BIO From The Editor and Guest Columns

  1. Data Integrity, Deviations, And Shop Floor Quality

    Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.

  2. Writing Bulletproof SOPs: Best Practices For Life Sciences Companies

    Writing and enforcing standard operating procedures (SOPs) is a challenge. Poorly written SOPs are a common cause of deficiencies and observations cited in 483s and warning letters from the FDA.

  3. Market Access Impediments: Where Should Biosimilars Go From Here?

    Biosimilars were touted as a payer’s tool to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million).

  4. Integrating Risk Management Into Your QMS — An Essential Toolkit

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.

  5. An Introduction To Liposome Processing For Drug Delivery

    Discovered in 1961, liposomes have been around for several decades as a drug delivery platform that has achieved varying levels of applications and popularity. With their biocompatibility and well-understood chemistry of encapsulation of a wide variety of APIs (active pharmaceutical ingredients), liposomes make it through the screening process for many potential products.

  6. Rethinking The Role Of Packaging Design In Drug Development

    Packaging is an important component in the development of various drugs, as it can greatly affect drug stability and safety. Packaging material is chosen on the basis of its efficacy and other characteristics that enable it to preserve the quality, potency, and safety of the pharmaceutical products. As the industry evolves, packaging is becoming more important both to the successful marketing of products and to the health and safety of patients. As a consequence, there are more reasons than ever to include packaging considerations early in the drug development process.

  7. In-Process Bioburden Testing Of Pharmaceuticals: The Story Behind The Data

    This article looks at in-process bioburden testing and the importance of establishing accurate data and routinely monitoring the data for adverse trends.

  8. Cross-Sector Intelligence: The Prospects For Data Convergence In Biopharma

    This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.

  9. BioPhorum: User Requirement Spec For Small, Flexible Filler Technology

    Members of the BioPhorum Fill Finish group discuss the specific needs that led to the development of the recently released user requirement specification document for small, flexible filler technology; important requirements the document specifies; how the document will benefit industry stakeholders; and next steps for the initiative.

  10. Quality Risk Management 101: Required Reading For QRM Practitioners

    Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. This article focuses on selected publications addressing general, rather than specific, applications of QRM.