Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
News|Videos|April 4, 2025
Industry Outlook 2025: Evolving Pipelines and Supply Chain
Author(s)Susan Haigney
Pharmaceutical Technology® spoke with Krishna Kanumuri, CEO of Sai Life Sciences, about which trends from 2024 will carry over and impact the bio/pharma industry in 2025.
Advertisement
In the post-COVID world, pharmaceutical companies have been looking to reconfigure their supply chains and work with global partners, according to Krishna Kanumuri, CEO of Sai Life Sciences. “I think people are looking for the next-generation partners they need [for their] business, which is a challenge, both for providers as well as customers, because customers need to develop new relationships, need to get [these up to speed], and still need to deliver on their programs,” Kanumuri says.
“I think [the] pharma industry itself is looking at what their pipelines [will] look like going forward,” Kanumuri says. “If you look three, four years back, pharma was talking about gene therapy, cell therapy. But right now, thanks to GLP-1s [glucagon-like peptide-1], I think the three main modalities which are getting very exciting at this point are peptides, oligonucleotides, and ADCs [antibody drug conjugates], along with small molecules which seem to be back, and also the fact that all these modalities, about 80% of the work is actually small molecules.”
Click the video above to watch the full interview.
About the speaker
Krishna Kanumuri is CEO of Sai Life Sciences.
Advertisement
Related to this article
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
The FDA has approved remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
Advertisement
Advertisement