February 2008

Products, Services, and Literature

Filtration Pumping Product: 620RE filtration pump Applications: Dead-end filtration and tangential flow filtration (TFF) Features: Gentler on the product in terms of shear stress when producing higher yields; provides unrivaled performance with a control ratio of 2650:1; requires minimal maintenance with no valves or seals to clog, resulting in reduced downtime; offers exclusive innovative PIN-secure protection feature that provides two levels of PIN protection; speed range can be capped to prevent accidental damage to delicate filters; keypad functionality can be…

TIDES 2008Oligonucleotide and Peptide Technology and Product Development

In 2007, TIDES attracted a record number of attendees and exhibitors. More than 700 conference delegates participated — and even more are expected to attend in 2008. TIDES is the only forum that covers manufacturing, formulation, delivery, process and analytical development, and overall market trends for peptide- and oligonucleotide-based therapeutics and diagnostics. A Billion-Dollar Industry Over the past two years nearly $3 billion worth of deals were made in the siRNA space. In addition, eight of the top 12 pharmaceutical…

Carbohydrates and Their Analysis, Part One

A mammalian cell exists, interacts, reproduces, and dies as a result of intricate biochemical and biophysical mechanisms — many of which remain unknown or not fully understood even today. Technological advances have allowed us to investigate the details of organelles and cell membranes, of the types of molecules synthesized within cells, and their distribution and trafficking and the effects they have in their environment. Among the main macromolecules that make up a living cell, DNA and protein structures were studied…

Variables Affecting Titer and Long-Term Stability of Virus Stocks

Assurance that monoclonal antibody (MAb) therapeutics produced using large-scale animal cell culture are free of adventitious agents is based on three complementary approaches. First, a master cell bank is extensively characterized to demonstrate its freedom from adventitious agents. In addition, end-of-production cell culture material is tested and demonstrated to be free of adventitious contaminants. Finally, the viral clearance capacity of a purification process is assessed using model viruses. PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS FOCUS: PURIFICATIONWHO SHOULD READ: MANUFACTURING, PROCESS DEVELOPMENT, REGULATORY…

Demonstrating Comparability for Well-Characterized Biotechnology Products

Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios. Development of flexible, comprehensive approaches in strategy development addressed evaluation of critical product characteristics, appropriate process steps to test, numbers of lots and levels of testing required, and assessment of product comparability (e.g., trending…

Accelerating Commercialization

In summer 2007 the MaRS (Medical and Related Sciences) center in downtown Toronto broke ground for a massive expansion. The fact that this innovative science and technology commercialization facility is more than doubling in size — to 1.6 million ft2 — less than two years after its official opening, indicates the healthy state of life sciences in Ontario. MaRS is a state-of-the-art convergence center where leading venture capitalists, pharmaceutical companies, research funding agencies, and cutting-edge businesses come together under one…

Construction and Start-Up Costs for Biomanufacturing Plants

All bioproducts heading to commercialization go through a rigorous process that includes research and development, proof of concept, and validation studies. Furthermore, the fabrication process of a biological product is very different from that of a classical (synthetic small-molecule) pharmaceutical. That’s not only because of specific characteristics and requirements of the molecular entities involved, but also environmental considerations and specific issues related to human health and safety. Such differences are reflected in the cost drivers of approved manufacturing plants. Herein…

Is the FDA Trailing on the Biopharmaceutical Drive?

In the heady days of the biotech boom of the early 1990s, the ground shook as salvo after salvo of innovative regulatory guidance documents emerged from the US Food and Drug Administration (FDA). Even their titles were innovative: “Points to Consider in the Production…” rather than the stodgy “Code of Federal Regulations, Volume X, Part XX.” The FDA was supporting the development of the emerging biopharmaceutical industry through rapid uptake of technological and clinical developments and speedy conversion into guidance…

Integrity Testing Low-Area Filters Using Air–Water Diffusion and an Automatic Integrity Tester

Both FDA and EMEA guidelines require integrity testing of filters used in processing sterile solutions such as large- and small-volume parenterals (LVPs and SVPs). The same regulatory agencies also require that corresponding test documentation be included with batch product records. PRODUCT FOCUS: PARENTERALSPROCESS FOCUS: DOWNSTREAM PROCESSING, SCALE-UPWHO SHOULD READ: QA/QC, PROCESS ENGINEERS, AND ANALYTICAL PERSONNELKEYWORDS: FILTRATION, INTEGRITY TESTING, VALIDATION, AUTOMATIONLEVEL: BASIC The function of integrity testing is to determine whether a particular filter is within or outside the validated specifications…