11.04.25 -- Will It Not Die? The BIOSECURE Act Back With Iterations

This digital event features industry experts who will share best practices for streamlining processes between sponsors and CDMOs. Register today for free and you can walk away with actionable insights into aligning analytical methods and quality standards to accelerate small molecule production and reduce risk across the development lifecycle.

Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.

In this conversation, Dr. Boro Dropulić, Executive Director of Caring Cross, shares his perspective on regional challenges, opportunities for innovation, and the role of global partnerships.

iPSCs combined with the CRISPR-Cas9 gene editing system can construct or repair mutations and establish highly accurate, controllable in vitro models.

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

To ensure the commercial success of cell therapies, developers must adopt innovative manufacturing and QC technologies that reduce COGS while enhancing scalability, quality, and clinical outcomes.

Understand the growing trend of outsourcing regulatory affairs in pharma, driven by expanding R&D pipelines and the need for specialized expertise to manage product lifecycles effectively.

Here, we evaluated non-viral transfection in primary human T cells, showing that an LNP-based process can co-deliver CRISPR/Cas9 and HDR template DNA in a single payload.

Learn how genome engineering and iPSCs are being used to overcome the critical challenges of durability and host immune clearance in both clinical and preclinical settings for allogeneic cell therapies.

Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

Consolidating logistics, cryopreservation, and storage eliminates handoffs and risk. This single-platform approach creates the consistency needed for global compliance and growth.

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Consider our advanced sequencing protocols and bioinformatics solutions to achieve comprehensive rAAV characterization, ensuring precise analysis of purity, integrity, and identity.

Unearth how pharmaceutical and biotech companies are leveraging new technologies to bring gene therapies to market, making treatments more readily available to patients worldwide.

Access customized end-to-end solutions with our expertise that spans process development, drug substance manufacturing, and aseptic fill/finish, with broad technology for vaccines and CGT.

Our advanced, modular AAV manufacturing platform is continuously evolving to adapt to developer needs and the ever-changing regulatory landscape.

Without clear visibility into your operations, you risk creating blind spots that could result in extended lead times, waste, and quality issues. Watch to learn about the advantages of a modern MES.

Our expanded biologics services and technologies encompass the entire RNA development and manufacturing value chain, helping to deliver your innovation to patients seamlessly.

The AGCellerate LVV offering is supported by our proprietary ProntoLVV™ Platform, which offers a standardized process for full-scale development and manufacturing of viral vectors.

Access a one-stop shop for LNP technologies that provides access to expertise in formulation and analytics for successful outcomes for payload and target applications.