October 2022: From the Editor

Happy autumn! I am writing this a few days before the editors head to Biotech Week Boston and the BPI conference. This is my first travel since January of 2020, and I am eager to see everyone again. As usual, the fall months coincide with our finalizing next year’s editorial calendar. I will be able to share those details (and other BPI news) with you in our next issue.

One major project that came our way a few months ago within our Informa Connect division was to incorporate into BPI a portion of the Institute for Validation Technology (IVT, formerly an Informa business) — and this process is still underway. Within the IVT Network, The Journal of Validation Technology and The Journal of GxP Compliance served the pharmaceutical industry proudly for nearly 30 years as a global knowledge base for validation and compliance professionals in FDA-regulated industries. The corporate decision, sadly, was to discontinue the network, its website, and both journals.

We are excited, however, to be adding a number of the IVT editorial advisors to the BPI advisory board — and at the prospect of publishing more articles on biopharmaceutical and cell-therapy validation and compliance issues. Another strong component of this group is its long-time commitment to industry training activities, a topic that we plan to cover in more depth in 2023. The merged advisory board list on the next page remains a work in progress itself, and it might take us a bit longer to arrive at the final configuration. Our advisors volunteer their time, so the membership always is in a bit of flux as people come and go based on the amount of time they have to work with us. In BPI’s next two or three issues, we look forward to introducing our new members personally.

Even though BPI and IVT both have existed within our division, our staffs were separate and our websites were built on entirely different platforms. Our primary concern was to preserve the content and thereby the legacy of the IVT Network before that site and its two journals were discontinued — both having been exclusively digital for years. The IVT Network also maintained a dynamic number of podcasts and webinars that we also did not want to lose. Meanwhile, a redesign of our own BPI website currently is in early planning stages, which throws another logistical complication into the works. In publishing, content is our valued intellectual property, so we needed a way to preserve as much as we could. Much of the archived content is relevant to the pharmaceutical industry in general and therefore outside BPI’s usual subject matter area — but we are delighted to have kept access to it all.

We have made good progress thus far. In July of this year, our web team archived the full set of IVT podcasts on the BPI website here: https://bioprocessintl.com/manufacturing/validation/ivt-network-podcast-archive. The team also was able to archive full articles from the past two years of both JVT and GXP in PDF form on our website:

• https://bioprocessintl.com/manufacturing/validation/ivt-journal-archive
• https://bioprocessintl.com/manufacturing/validation/ivt-gxp-journal-archive.

Most IVT articles from before January 2020 remain available on request, and we hope to give them a home (also in PDF form only) when our new website is ready. One unfortunate aspect of this merger of two sites and their different platforms is that we cannot make the PDF-only articles appear in search engines. So you will need to find them by volume and issue, which most reference citations still include. Our initial concern is that those articles be citable and easy to find. For now, we have a workable solution to include them with BPI articles that reference them case by case. With so much of this being a work in progress, other options could arise as we move forward.

BPI welcomes this opportunity to bring you more discussion of life-science validation strategies and regulatory compliance. Our core focus remains on biopharmaceutical and biotherapeutic development and manufacturing — that will not change — but we’re happy to share relevant compliance information from broader pharmaceutical industry perspectives. As appropriate to BPI’s readership, these additional perspectives will help us present information to encourage further industry collaboration and continue to do our part in driving innovation.