Guest Columns

1. How To Drive Powerful CAPAs With Lean Six Sigma 7/10/2020

   Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.

2. Nitrosamine Impurities In Medicines: What Have We Learned? 7/8/2020

   This article discusses the new EMA report "Lessons Learnt from Presence of N-nitrosamine Impurities in Sartan Medicines," sharing recommendations and the path forward suggested by the European regulators, as well as lessons learned from the GMP sampling, testing, and inspection processes.

3. How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19 7/7/2020

   For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.

4. Culture Media Market Growth Drives Demand For New & Better Technologies 7/6/2020

   With a rise in bioprocessing demand, the market for cell culture media has also seen a surge in the last few years.

5. Is The U.S. Ready For A Re-shored Pharma Supply Chain? 7/2/2020

   In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.

6. ASTM E3219 Standards For Derivation Of Health Based Exposure Limits 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.

7. 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.

8. 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.

9. 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.

10. 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.