Featured Bioprocessing Editorial

51. Expanding RNA-Based Immune Profiling To Immune State 4/27/2022

    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. Expanding RNA-based immune profiling to immune state makes precision medicine more precise.

52. FDA Releases Draft Guidance On CMC For Individualized ASO Therapies 4/26/2022

    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.

53. 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma 4/25/2022

    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.

54. Overcome Potency Assay Development Challenges In Gene Therapies 4/22/2022

    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.

55. Regulatory Requirements For CAR-T Starting Materials 4/21/2022

    As the use of CAR-T therapies continues to grow and the associated regulatory landscape evolves, the consistent application of regulations for both the preparation of starting material and the subsequent manufacture of ATMPs would better serve the patients receiving these treatments. 

56. 5 Ways For Emerging Biotechs To Launch Smarter 4/20/2022

    Biotechs with less than $1B in total sales represent a significant share of new molecular entity market approvals and launches, growing from 10% in 2017 to 30% in 2021. Small and midsize biotech valuations are thus rising, making them less attractive for acquisition and forcing them to launch on their own. These 5 launch strategies can bolster the odds of success.

57. FDA Proposes Updated Guidance On Verification Systems Under DSCSA 4/19/2022

    The FDA is soliciting comments on its proposed update to its "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs" guidance. When a trading partner suspects counterfeit or fraudulent products, or receives a request for verification from the FDA, partners are required to quarantine the product and to investigate its legitimacy. 

58. The Single-use Bioprocessing Bottleneck & Looking Ahead 4/18/2022

    Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.

59. Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions 4/14/2022

    Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.

60. Rare Diseases’ Cost Burden On Patients 4/13/2022

    95% of rare diseases do not have approved treatments or therapies. Patients often bear the brunt of costs directly and indirectly. By understanding the cost drivers that a lack of available treatments poses for rare disease patients, pharma companies can identify unmet needs. Drug developers can improve the cost burden using 3 strategies.