The biopharmaceutical market accounts for about 20% of the total market for pharmaceuticals, but its share continues to increase because of double-digit compound annual growth rates leading to projections that by 2014 eight of the top 10 best-selling drugs will be biologics (1). The industry faces many challenges and opportunities, as Jim Davies of Lonza Biologics explained to me: “Biomanufacturers have to contend with what is at present a dynamic technical and commercial landscape. Industry consolidation continues to occur as…
Manufacturing
NIR Spectroscopy Analysis of Phosphate Salts
Confirmation of raw material quality is a vital part of biopharmaceutical manufacturing processing. Incorrect or poor-quality vendor materials account for a considerable portion of failed and recalled product. To prevent these expensive problems, strict quality control (QC) procedures are often implemented and used to screen for inappropriate incoming materials. QC procedures commonly used are chemical tests that involve removing samples to a laboratory and performing, which can at times be complex, time-consuming, and laborious protocols. A common test procedure that…
Development of an In-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 2
During biopharmaceutical manufacturing, final drug products can get contaminated with host-cell proteins (HCPs) derived from a production cell line. HCPs can elicit adverse immune responses, so regulatory authorities require accurate monitoring of their presence and concentration in final drug products. Because they are robust and offer good throughput, enzyme-linked immunosorbent assays (ELISAs) are the first choice for HCP detection to monitor product quality. Generic ELISA kits are commercially available for HCP detection with a number of commonly used…
Optimizing Cryopreservation for Therapeutic Cells
Biopreservation suppresses degradation and enables postpreservation recovery of structure, viability, and function. Although there are several biopreservation techniques (indicated in “Biopreservation Methods†box), most laboratories use either standard cryopreservation protocols (the far majority) or vitrification (much more limited in broad systems application) when freezing cells for research and clinical applications. Isopropanol freezing containers such as the Mr. Frosty device from Nalgene Labware have made cryopreservation easier in many applications, and controlled-rate freezers allow users to program and manipulate…
Where Will Technology Take Cell Therapy?
The cell therapy industry’s biggest challenge is in manufacturing. Technologies are needed to support expansion of large numbers of cells for commercial production. A number of sources are presenting options: e.g., standard two-dimensional tissue cultures that “grow up†to Corning HYPERFlask and CellSTACK or Nunc Cell Factory systems; hollow-fiber–based equipment; and disposable bags and traditional stirred-tank bioreactors. Each has its place and application, but how can companies choose among them? Where and when do they initiate scale-up process…
Intellectual Property Protection in the Digital Age
For most biotechnology and biopharmaceutical organizations, “business as usual†means a perpetual race to the finish line: Conceive a new invention, reduce it to practice, attain patent protection, repeat ad infinitum. But sometimes, the very technologies scientists use to expedite that chain of events (e.g., electronic laboratory notebooks and cloud-based laboratory data sharing) create security and authenticity holes. In essence, the more agile and sophisticated our work flow systems become, the more difficult it becomes to guarantee the…
Development of an In-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 1
After production and purification of biopharmaceuticals generated by cell culture expression systems, endogenous cell line proteins — commonly referred to as host-cell proteins (HCPs) — sometimes contaminate finished products. HCPs can elicit an immune response following administration of those drugs to patients (1), and cause potentially deleterious side effects. It is therefore imperative to minimize HCP contamination in finished biologics. Regulatory health authorities require monitoring of HCP contamination. They expect validation of each purification process to demonstrate its…
Building a Bridge to Commercial Success
The history of the biopharmaceutical industry is one of continual invention and reinvention, of business models that have adapted to weather uncertain product futures and shifting economic fortunes. Some of us followed the up-and-down (and often financially painful) progress of monoclonal antibodies toward their eventual commercial success — a wealth of experience to draw from as other classes of products make their way from laboratories and onto the market. The vast majority of regenerative medicines are still produced at laboratory…
Therapies of Tomorrow Require More Than Factories from the Past
Live cells are being incorporated as active agents and delivery vehicles for a broad range of emerging therapeutic strategies. Successful commercialization of a cell therapy requires more than proving its safety and efficacy to regulators. Ultimately a therapy must be commercially viable, allowing enough patients to be treated with an adequate financial margin to justify investment in it as a product. “Whether the cells used are universal (allogeneic) or patient-specific (autologous), it is unlikely to be wholly one or the…
Successful Commercialization Through Industry Collaboration
Nearly a year ago, the International Society for Cell Therapies (ISCT) decided to integrate industry into its organization to build a stronger platform for commercializing therapies. Robert Deans, vice president of regenerative medicine at Athersys, was invited to serve as a leader of ISCT’s Industry Task Force, which aimed to identify industry roles in its organization. Within two months, the task force invited industry members and chartered a white paper (1) that described how ISCT should go forward.…