IBC’s 16th annual Bioassay Conference is the meeting for learning about developing, qualifying, validating, and maintaining important biological assays. Come and discover the newest techniques for streamlining development and validation using easy-to-understand statistical approaches. Hear how other assay developers are accelerating their development plans and meeting aggressive timelines. Learn about use of the newest technology and regulatory trends to develop the right assay, at the right time, in the quickest possible way. After attending this conference, you will catapult your…
Search Results for: antibody characterization
Products, Services, and Literature
Downstream Processing Product: SciPure 300 GMP production platform Applications: Tangential-flow filtration (TFF) Features: Revolutionary purification platform automates, documents, and analyzes any TFF application needed in a GMP environment. The user-friendly interface is built on the familiar Windows XP operating system and .NET framework; administrative users have easy access to and control over all process parameters, users, permissions, and recipes. The system logs all program variables and automatically maintains optimal TFF conditions through continuous data acquisition and precision control loops. Contact…
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…
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…
Proteomics Technology Applied to Upstream and Downstream Process Development of a Protein Vaccine
Development and manufacturing of recombinant-protein–based vaccines has in the past few years become very similar to that of other well-documented and well-characterized biological drugs. For investigational vaccines, chemistry, manufacturing, and controls (CMC) information is critical for a successful regulatory filing. The process development and CGMP manufacturing of a recombinant protein drug is on the critical path toward clinical phase 1 dosing and safety studies as well as proof-of-concept clinical studies (1, 2). However, resources invested in this process may be…
Integrated Strategies for Clone and Media Formulation Selection
Clone selection techniques used for development of stable, high-expressing recombinant cell lines suitable for robust fed-batch cell culture processes are critical for biopharmaceutical manufacturing. Basal media screening, feed development and addition strategies, and fed-batch bioreactor performance are all intimately tied to overall performance of the clones during scale-up. Serious issues can arise if a high-quality clone is not established, such as low or unstable protein yield and ineffective use of costly resources. PRODUCT FOCUS: Recombinant proteinsPROCESS FOCUS: ProductionWHO SHOULD READ:…