Recently added articles from Biopharm International:
Taking on 2009
Jan 01, 2009; ... The new year is a natural time to think about the future. In the current economic crisis, however, pondering the year ahead is unnerving, as it brings unsettling questions to mind. How bad, how broad, and how long will this recession be? And after the crash of the financial and auto sectors, ...
Vaccine Report
Jan 01, 2009; ... Russia Chooses Sanofi Pasteur Polio Vaccine for National "Project Health" Russia has chosen the inactivated polio vaccine (IPVl IMOVAX from Sanofi Pasteur (Paris, France), the vaccines division of Sanofi-Aventis, for primary immunization of all infants. The IPV doses are provided by the ...
FDA Releases Guidance Detailing Cooperative Manufacturing Agreements
Jan 01, 2009; ... The FDA has released a revised guidance document on acceptable terms for cooperative manufacturing arrangements for short supply, divided manufacturing, and shared and contract manufacturing for licensed biologies. The guidance is intended to ensure that the safety, purity, and potency of ...
Daschle Chosen to Spearhead Health Reform
Jan 01, 2009; ... Former Senate majority leader Tom Daschle has been chosen to become the new secretary of the Department of Health and Human Services (HHS). Daschle has been a close advisor to president-elect Barack Obama, and his long experience on Capitol Hill makes him a prime choice to steer health ...
MorphoSys and Galapagos to Co-develop Antibodies for Bone and Joint Disease
Jan 01, 2009; ... MorphoSys AG (Munich, Germany) and Galapagos NV (Mechelen, Belgium) have launched a long-term codevelopment alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis, and ...
AstraZeneca and Recipharm Partner for Biomanufacturing Facility
Jan 01, 2009; ... AstraZeneca has announced the divestment of the AstraZeneca Biotech Laboratory (ABL) in Södertälje, Sweden, to Recipharm AB of Sweden. Under the terms of the agreement, Recipharm Biotech AB (a new subsidiary of Recipharm) will lease the ABL from AstraZeneca for an initial period of 12 years ....
Revitalization, Reform Ahead for The FDA
Jan 01, 2009; ... New leadership and more resources aim to restore public confidence in the regulatory agency The US Food and Drug Administration has struggled with a depleted work force, obsolete information technology, and a weak science base, according to its advisory Science Board. A new ...
Facilitating Technology Transfer to Your CMO
Jan 01, 2009; ... The steps a biopharmaceutical manufacturer should take to ensure smooth technology transfers The following is a transcript of a podcast interview recorded at the 2008 BIO International Convention held in San Diego. BioPharm: What are the biggest challenges in a technology ...
Serving Two Masters: Reconciling EMEA/GAMP 5 and FDA/cGMP Phase 1
Jan 01, 2009; ... Quality by Design can help satisfy both the results-focused outlook of the EMEA and the process-focused outlook of the FDA Reconciling the requirements of the US Food and Drug Administration and the European Medicines Agency (EMEA) can be a headache for large, well-established biotech ...
Small-Cap Biotech Companies Conserve Cash to Ride Out the Prevailing Economic Conditions
Jan 01, 2009; ... The negative capital markets are forcing small- and medium-sized biotechnology companies to restructure, merge, or cut workforce A rally in the capital markets in the two days either side of the Thanksgiving holiday helped improve the fortunes of a number of industrial sectors, including ...
Buckle-Up, Biopharma
Jan 01, 2009; ... BioPharm International's third annual salary survey finds out if the turbulent economic climate is taking its toll on the biopharmaceutical sector. It is a time of change, not only for the finance and automobile markets, but also for the pharmaceutical and biopharmaceutical industries ....
Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes Part 2
Jan 01, 2009; ... ABSTRACT A key challenge in successfully implementing Quality by Design (QbD) is achieving a thorough understanding of the product and the process. This knowledge base must include understanding the variability in raw materials, the relationship between the process and the critical ...
Protein Peptide Purification using the Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) Process
Jan 01, 2009; ... ABSTRACT Increasing upstream yields have led to the need for downstream purification capacities. In this article, a new chromatographic process for the purification of biomolecules is presented. Its working principle is explained and possible areas of application in monoclonal antibody ...
Integrating Risk Management as an Effective Approach to Root Cause Analysis
Jan 01, 2009; ... By exploring root causes, companies can gain a clearer understanding of why problems occur. The issuance of the FDA's guidance in 2004 advocating a risk-based approach to current good manufacturing practices (cGMPs) has changed the basic paradigm for quality in the biopharmaceutical ...
New Technology Showcase
Jan 01, 2009; ... SILICONE MOLDING High purity tubing and hose manufacturer AdvantaPure recently tripled the size of its cleanroom facility to allow for increased production of molded silicone components. The new space houses several liquid injection molding stations used in the production of silicone ...
Spotlight on Disposables
Jan 01, 2009; ... Quick Disconnect Couplings Biopharmaceutical process engineers seeking secure and cost-effective aseptic equipment disconnects can now use the HFC39 Series couplings from Colder Products Company. Extensively tested for biocompatibility and performance, the HFC39 Series couplings are ...
Standardized, Hands-on Biomanufacturing Training is Essential
Jan 01, 2009; ... Skilled professionals are becoming more and more important as Big Pharma tries to reduce costs Several years ago, after conducting yet another disappointing job interview, I realized that the only way I was going to find competent manufacturing professionals was to steal them from the ...
An Alternative to the Scale-up and Distribution of Pandemic Influenza Vaccine
Jan 01, 2009; ... With baculovirus-based production in disposable equipment, vaccine can be available 10 to 12 weeks after an outbreak. Abstract An influenza pandemic is a global health risk and many solutions are being developed to attempt to address this serious threat. Vaccination is thought to ...
The Therapeutic Vaccine Potential of MIS416 Adjuvant
Jan 01, 2009; ... By stimulating innate immunity, a new adjuvant may increase the effectiveness of therapeutic vaccines. Abstract There is accelerating interest in the use of nonspecific immunostimulants or adjuvants as a means of enhancing or inducing non-specific immunity. A further requirement ...
Advances in Single-Shot Vaccine Development
Jan 01, 2009; ... Biodegradable microsphere-based systems may eliminate the need for booster shots. Abstract To provide effective patient protection, many traditional vaccines require multiple injections, which results in a costly and inconvenient regimen. These disadvantages have spurred the ...