Guest Columns

  1. How Will USPTO Guidance Revisions Impact Biosimilars?

    Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO). 

  2. A Patient-Centric Approach To Increase Recruitment And Retention In Clinical Trials

    Good recruitment and retention is critical to the success of clinical trials. Get it right, and a trial will likely achieve its primary objective; get it wrong, and the time, effort, expense, and any patient participation is likely wasted. This article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies get it right the first time.

  3. An Introduction To Centerlining For Pharmaceutical Manufacturing

    Many pharma companies struggle to strike the right balance between enough preventative maintenance and not too much corrective maintenance for manufacturing equipment, and to achieve that balance at a reasonable cost. One method known to drive the preventative/corrective ratio in favor of preventative maintenance is centerlining.

  4. Calculating Sample Sizes For Human Factors Studies: What’s The Magic Number?

    Although sample sizes for medical device usability testing are mostly defined by regulatory standards, it is important for manufacturers to understand the underlying principles, and to make sound decisions accordingly.

  5. Cleaning, Sanitizing, Sterilizing, Or Wishing It Away: What Are We Doing To Control Bioburden?

    Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.

  6. Merck's Best Practices To Implement Strategic Sourcing Partnerships

    Here are the final five best practices that Merck undertook to effectively extend its capacity through strategic outsourcing which focuses on building a strong foundation with external partners.

  7. The Unique Demands of Cell and Gene Therapy Supply Chains

    Three cell and gene therapy sector SMEs representing industry and academia explain supply chain challenges and viable solutions.

  8. 3 Questions To Save Time And Reduce Stress When Reviewing A CDMO MSA

    Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time consuming and difficult. 

  9. Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

    This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.

  10. Refrigerated Transport For Gene Therapies: Exploring The Pros And Cons

    In the first part of this two-part article, common cryogenic shipping methods for gene therapy products were presented, and pros and cons of each method were discussed. In this part, major refrigerated transport methods of gene therapy intermediates will be addressed.