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BioProcess Technology Consultants offers unique, actionable information resources for the biopharmaceutical industry. The insightful analysis in our reports is designed to help decision makers build and put to work comprehensive business and technical strategies for the complicated topics covered.
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The State of Mammalian Cell Culture Biomanufacturing
This report offers an in-depth review of the growth in sales and production demand for biopharmaceutical products currently on the market and in development. The report provides a comprehensive analysis of the current and future supply and demand for mammalian cell culture capacity, including the geographic distribution of manufacturing capacity, the impact of facility utilization rates on overall capacity requirements, and the influence of emerging technologies on manufacturing facility design and utilization.
Drawing from BPTC’s proprietary Biopharmaceutical Product database, this report highlights the continued growth of total biopharmaceutical sales in 2010 to $107 billion, or approximately 12% of the total pharmaceutical market. We review the production methods used for the top biopharmaceutical “blockbuster” products and analyze the impact of those produced in mammalian cell culture on global manufacturing capacity showing that despite the continued growth in sales of these products and the associated requirement for increasing mammalian cell culture capacity to meet this market demand, overall capacity utilization rates have remained low due to technological advances. Our analysis shows that industry-wide capacity utilization will increase approximately 50% from 2011 to 2016 as construction of new capacity slows and more products reach the market.
The impact of this increasing utilization rate on biomanufacturing capacity and the current concentration of this capacity in a small number of companies may limit some company’s ability to access capacity in a timely manner. While the five product companies controlling the majority of cell culture manufacturing capacity have more than enough capacity to accommodate their anticipated future needs and keep their own utilization rates low, many of the remaining companies, which either have smaller-scale manufacturing capacity or are relying on CMOs, may find a need for additional capacity by 2016 suggesting that CMOs and smaller biopharmaceutical companies may announce the installation of new capacity in the coming years.
This 150-page report provides an unrivaled analysis of the drivers of biomanufacturing supply and demand. With 38 figures and graphs and 27 tables, including a comprehensive list of sales data and bulk product requirements for all biopharmaceutical products produced in mammalian cell culture currently on the market, The State of Mammalian Cell Culture Biomanufacturing provides detailed, data-driven insight into the biomanufacturing market to inform senior executives and program managers with the essential and timely information needed to fully understand the mammalian cell culture biomanufacturing landscape and to stay competitive.
Available only by download, in PDF format.
The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medicinal Product Dossier (IMPD) or equivalent for first in human clinical trials. The primary focus of the report is on the technical, regulatory, and management issues related to process development, manufacturing, quality control, and analysis of fulllength single specificity monoclonal antibody products produced in mammalian cell culture. The report provides a detailed analysis of the technical and regulatory requirements necessary to successfully develop therapeutic monoclonal antibody products from discovery through first-in-man clinical trials and also gives an overview of the strategic and regulatory considerations for late-stage development and commercialization of these products, including a detailed discussion of such important issues as process validation, Quality by Design, manufacturing economics, and the risks and benefits associated with the use of platform processes.
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Good Manufacturing Practices Guide
This Guide analyzes the contents of the current versions of the Good Manufacturing Practice (CGMP) rules and guidances laid down by the US, the European Union (EU), Canada, and Japan, the guidelines published by the World Health Organization (WHO), and the International Conference on Harmonization (ICH). The chapters of this Guide dealing with compliance take their order of contents from the content pages of the US Code of Federal Regulations #21CFR210-211—the principal GMP rules, and 21CFR600, the general regulations for the production of biologicals. Each topic is covered in turn, with emphasis being placed on the most critical requirements. A set of forms suitable for self-inspections, using as a format the FDA’s "Six Systems" approach, are provided as an appendix. There are also recommendations for dealing with external inspections, at the planning, implementation and follow-up stages. There are sections dealing with the key factors of the inspection of all types of manufacturing facilities, including instructions for staff behavior and the handling of official citations and warning letters. In order to ensure the maximum utility of this Guide, numerous references to Web sites, publications and conferences specializing in GMP compliance and training are provided at the end.
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Good Laboratory Practices Guide
This Guide examines the GLP regulations of the United States and other countries in detail and provides guidelines for compliance, using as a basis the GLP requirements published in the US Code of Federal Regulations, Title 21, Part 58, 2008 Edition. These regulations are intended to assure the quality and integrity of any safety or efficacy data, especially animal testing data, submitted in support of an application to move into cliniReport covercal trials or for approval to market the new drug. Following this Guide’s recommendations, scientists and managers responsible for academic research, commercial start-up research and development operations, or established industrial laboratories can understand the impact of GLP requirements on their work and assist them in achieving full compliance simply and inexpensively. The recommendations presented in this Guide have been distilled from a large body of information and opinion. The most recent guidelines issued by the FDA and other regulatory authorities to industry and to inspection staff have been referenced. Opinion and advice collected from other regulatory consultants, including ex-FDA personnel, has been reviewed and taken into consideration. A set of forms derived directly from the 21CFR 58 regulations is provided as an appendix. They can be copied directly from the book as needed. Each requirement is covered to ensure that every compliance factor is reviewed.
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Good Clinical Practices Guide
The most time-consuming and expensive task in achieving approval to market a new drug, biological or medical device is to confirm the safety and efficacy of the product by testing it on human subjects. In order to ensure that the clinical trials or studies are performed in a scientific, humane and ethical manner, codes of Good Clinical Practice (GCP) have been drawn up by most countries and are now the subject of international agreement. A clinical study is initiated and monitored by the Sponsor, planned and performed by the Investigator and reviewed and approved by the Institutional Review Board (IRB). This Guide examines in detail the responsibilities and activities of these three main parties and gives practical advice to assist each to fulfill their obligations. To support the work of these three main participants in the clinical study process, numerous forms and check-lists have been prepared and some of them are incorporated into official Guidelines. The most relevant of these have been reproduced in this Guide and may be copied by readers for their own use. The Guide will assist these people to structure and monitor the study so as to ensure its acceptance by the regulatory agencies as being unbiased, accurate and humane.
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All 3 Guides: Good Manufacturing, Laboratory, and Clinical Practice Guides
Offered at a 15% discount from the individual prices.
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Price: $1,272.00Mammalian Cell Culture Supply and Demand Report
Published in 2009 and now available at a significant discount from the original selling price, this report provides an extensive analysis of the supply and demand for mammalian cell culture from 2008 to 2014, including an in-depth discussion and analysis of the key drivers and variables for this capacity.
Available only by download, in PDF format.