05.30.25 -- To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

Throughout the pandemic, painkiller and sedative demands spiked. Drug manufacturers and CDMOs have become critical in efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.

Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.

This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

Discover how early manufacturing risk assessments lay the foundation for technology transfer strategies to promote smooth transitions, mitigate risks, and enhance efficiency.

From early discovery and development through manufacturing and commercialization, our custom solutions can be tailored to every precise need, independent project, or drug development opportunity.

Our team in Japan provides comprehensive services including primary and secondary clinical packaging and labeling, comparator sourcing, cold chain storage, and local and global distribution.