Highly branched, functionalized polymers have potential to act as efficient drug carrier
systems. Dendrimers are ideal candidates among model hyperbranched polymers because of …

Active pharmaceutical ingredient for biotechnology‐based drugs, commonly known as drug
substance (DS), is often stored frozen for longer shelf‐life. Freezing DS enhances stability by …

A monoclonal antibody (mAb) product development case study is presented to address some
of the issues faced during developing a pre-filled syringe (PFS) product for a biotherapeutic…

Dendrimers have emerged as promising multifunctional nanomaterials for drug delivery due
to their well-defined size and tailorability. We compare two schemes to obtain …

Purpose To investigate the cause of unexpected and erratic increase in aggregation during
long-term storage of an IgG2 monoclonal antibody in a trehalose formulation at −20C. …

Chitosan is an important biomaterial used widely in medical applications. One of the key
concerns about its use is the fragile nature of chitosan films. By comparing the component …

Dendrimers are emerging as a relatively new class of polymeric biomaterials with
applications in drug delivery, and imaging. Achieving a high drug payload in dendrimers, and …

Freezing of biologic drug substance at large scale is an important unit operation that enables
manufacturing flexibility and increased use‐period for the material. Stability of the biologic …

Dendrimers and hyperbranched polymers are emerging as potentially ideal drug delivery
vehicles because they provide a significant amount of tailorability and a large density of …

Production of biologics is an expensive process, and to optimize capacity use, bulk protein
solution is often produced in manufacturing campaigns. It is converted into drug product …