The Rx-360 consortium has had a profoundly positive impact on pharmaceutical manufacturers and their suppliers. As an international, nonprofit, pharmaceutical supply chain group (established in 2009), its mission is to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain†(1). The list of consortium members (www.rx-360.org/Membership/ListofMembers/tabid/71/Default.aspx) is diverse and presently includes both pharmaceutical manufacturers and suppliers (24 and…
Manufacturing
Regenerative Medicine
The year 2011 may be seen as one in which regenerative medicine entered its adolescence. Public attention — from investors to desperate patients — finally turned toward this nascent industry with something other than skepticism or unrealistic expectations. The FDA’s approval of Dendreon’s Provenge cellular immunotherapy switched on the spotlight, and cell therapy companies suddenly faced a barrage of questions about cost, manufacturing issues, product development, and patient access. US Policy: In May 2011, US representatives Brian Bilbray…
Enhancing Data Quality with a Partly Controllable System at Shake Flask Scale
In bioprocess development, small-scale systems are used to identify appropriate cell lines, media, and feeds before applying more expensive, controlled cultivation systems at larger scales. Process development relies on data generated in such uncontrolled small-scale cultivation systems, so comparability is an issue. Shake flasks are commonly used for small-scale culture of mammalian suspensions. Incubators provide a suitable environment with carbon dioxide (CO2) supply and humidity control and ensure sufficient oxygen transfer and homogenization of cell suspension by appropriate…
Cell Therapies Roundtable: Building the Pillars to Success
In order to deliver cell-based therapies on a commercial scale, cell therapy companies and suppliers must form partnerships in order to overcome existing manufacturing, regulatory, and analytical challenges. Four leading cell therapy experts discuss what is and what has to be done in order to accomplish this objective.
Utilization of Allogeneic Liver Progenitor Cells Expanded from Adult Healthy Human Livers to Treat Genetic Disorders
Promethera Biosciences presents this case study detailing how HHALPC from normal adult livers can be purified, expanded In vitro and utilized to successfully treat patients with Crigler-Najjar disease.
Moving Cell Purification Methods from Bench to Bedside
The technological innovations and improvements to cell purification and other cellular analysis-based processes have dramatically increased sample throughput rates resulting in an improved ability to treat cancer, autoimmune diseases, and a range of applications in regenerative medicine.
Tackling the Challenges in the Manufacturing of Cell-Based Therapies
While cell-based therapies offer huge potential, significant challenges, including GMP manufacturing, scaling-out, and delivery must be addressed and overcome in order to justify and successfully autologous and allogeneic provides to the market.
From R&D to Commercialization: Challenges for Cell Therapy Manufacturing
In order for cell therapy companies to successfully evolve from R&D to commercialization, there are many lessons learned from the protein business that can be applied to the cell therapy market.
Implementation of a 2000L Single-Use Bioreactor and Clarification System at an Existing cGMP Facility
This case study highlights a seven month project to upgrade a 100L stainless steel facility to a 2000L single-use facility without affecting current clinical manufacturing while adhering to cGMP requirements.
Manufacturing Roundtable: Building Biomanufacturing Expertise in Emerging Markets
The mainstream adoption and success of mobile, single-use manufacturing platforms, combined with the introduction of off-site training programs provide companies with the ability to quickly set up and operate fully functioning biomanufacturing facilities globally.