Biologic therapies are transforming healthcare, but their complexity brings unique challenges for downstream quality control (QC). Ensuring product purity, safety, and consistency requires precise and reliable analytical methods, especially in the face of regulatory scrutiny. Two critical areas of focus are HPLC protein analytics and residual DNA testing, both of which present technical hurdles that...

Biopharmaceutical development requires a clear understanding of how process conditions affect product quality. For therapeutic antibodies, preserving biological activity—such as antigen binding and effector functions—depends on precise control of cell culture environments. Traditional scale-up metrics like power per volume (P/V), however, often fall short when processes are transferred across facilities or equipment scales. In this...

Join us on Wednesday, November 12th for a forward-looking event exploring the current and next generation of raw materials shaping the mRNA and oligo therapeutics landscapes. This event will bring together industry leaders to discuss advancements in raw materials, including novel enzymes, optimized capping reagents, and other essential materials. We will look at how the...

We are very excited to invite you to the BVS and BioMed Realty Biotech Community Event in Cambridge! Mark your calendars for a great opportunity to connect with industry leaders, explore innovative products, and mingle with fellow professionals in the biotech community. The event will be held at 650 East Kendall Street and all the...

The Regional Biotechnology Conference is an annual conference that attracts more than 100 of the region’s movers and shakers for a half-day of dynamic speakers and topics that are important to start-up and early stage biotech company leaders. This year's conference will feature keynote speakers, Nicholas A. Siciliano, Ph.D., CEO of Vittoria Biotherapeutics. The afternoon...

The minimum-viable-product concept was born not in advanced therapy, but in the tech sector. It asks: What's the smallest set of materials or features required to achieve the desired outcome? This principle can be a powerful guide when sourcing raw materials for gene therapy. Executive Editor Jon O'Connell hosts this Cell & Gene Live event,...

Following the first mRNA-LNP based Covid-19 vaccines, a plethora of new modalities were invented that are directed to treating and preventing diseases in previously unimaginable ways. With these new modalities, both in the field of XNA and their encapsulating modalities (Lipid Nano Particles) standard methods fall short, lacking the resolution, specificity, and adaptability needed to...

A limited proportion of drug candidates ultimately achieve regulatory approval, often due to challenges such as insufficient efficacy, safety concerns, complex or poorly understood targets, limitations in predictive preclinical models, or commercial viability issues. Given the significant cost and time associated with development, early identification of promising candidates and the implementation of a robust development...

Join Stephen Ferrell, Chief Product Officer at Valkit.ai as he provides a critical analysis of one of the most significant regulatory updates to impact pharmaceutical computerized systems in over a decade. The proposed EU GMP Annex 11 revision transforms European compliance requirements from risk-based guidance to prescriptive technical specifications, introducing mandatory audit trails for all...

The oligonucleotide market is moving fast. Now is an exciting time with 20 therapeutics on the market and so many oligos being developed for future treatments. While the market traditionally centred around the outstanding and essential work with rare diseases, some blockbusters are emerging for much larger patient indications. We know that you’re the expert...