The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards.
Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various factors that influence sterile filtration.
Calculations show the predicted contamination levels in cleanrooms with turbulent mixing air and with vertical unidirectional airflow when people are dressed in modern cleanroom clothing systems. Comparisons are made between operation theatres and cleanrooms.
The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.
There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility.
The biotechnology company Discovery Laboratories Inc. (Warrington, PA, www.discoverylabs.com) reports that analysis of ongoing stability data from "Surfaxin" process validation batches indicates that certain stability parameters have not been achieved, and additional process validation batches will likely have to be produced.
Agilent Technologies Inc. (Palo Alto, CA, www.agilent.com) announced April 17 that it acquired SynPro Corp. (Boulder, CO), a contract manufacturer of oligonucleotide active pharmaceutical ingredients. Earlier, Dalton Pharma Services (Toronto), announced that it had completed a multi-gram CGMP oligonucleotide production facility.
Novartis (Basel, Switzerland) has closed on its $5.4-billion acquisition of Chiron Corporation (Emeryville, CA), paving the way for the creation of a new Novartis division focusing on vaccines and diagnostics.
Reverse Genetics Avian Influenza Vaccine Approved in France
GSK Begins Clinical Trials of Two H5N1 Vaccines
The need to curb drug counterfeiting is spurring development of track-and-trace and product authentication technologies.
Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles.
Despite worries that industry is slow to adopt anticounterfeiting technologies, the 2006 Interphex program is rife with new methods for securing the supply chain.
Absorption promoters and enhancers and enzyme inhibitors, either alone or in combination, can play an important role in improving the bioavailability of oral insulin.
Senior management must be the champions of change in companies that are struggling financially or organizationally.
Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.
The right choice [of coding and marking technology] depends upon the company's top priorities regarding legibility, cost, speed, ease of use, cleanliness and security.
Creation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
Once the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.
Progress Continues in Vaccine and Antiviral Development
Implementing a PAT Strategy
RFID and the Future of Pharmaceutical Supply Chains
Chiron Withdraws Measles Vaccine
Development Begins on Mutated H5N1 Virus Vaccine
Proposed Legislation to Help Fight Counterfeit Drugs
