The manual preparation of cell banks in screw-capped cryovials is a slow and labour-intensive process which, due to the sensitivity of cells to the cryopreservation solutions, limits the sizes of batches that can be produced. Manual pipetting and vial-capping tasks increase contamination risks and quality control costs, and raise the likelihood of strain and repetitive motion injuries amongst laboratory staff. TAP Biosystems set an objective to create an automated system for reducing manual processing steps while increasing throughput, and maintaining the same or better sample quality over existing manual processes. Significant improvements have been achieved in tube processing times, reproducibility of filling volumes, and QC costs — all of which are described in this paper…
Tag: <span>biopharma</span>
Government policies affecting intellectual property rights and the review of food and health care products dramatically influence investments in research leading to the development and sale of products that serve unmet medical needs or provide consumers with safe sources of food and drug products at a low cost. When statutes that affect several regulatory agencies are revised within a short time period, institutions that rely on exclusive rights offered by those agencies in exchange for obligations of disclosure and compliance must alter their business plans to adjust to new rules leading to the benefit conferred by the government. In 2011, the Leahy-Smith America Invents Act (AIA) was passed, changing many aspects of the federal statutes relating to the United States Patent and Trademark Office (PTO), and in 2010, the Patient Protection and Affordable Care Act (PPACA) was passed, which included the Biologics Price Competition and Innovation Act (BPCIA), requiring the United States Food and Drug Administration (FDA) to establish an abbreviated regulatory approval pathway for complex macromolecules produced in living cells or organisms. This series of articles briefly reviews key aspects of the AIA and the BPCIA, plus recent court cases relating to complementary periods of exclusivity offered by the FDA and the PTO, which should be of great interest to academic and corporate institutions having an interest in the life sciences. Important aspects of the AIA will be discussed in the first article in this series…
Single-use systems (SUS) have been employed in biopharmaceutical manufacturing for over 15 years. Consistent year-to-year growth has been seen both in the total volume of sales and the number of manufacturing steps in which SUS are being used. It is projected that the majority of commercial-scale biologics manufacturing will be done in disposable equipment in the near future because of improvements in SUS design and innovation. These devices can significantly reduce capital costs (for example, stainless steel vessels), eliminate equipment cleaning and sterilization, improve turnaround times, and reduce concerns about microbial contamination within a production facility. As reported in this year’s 8th Annual Survey of Biopharmaceutical Manufacturing, however, the rate of growth in SUS use may be slowing. Contributing factors are: 1) the economy; and 2) the need for more consistent product standardization (e.g., design, quality, and leachables/extractables [L&E]) data that regulators and industry end-users can accept with confidence…
Single-use processing solutions spanning both upstream and downstream applications are being embraced by the biopharmaceutical industry. The advantages of the single-use approach to industrial cell culture versus traditional stainless steel and/or glass bioreactors has resulted in the recent commercialization of several single-use bioreactors at small (3–15L), intermediate (50–500L) and large scales (>1000L). Recent innovations are combining the features of conventional bioreactors with the ease-of-use benefits associated with single-use technology for the optimization of mammalian cell growth and recombinant protein expression. This article will provide a detailed characterization of the single-use Mobius® CellReady 3L Bioreactor capabilities as compared to a glass bioreactor, in terms of CHO cell growth, mixing, and volumetric mass transfer coefficients (kLa) for oxygen…
While global economies continue to struggle back from the recent recession, we are seeing clear evidence that budgets in most areas of biopharmaceutical manufacturing are returning to pre-crisis conditions. Because of the essential nature of pharmaceutical products and health services, healthcare sectors tend to be more recession resistant and return to growth sooner than other industries. In fact, respondents to our 8th Annual Report and Survey of Biopharmaceutical Manufacturing projected only increases for all budget areas this year. This is a change from last year where budgets continued to show decreases in areas ranging from outsourcing production, hiring new scientific staff, and new facility construction. As the financing crunch lightens, biomanufacturing facilities are reopening their wallets. However, anecdotally, vendors to the industry are indicating that buyers are continuing to be much more cautious with their spending. Sales cycles continue to be drawn out, and many end users are demanding more milestone performance and risk sharing from suppliers…