The Leahy-Smith America Invents Act (AIA) and the Biologics Price Competition and Innovation Act (BPCIA) are dramatically reshaping business strategies designed to protect intellectual property and regulatory exclusivity rights granted by the United States Patent and Trademark Office (PTO) and the Federal Drug Administration (FDA) to the sponsors of new and follow-on versions of many biopharmaceutical products. The AIA alters many provisions in the U.S. patent statutes, most notably long-standing policies and practices relating to the conditions for patentability of an invention, particularly 35 USC §§ 102 and 103 relating to novelty and non-obviousness, respectively, and introduces new provisions relating to post-grant review proceedings and prioritized examination that will affect the business plans of academic and corporate institutions seeking to discover and develop health care products that serve unmet medical needs or provide consumers with safe sources of drug products at a low cost. The BPCIA implements many new provisions relating to the abbreviated review and approval of follow-on biopharmaceutical products. Important aspects of the BPCIA, particularly issues identified in draft guidance documents that were released by the FDA in February 2012 concerning the characterization, comparison, and evaluation of reference and follow-on macromolecules, will be discussed in this article. Political issues that may jeopardize the BPCIA, economic considerations faced by drug product sponsors, and public reaction to the guidance documents are also discussed in this final article of a three-part series describing key provisions of the AIA and the BPCIA that affect intellectual property and regulatory exclusivity rights of institutions having an interest in developing novel or follow-on versions of biopharmaceutical drug products…
Tag: <span>biopharmaceuticals</span>
Tissue culture growth medium derives a substantial fraction of its growth-stimulating activity from the fetal bovine serum (FBS) commonly used as a supplement. In addition to the source of serum, non-essential additives such as colorized pH indicator dyes may also affect the growth stimulating properties of complete media. We show here that both of these culture medium components can dramatically affect gene expression in vitro. Using a custom gene expression chip for herpes simplex virus 1, we demonstrated significant changes of expression levels in several categories of viral genes including the immediate early viral transcription factors ICP0 (p < 0.05), ICP4 and ICP27 (both p < 0.001). This dependence of virus growth on serum source and other medium components have implications for not only in vitro virus studies, but also viral vector design and vaccine efficacy. This is especially true when examining a large DNA pathogen that potentially contains response elements that are common in the mammalian genome...
The Patient Protection and Affordable Care Act (PPACA), which was passed in 2010, included the Biologics Price Competition and Innovation Act (BPCIA) authorizing the United States Food and Drug Administration (FDA) to establish an abbreviated regulatory approval pathway for complex macromolecules produced in living cells or organisms. The BPCIA implements many new provisions relating to the abbreviated review and approval of follow-on biopharmaceutical products. These include: (1) evaluating the biochemical properties of reference and follow-on macromolecules; (2) establishing procedures for the exchange of information between product sponsors, regulatory agencies, and the federal court system; and (3) establishing periods of regulatory exclusivity which complement patent rights typically awarded to the sponsor of a reference molecule. Important aspects of the BPCIA, particularly issues relating to the exchange of information between product sponsors and the establishment of periods of regulatory exclusivity protecting a novel or follow-on macromolecule are discussed in this article. This is the second in a series of three articles describing key provisions of the Leahy-Smith America Invents Act (AIA) and the BPCIA that affect intellectual property rights of academic and corporate institutions having an interest in the life sciences…
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…
Contract testing organizations (CTOs) offer considerable value by providing testing services and expertise that may not be available within organizations that are developing and producing biopharmaceuticals, from virtual companies to fully integrated international organizations. CTOs are constantly challenged by the breadth of services that are requested as well as the levels of regulatory compliance that are expected and the degree of oversight that various companies intend to impose. And knowing this variability of needs and expectations often results in a CTO trying to become “all things to all people” regarding assay tech transfer, validation, and qualification. For example, with the same type of sample from the same stage of product development, one company may expect its contracted testing to comply with 21 CFR Part 210 and 211 (good manufacturing practice [GMP]) while another may expect its testing to comply with 21 CFR Part 58 (good laboratory practice [GLP]) with different assay validation expectations for each approach…
Biosimilars, and related biopharmaceutical biobetters and biogenerics, are still relatively new, but are already starting to impact worldwide biopharmaceutical markets. Most discussions of biosimilars center on developed regions where markets are mature and manufacturing capabilities allow for the cost-efficient manufacture of these complex molecules. This article covers the development of these products outside the United States (US), European Union (EU), and other developed, generally rather affluent and high-technology economy-based countries. To start, we first offer some definitions…
The expansion of stem cells, including mesenchymal stem cells (MSCs), has been successfully demonstrated using microcarrier-based small bioreactors such as spinner flasks. In this study, we explored a simple alternative for microcarrier-based MSC expansion using conventional shake flasks. This method relies on a new type of shaker with built-in CO2 gas control capability, the New Brunswick™ S41i incubator shaker. The expansion of adipose-derived mesenchymal stem cells (AdMSCs) was compared between shake and spinner flasks containing microcarriers. The AdMSCs were seeded at a density of 3 × 103 cells/cm2 in both setups, each containing 0.5 g of plastic microcarriers and 50 mL of stem cell growth medium. The cell culture experiments were conducted over 12 days with samples collected daily for cell growth, biochemistry, and metabolite analysis. The study revealed that AdMSCs cultured under shake flask conditions achieved excellent growth under 12-day batch-culture conditions. Finally, the AdMSCs expanded using the shake flask method retained high quality stem cell characteristics, as indicated by CD44 and CD90 stem cell marker assays, and the ability of these cells to differentiate into either adipocytes or osteocytes…
In today’s volatile sera market, it is critical that sera users worldwide thoroughly review their supply relationships and update sourcing and risk mitigation strategies. BioProcessing Journal’s recent article by Siegel and Foster highlighted the impact of selecting the appropriate country of origin as one criterion for purchasing decisions. Many more vital selection criteria exist to ensure a sera supplier provides long-term assurance of supply and integrity of supply. This article identifies critical questions sera users should ask their suppliers and explains why they should ask them…