| Providing Sterility Assurance Between Stainless Steel And Single-Use Systems |
As biopharmaceutical
manufacturers experience the
benefits of single-use systems,
many want to expand their
use in both upstream and downstream
applications. This isn’t surprising,
considering that the increased volume
and diversity of biopharmaceutical
products are causing manufacturers to
design their facilities based on shorter
production runs with multiple
changeovers. Meeting such demands
requires operational flexibility. By John Boehm and Brent Bushnell |
12/03/2008 |
313.0 KB |
| Evolving Toward Single-Use Bioprocessing - From Solutions To Holistic Value Creation |
As the biopharmaceutical industry continues to evolve
and mature, the challenges facing it change as well.
Among many other pressures, bioprocessors are
increasingly pressured to shorten drug development timelines,
reduce costs, diversify product pipelines, and implement riskbased
strategies, not to mention maintaining continued focus on
patient safety and regulatory compliance. By BioProcess International
|
12/03/2008 |
136.0 KB |
| Article: Successful Transfer And 200-Fold Scale-Up Of A r-CHO Cell Fed-Batch Process Using A New cGMP Compliant Basal And Feed Medium Combination |
A research process developed in shake flasks and 0.6L bioreactors was transferred from an independent development laboratory and rapidly scaled up to a 100L production bioreactor. A newly developed, commercially available, chemically defined basal and feed medium combination designed specifically for cGMP fed-batch production was a key element in this success. |
12/02/2008 |
278.8 KB |
| Case Study: Rapid 200 Fold Scale-Up Of A Fed-Batch Bioreactor Process For A CHO Cell Line Expressing A Mab |
A fed-batch bioreactor process for a CHO cell line was transferred from a client and scaled 200 fold with minimal process development evaluation and testing. |
12/02/2008 |
39.5 KB |
| Case Study: Development Of A Drop-In Purification Step For Removal Of Aggregates From An Antibody Therapeutic |
Reduced aggregate level in large scale manufacturing downstream process from very high to undetectable levels. |
12/02/2008 |
38.7 KB |
| Video: Bio-Rad Process Chromatography Skid |
The versatile Bio-Rad process chromatography skid can be customized for different applications using a core platform and integrating optional hardware. |
12/02/2008 |
4.36 MB |
| Video: Bio-Rad Media Transfer Device |
The Bio-Rad media transfer device is a self-contained movable unit designed to transfer chromatography media between a tank and the column and to deliver cleaning solutions to Bio-Rad InPlace columns for sanitization. |
12/02/2008 |
3.53 MB |
| Video: Bio-Rad MainFrame Lifting Accessory |
The Bio-Rad MainFrame lifting accessory enables hoist-free operation of chromatography columns. |
12/02/2008 |
2.17 MB |
| Video: Bio-Rad EasyPack Column |
Bio-Rad EasyPack columns offer a traditional approach to process columns for biopharmaceutical applications. |
12/02/2008 |
3.43 MB |
| Product Brochure: Global Regulatory Services |
Catalent's regulatory and clinical experts have a wide range of in-depth experience with both established and novel pharmaceutical dosage forms across a wide range of therapeutic areas. The global regulatory services group has an extensive consulting portfolio. |
11/26/2008 |
321.0 KB |
| Feature Article: Parenteral Packaging Concerns For Biotech Drugs: Compatibility Is Key |
Biotechnology promises treatments and even cures for many diseases previously
considered intractable. Although the biotech industry began just about a quarter-century ago, since the late 1990s the number of new biopharmaceutical approvals has nearly equaled those for new small-molecule drugs. By Frances L. DeGrazio |
11/25/2008 |
188.8 KB |
| Feature Article: If You Didn't Write It Down, It Didn't Happen |
We all want to make sure that the drugs that we buy and use to treat and cure illness are safe. Because of the complexity of human biology, there can
be no 100% guaranty that a drug will work without causing some other problem (e.g., dizziness, nausea, or sleeplessness). To ensure that the public and patients’ interests are considered to the highest degree, we rely on regulatory
agencies to enforce rules governning everything going into the development
and manufacture of a drug. By Leah J. Rosin |
11/25/2008 |
212.0 KB |
| Feature Article: Chlorine Dioxide, Part 2 |
CD has been demonstrated effective
in both the aqueous and gas phases,
which is highly advantageous for
biopharmaceutical applications. It is easy
to change CD from one state to the
other. One benefit of the membrane
sachet technology (see below) is that it
can be used to generate an aqueous
solution that can be stored until needed. By Barry Wintner, Anthony Contino, and Gary O'Neill, BioProcess International
|
11/21/2008 |
197.8 KB |
| Feature Article: Addressing Product Improvement Using Chemical Modification In Biopharmaceutical Manufacture |
Any modification of a natural
protein (by either chemical means or
site-directed mutagenesis) for use as a
biotherapeutic immediately raises the
issue of immunogenicity and, to a
lesser extent, stability. Indeed,
development of antibodies against
therapeutics is receiving increased
study. Immune reactions secondary to
administration of protein therapeutics
is not a new problem and was a major
issue with animal-derived insulin
products. By Roger L. Lundblad and Ralph A. Bradshaw, BioProcess International |
11/21/2008 |
256.8 KB |
| Technical Bulletin: LONG®R3IGF-I Storage, Stability and Specifications |
LONG®R3IGF-I is available as a lyophilized powder, Catalog No. 85580C, or a 1 mg/mL liquid formulation in 100 mM acetic acid, Catalog No. 91590C. Both formats are shipped at ambient temperature and stored at 2 to 8 C. |
11/20/2008 |
61.9 KB |
| Technical Bulletin: LONG®R3IGF-I Frequently Asked Questions – Strategic Sourcing |
LONG®R3IGF-I is a dedicated raw material manufactured exclusively for cell culture applications providing a consistent, compliant and reliable alternative to recombinant insulin. It is not subject to market fluctuations and shortages as is recombinant insulin. |
11/20/2008 |
57.8 KB |
| Technical Bulletin: LONG®R3IGF-I Frequently Asked Questions |
LONG®R3IGF-I is a dedicated raw material manufactured exclusively for cell culture applications providing a consistent, compliant and reliable alternative to recombinant insulin. It is not subject to market fluctuations and shortages as is recombinant insulin. |
11/20/2008 |
78.0 KB |
| Datasheet: LONG®R3IGF-I Liquid |
LONG®R3IGF-I is a recombinant analog of human insulin-like growth factor-I (IGF-I) that has been specifically engineered for the enhancement of cell culture performance. |
11/20/2008 |
42.4 KB |
| Brochure: LONG®R3IGF-I: Your Insulin Alternative |
LONG®R3IGF-I is a dedicated raw material manufactured exclusively for cell culture applications providing a consistent, compliant and reliable alternative to recombinant insulin. It is not subject to market fluctuations and shortages as is recombinant insulin. |
11/20/2008 |
1.25 MB |
| Technical Bulletin: The Science of LONG®R3IGF-I: Features and Benefits |
LONG®R3IGF-I is a recombinant growth factor analog of human
insulin-like growth factor I (IGF-I). It is specifically designed and manufactured for mammalian cell culture and is intended to support large-scale manufacturing of biopharmaceuticals. |
11/20/2008 |
144.6 KB |
| Video: CHT Packaging Guidelines |
Bio-Rad offers optimized protocols and hardware for packing and unpacking CHT in process columns. The guidelines for handling and packing are recommended for all CHT users to ensure reproducible, high-quality results and to extend the life of the CHT media. |
11/19/2008 |
4.77 MB |
| Video: Packing CHT In The Bio-Rad Inplace Column |
Ceramic hydroxyapatite or CHT is a versatile chromatography support used for the separation of biological molecules including polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins. |
11/18/2008 |
7.99 MB |
| 2009 Pittcon Conferee Brochure |
It's the scientific event of the year, and from March 8–March 13, 2009, more than 20,000 attendees will gather at Pittcon in Chicago, Illinois USA to see what's new, exchange ideas, and learn. Pittcon is a unique experience where you can advance your own scientific interests and gather technical information that will help you back in the lab. Take a moment and see all
of the possibilities. |
11/18/2008 |
359.1 KB |
| Video: Bio-Rad InPlace Column |
Bio-Rad InPlace process-scale chromatography columns are designed for industrial applications with contained filling, packing, unpacking, and cleaning for safe and hygienic column operation. |
11/18/2008 |
4.21 MB |
| Video: Bio-Rad Introduction |
Bio-Rad is a leading provider of chromatography equipment and media for the bioprocessing industry. Our customers have access to our expert teams of engineers, scientists, and quality assurance specialists who control the steps of all design and manufacturing processes. |
11/18/2008 |
3.70 MB |
