CPhI: SPI Pharma talks supply chain challenges

Outsourcing-Pharma (OSP) spoke with John McInerney (JM), general manager of excipients and drug delivery systems for SPI Pharma, about notable developments at the company, what they will be discussing at CPhI Festival of Pharma next week, and what might lie ahead for the pharma ingredients industry.

OSP: Could you please share some of the that have happened at SPI over the past few months?​

JM: We are nearing completion of the construction of a Sorbitol Special manufacturing facility in Grand Haven, Michigan, which is expected to open in Spring 2021 and increase our capacity by over 50%. We have launched four new Mannogem Mannitol product line extensions, and we have new distribution partnerships with Youpuhui in China and DKSH in Japan.

OSP: This is a dynamic industry at any moment in time, but the pandemic has created its own challenges. From your vantage point, how has COVID-19 impacted the pharma ingredients business in specific, and pharmaceutical development and manufacturing in general?​

JM: As you said, the pharma industry is dynamic by nature so we have experience with the need for flexibility and agility. COVID-19 has created some new challenges, in addition to new opportunities, for us. SPI Pharma has always been nimble, so we have been able to quickly ramp production on our cough and cold ingredients, overcome shipping issues, and adapt to the near total shutdown of visiting our customers in person.

Initially, we saw a slowing of new product development at our customers’ level as people were transitioning to working from home. However, since late May, things have returned to their normal pace and even faster in some cases.

OSP: Overall, people in the industry as well as legislators are increasingly concerned about pharma supply-chain challenges (case in point: the proposed Senate bill to mandate examination of the pharma supply chain). What is your reaction to this increased interest in the pharma supply chain?​

JM: Security of supply is an often overlooked and under-recognized risk to the Pharma Industry. SPI Pharma has a history of taking security of Supply very seriously and has actively identified and qualified multiple sources for our critical raw materials; our approach to security of supply is one of the many reasons our customers decide to partner with us.

OSP: With the COVID-19 statement on the SPI Pharma site posted in March, you were among the first industry firms to let the world know your company was on top of it. How has your pandemic plan evolved as the pandemic has progressed? ​

JM: We know that timely, targeted communication is the key during a crisis. SPI Pharma monitored the virus starting in early January for any adverse effects to our supply chain, manufacturing sites, and the shipping lanes.

When it was clear that the virus progressed to a pandemic, our team already had a good understanding of the potential effects to our business and had already begun preparations to ensure continuous operations. In March, we felt it was time to let our customers know that we were ready and prepared. While we worked vigorously to ensure our customers were taken care of, we did not lose sight of our employees’ safety, which is always our top priority; much time and effort were invested in keeping our team healthy so that we could continue to serve yours.

OSP: According to the CPhI site, SPI will be showcasing a number of products. Could you please highlight ones you think might be of interest to OSP readers? ​

JM: We launched the Precious Gem Collection in March 2020 and have seen genuine excitement in the field.

• Mannogem XL Opal, the new spray dried product, brings the security of a compendial mannitol with superior compactability.
• Mannogem XL Ruby is a granular mannitol product that contains that same XL technology and provides significantly better compaction.
• We also launched two new powder mannitol products, Mannogem Emerald and Mannogem Onyx; both have tight particle size distributions and eliminate variability in the process.

The virtual CPhI Festival of Pharma is scheduled October 5-9 and October 12-16. For more information about the sessions, exhibits and other programming, visit bit.ly/345ksGE. ​