2009

Biopharmaceutical Information Infrastructure 2.0

Availability of the right information to the right people at right time is critical for understanding and improving existing processes within an organization. For a data-intensive industry such as biopharmaceuticals development and manufacturing, access to data and information enables companies to understand and streamline their operating and business processes. But most organizations fail to leverage such information for better decisions because they mismanage it. Some try to fill the gap between information and end users by introducing various applications and…

Banking Parental Cells According to CGMP Guidelines

It is often difficult to accurately anticipate quality standards across today’s global regulatory environments. In recent years, quality expectations have increased as a result of public demand and government regulation while regulatory requirements are often written with limited specificity. Regulations pertaining to parental cell lines (cells engineered to become biotherapeutic production cell lines) is one such area where current regulations leave room for interpretation. Here we explore some important considerations for determining quality standards for parental cell lines. Cell Line…

Accelerating Bioassay Transfer in a GMP Environment

Most products in discovery by pharmaceutical companies today are biopharmaceuticals. Made by living organisms, these are typically large–molecular-weight products that rely on their secondary and tertiary structure for therapeutic effectiveness. Synthetic small molecules and biopharmaceuticals both require analytical verification for release, but only biopharmaceuticals require functional potency assays for investigational new drug (IND), biological license application (BLA), and new drug application (NDA) submissions. Those activities often require elaborate transfers of diverse, biological, product specific assays that carry greater chances of…

Efficient Development of Stable High-Titer Cell Lines for Biopharmaceutical Manufacturing

Commercial manufacturing of therapeutic monoclonal antibodies (MAbs) commonly uses mammalian cells to generate large quantities of a drug. Identifying cell lines that stably produce high protein titers is, therefore, a critical part of biopharmaceutical development. Unfortunately, identifying suitable cell lines is traditionally a time-consuming, labor-intensive process. That’s because their productivity and stability can vary enormously, so large numbers of clones must be screened to find those with both the highest yield and a desired level of product quality (1). Cell-line…

Using In Vitro Assays for Therapeutic Enzyme Characterization

A number of biopharmaceuticals are enzymes that act in vivo on high-molecular substrates. It can be a challenge to develop in vitro methods for accurately assessing their biological activity. Interest is also developing in using enzyme kinetic parameters as product quality attributes under the quality-by-design (QbD) initiative. Among biotechnology therapeutics, the conventional method of expressing potency is in units/mg of biopolymer. For enzymes, a unit of activity was defined in 1958 by the International Union of Biochemistry and Molecular Biology…

Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 2

Some of the numerous feeding strategies are more appropriate than others for certain types of cell culture production systems. Once a nutrient supplement has been identified as described in Part 1 of this three-part review (1), a supplementation strategy must be chosen. Supplementing at too great a rate may expose log-phase cells to stresses such as increased osmolality and lactate levels that would inhibit biomass expansion. But inadequate supplementation can lead to early apoptosis through rapid depletion of selected important…

A Risk-Based Aproach to Establishing Animal-Component–Free Facilities

Bovine spongiform encephalopathy (BSE) and its potential to affect humans emerged as a concern in the 1990s. So suppliers of many essential animal-sourced components used in cell culture and fermentation processes became concerned about the potential for material contamination with prions. Viruses also can be present in raw materials derived from animal origins. Many important drug and vaccine products are made by mammalian cell culture or bacterial fermentation, so their biological safety is paramount. However, it is very difficult to…

Ireland for Science, Technology, and Innovation

Ireland is an exciting place when it comes to research, development, innovation, and commercialization in biologics and life sciences. The government of Ireland’s strategy for Science Technology and Innovation (ST&I 2006–2013) includes key deliverables stressing the importance of a dynamic infrastructure to enable further growth in these important fields. A strong foreign direct investment policy has secured >US$5 billion from global players including Genzyme, Centocor, Merck, Wyeth, and Pfizer in recent years. Ireland also has built a strong indigenous biotech…

Fifth Annual Biopharmaceutical Manufacturing and Development Summit

According to a recent industry survey published in Pharmaceutical Manufacturing, the top three goals of most biopharmaceutical manufacturing companies are to improve in these areas: manufacturing agility, capacity use, and internal quality management. Close on the heels of those top three are improved alignment of internal goals with those of business partners, improved on-time delivery, and reduced inventory. The BMD Summit is the best forum to gain the data and consultation you need to enable you and your interdisciplinary team…

Global Marketplace

Disposable Component ID Product: Single-use tubing and molding components Applications: Biopharmaceutical manufacturing Features: The industry wants reliable identification of components in single-use products. AdvantaPure addresses that with identification solutions that include the AdvantaLabel molded silicone labeling system, PET process-equipment tracking, and GammaTag gamma-irradiation–sterilizable RFID tags. The new DocuLink identification product (patent pending) will soon be launched to provide users a way to reference batch, lot, and validation documentation after installation of a molded-silicone manifold. Contact AdvantaPure www.advantapure.com Hydrophobic Interaction Product:…