the past two decades, but there remains an unmet need for more effective therapies. This article examines the current state of clinical development, investment, and partnerships for novel immuno-oncology cell and gene therapies.

  • Expanding RNA-Based Immune Profiling to Immune State Makes Precision Medicine More Precise

    A complete model of the tumor biology is showing promise to become a new standard for predicting patient response and helping more patients benefit from the power of immunotherapy.

  • FDA Releases Draft Guidance On CMC For Individualized ASO Therapies

    A new FDA guidance released in Dec. 2021 acknowledges the difficulties inherent in manufacturing individualized antisense oligonucleotide (ASO) treatments and offers researchers and manufacturers the opportunity to create policies and procedures that are more likely to be condoned by the FDA in an IND submission.

  • 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma

    Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.

  • Overcome Potency Assay Development Challenges In Gene Therapies

    In gene therapy development and manufacturing, developing and validating appropriate potency assays that reflect the mechanism of action acceptable to regulators is a process fraught with challenges. The FDA advocates the use of a matrix approach, and this article shares best practices of this approach.


  • Software Automation In The Blood And Biologics Industry

    Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

  • Use Of Maurice CE-SDS In ICH Q6B-Based Biosimilar Comparability Exercises

    The route to market for biosimilars places strong emphasis on the analytical and characterization techniques used to investigate the structure of the molecule and, importantly, side-by-side comparability. 

  • Assessing End-To-End Drug Development Partnerships

    As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.

  • Bridging The Gap: Manufacturing Software And The New Digital Edge

    Core enterprise software systems – MES, ERP, MRP and the like – are vital to the success of most manufacturing operations. Yet they’ve been largely unable to reach the periphery of the factory floor, where business-critical processes like production record creation, review and release take place. This white paper explores the past, present and future of manufacturing tech and how new smart manufacturing applications are extending core systems to deliver a digital edge to production and quality personnel.

  • Navigate The CMC Regulatory Landscape For Cell And Gene Therapies

    The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.




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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