Guest Columns

1. Introduction To The ASTM E3219 Standard Guide For Derivation Of Health Based Exposure Limits (HBELs) 7/1/2020

   The procedures outlined in the newly published HBEL standard are expected to greatly aid professionals in the derivation of acceptable levels of carryover and should be used in the risk assessment of cleaning processes using the ASTM E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation.

2. Maybe Biosimilar Applicants Should Dance After All 6/30/2020

   The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.

3. A Brief History Of Parenteral Process Validation — How We Got Here 6/29/2020

   Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

4. Are We Adequately Assessing U.S. Pharma Supply Chain Risks? 6/26/2020

   There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

5. Key Engineering & Facility Considerations For Liposome Manufacturing 6/24/2020

   This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.

6. Old Drug, New Tricks? How The BPCIA Could Increase Generic Competition For Insulins 6/23/2020

   High demand, few suppliers, and soaring prices point to the need for more generic competition in the insulin market. This article discusses recent changes to the legal and regulatory framework governing insulin approval that might facilitate such entry.

7. Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness 6/22/2020

   Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you'll want to avoid when dealing with OEE.

8. 4 Preparatory Moves For A Post-COVID World 6/19/2020

   While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.

9. Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned 6/17/2020

   IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S. 

10. A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided 6/15/2020

    Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?