Aldevron accelerates growth using operations research in biomanufacturing

In the biomanufacturing industry, production and planning decisions are often challenging because of batch-to-batch variability and uncertainty in the production yield, quality, cost, and lead times. To improve biomanufacturing efficiency, a multidisciplinary team of researchers collaborated over five years to develop a portfolio of decision support tools. The tools developed provide a data-driven, operations research–based approach to reduce biomanufacturing costs and lead times. These decision support tools comprise multiple deterministic and stochastic optimization models to optimize production and planning decisions. To optimize production decisions related to fermentation and protein purification, optimization tools were developed to provide a decision support mechanism that links the underlying biological and chemical processes with business risks and financial trade-offs. To optimize planning decisions, interactive scheduling and capacity planning tools were developed to enable efficient use of expensive and limited resources. Although developed in collaboration with Aldevron, these tools address common industry challenges, and they have been shared with a wider industry community through working group sessions

Aldevron accelerates growth using operations research in biomanufacturing

In the biomanufacturing industry, production and planning decisions are often challenging because of batch-to-batch variability and uncertainty in the production yield, quality, cost, and lead times. To improve biomanufacturing efficiency, a multidisciplinary team of researchers collaborated over five years to develop a portfolio of decision support tools. The tools developed provide a data-driven, operations research–based approach to reduce biomanufacturing costs and lead times. These decision support tools comprise multiple deterministic and stochastic optimization models to optimize production and planning decisions. To optimize production decisions related to fermentation and protein purification, optimization tools were developed to provide a decision support mechanism that links the underlying biological and chemical processes with business risks and financial trade-offs. To optimize planning decisions, interactive scheduling and capacity planning tools were developed to enable efficient use of expensive and limited resources. Although developed in collaboration with Aldevron, these tools address common industry challenges, and they have been shared with a wider industry community through working group sessions

Monoclonal Antibodies

Monoclonal antibodies are established in clinical practice for the treatment of cancer, and autoimmune and infectious diseases. The first generation of antibodies has been dominated by classical IgG antibodies, however, in the last decade, the field has advanced, and, nowadays, a large proportion of antibodies in development have been engineered. This Special Issue on "Monoclonal Antibodies" includes original manuscripts and reviews covering various aspects related to the discovery, analytical characterization, manufacturing and development of therapeutic and engineered antibodies

Drug development progress in duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD) is a severe, progressive, and incurable X-linked disorder caused by mutations in the dystrophin gene. Patients with DMD have an absence of functional dystrophin protein, which results in chronic damage of muscle fibers during contraction, thus leading to deterioration of muscle quality and loss of muscle mass over time. Although there is currently no cure for DMD, improvements in treatment care and management could delay disease progression and improve quality of life, thereby prolonging life expectancy for these patients. Furthermore, active research efforts are ongoing to develop therapeutic strategies that target dystrophin deficiency, such as gene replacement therapies, exon skipping, and readthrough therapy, as well as strategies that target secondary pathology of DMD, such as novel anti-inflammatory compounds, myostatin inhibitors, and cardioprotective compounds. Furthermore, longitudinal modeling approaches have been used to characterize the progression of MRI and functional endpoints for predictive purposes to inform Go/No Go decisions in drug development. This review showcases approved drugs or drug candidates along their development paths and also provides information on primary endpoints and enrollment size of Ph2/3 and Ph3 trials in the DMD space