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…
2008
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…
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…
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…
Will Diagnostics Return to Its Roots?
Diagnostic tests originated at patients’ bedsides more than 3,000 years ago. However, over the past 200 years, diagnostics moved into laboratories as the tests became more complex. Now further technological advances are bringing these tests out of the laboratory and back to a near-patient environment. This change in procedure will save both lives and money. Know Faster, Act Faster Use of diagnostic tests principally falls into three categories. The first is long-term monitoring of chronic diseases (e.g., measuring glucose levels…
Products, Services, and Literature
Validation Service: Confidence leachables and extractables testing Applications: Single-use equipment validation Features: Proprietary analytical techniques have been developed to detect low levels of extractables (including high-performance liquid chromatography, liquid and gas chromatography with mass spectrometry, and Fourier-transform infrared spectroscopy; testing is conducted with each test component in contact with the actual pharmaceutical formulation; other tests offered include bacterial challenge and viability testing, integrity test values analysis, and chemical compatibility testing Contact Sartorius Stedim Biotech www.sartorius-stedim.com Fermentation Product: BioFlo Pro fermentors…