Overview of Best Practices for Biopharmaceutical Technology Transfers.

نویسندگان

  • Sushil Abraham
  • David Bain
  • John Bowers
  • Heidi Kenty
  • Victor Larivee
  • Francisco Leira
  • Jasmina Xie
  • Jonathan Tsang
چکیده

Technology transfer is a key foundational component in product commercialization. It is more than just the transfer of documents; it relates to all aspects of the transfer of knowledge and experience to the commercial manufacturing unit to ensure consistent, safe, and high-quality product. This is the first in a series of articles from the BioPhorum Operations Group (BPOG) member companies discussing best practices and benchmarking of biopharmaceutical technology transfer. In this article, we provide the common terminology developed by BPOG to accommodate both transferring and receiving organizations. We also review the key elements of a robust technology transfer business process, including critical milestones. Finally, we provide a brief overview of the articles in this series.

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

The NISTmAb Reference Material 8671 lifecycle management and quality plan

Comprehensive analysis of monoclonal antibody therapeutics involves an ever expanding cadre of technologies. Lifecycle-appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators in a pre-competitive space, an effort that may be facilitated by a widely available test metric. Biopharmaceutical quality materials, howe...

متن کامل

Data and Methods for the Production of National Population Estimates: An Overview and Analysis of Available Metadata

Thomas Spoorenberg Translated by: Elham Fathi Statistical Center of Iran Abstract. Official population estimates can be produced using a variety of data sources and methods. These range from the direct extraction of information from continuously updated population registers to procedures for updating the status of a population enumerated previously in a periodic census. Additional sources and ...

متن کامل

Biopharmaceutical Innovation System and the Influence of Policies: The Case of Taiwan (2000-2008)

This article discusses the influence of policies on the development of biopharmaceuticals. We choose the experiences of Taiwan for our empirical study and focus on the evolution between 2000 and 2008; in the period of time the country provides an interesting example for further exploration of biopharmaceutical policies. Among all the policies, the two National Programs (National Research Progra...

متن کامل

Recent advances in optimal cell banking of mammalian cells for biopharmaceutical production

2015 Mammalian cells are routinely used in the biopharmaceutical industry for production of recombinant therapeutic proteins. Cell banking to ensure preservation of these cells at low temperatures for an extended period of time is at the core of establishing a manufacturing process utilizing these cells and various strategies have evolved over time to ensure recovery of viable ‘and’ functional ...

متن کامل

Biopharmaceutical Innovation System in China: System Evolution and Policy Transitions (Pre-1990s-2010s)

Background: This article sets up the initial discussion of the evolution of biopharmaceutical innovation in China through the perspective of sectoral innovation system (SIS).Methods: Two data sources including archival documentary data and field interviews were used in this study. Archival documentary data was collected from China Food and Drug Administration (CFDA) and Chinese National Knowled...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

عنوان ژورنال:
  • PDA journal of pharmaceutical science and technology

دوره 69 5  شماره 

صفحات  -

تاریخ انتشار 2015