Dear Readers,
The United Nations General Assembly adopted the Universal Declaration of Human Rights on 10 December 1948. The 75th anniversary will be celebrated on 10 December 2023, by the time you have read the current issue of the PDA JPST. In Article 27 of the declaration, it celebrates the right to share in scientific advancement and benefits as follows: “Everyone has the right to freely participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.”
As the Parenteral Drug Association, engaged in connecting people, science, and regulation, we are directly involved in this celebration to ensure that we protect these rights and disseminate the parenteral science advancement freely so that the community-at-large is helped. As an editor, I take this responsibility seriously. This brings me to the subject heading – public debate. This journal operates and relies on the peer-review process, the community of experts who evaluate the scientific premise, critically examine the reliability of data and the conclusions drawn from them. This is not a “perfect science,” and errors may creep in inadvertently or experts may be divided on the conclusions presented in a given study albeit based on the data. We at the PDA JPST encourage this debate as you will find in subsequent issues. Having said that, I encourage readers to write letters to the editor. We will make every effort to publish communications that disseminate a scientific issue from a different perspective.
Now coming to the current issue of the Journal, the editorial team has made every effort to bring to you articles of general interest packed with the latest research data.
The first manuscript is a research study presented by Corning scientists on measuring the composition of solution using inductively coupled plasma mass-spectrometry for evaluating the hydrolytic resistance of glass containers. The new technique is offered only as an alternative and not a replacement for the current pharmacopeial methods, which measure the alkalinity of the solution via titration and classify the container as Type I, II, or III based on the titration volume.
We at PDA are concerned about injectables, including prefilled syringes, from production to delivery. The second manuscript in the current issue simulates stopper motion using numerical calculation combined with laser measurements during high-altitude shipment of prefilled syringes. An important issue during the global shipment of medicinal agents.
In the case of cell-therapy products, the compendial sterility test requiring incubation of 14 days is too long and the delay may make a life-or-death difference for a waiting patient. The technology application by Mohammadi, et al., describes a rapid sterility test based on solid-phase cytometry to release short-shelf-life culture media and buffers used in the production of cell-based clinical products. The application report contains validation data comparing the compendial test to the rapid test. I hope you find it useful.
A word about the Journal Editorial Board—we are looking for new members to join our advisory board to help foster a legacy of dissemination of the best and most helpful practices in the production of sterile products. We have done that for the last 75 years and are looking for new members who will help us sustain that legacy moving forward.
I look forward to your engagement and contributions. The success of this journal relies on you!
Best regards,
Shanker Gupta
Accepted Articles
Featured Articles