The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
The FDA issued MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved.
The inaugural West Coast meeting for the Clinical Supplies Support Group (CSSG, www.jeiven.com/clinical_supplies_support_group.htm) was held in San Diego on June 8, 2007.
The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) has issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use.
One goal of process characterization is establishing representative performance parameter ranges that can be used to set validation acceptance criteria (VAC). Characterization studies yield varying numbers of data points from multiple experiments, and may also include data generated at different scales (e.g., bench, pilot, and commercial), which add complexity to the analysis. Many statistical approaches can be used to set ranges from large data sets. As an example, we present the statistical considerations and techniques for setting validation acceptance ranges for a chromatography step used in purifying a recombinant protein. Performance parameter data from a combined data set consisting of 67 bench, six pilot, and three full-scale runs were analyzed using the statistical analysis software JMP (SAS Institute). The combined data set was used to compute tolerance intervals, so that sources such as scale and column feed material could be properly modeled. The resulting ranges were used to establish..
Outsourcing has been a cornerstone of our industry for decades.
FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.
Following the US Senate approval of the FDA Revitalization Act (FDARA, S.1082) in May, the debate over drug safety and the reauthorization of the Prescription Drug User Fee Act (PDUFA) now moves to the House.
Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies.
The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.
Lax enforcement arising from a lack of political will creates the potential for a loss of public confidence.
In March, the US Food and Drug Administration released a new draft guidance, along with its guidance agenda for the year.
Neotropix, Inc. (Malvern, PA, www.neotropix.com), a biotechnology company dedicated to the development and commercialization of virus-based therapeutics for the treatment of cancer and other diseases, received a warning letter (http://www.fda.gov/foi/warning_letters/b6308d.pdf) on March 23, 2007, citing deviations from good laboratory practices (GLP) regulations governing the proper conduct of nonclinical studies as published under 21 CFR Part 58.
A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity-characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.
The challenge will be to design a system that is flexible, yet appropriate, for the broad range of biological products and the varying quality control capabilities of different manufacturers.
Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.
Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.
The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship.
The US Food and Drug Administration (Rockville, MA, www.fda.gov) commemorated its 100th anniversary in 2006 as America's premier public health agency aimed at protecting and promoting public health.
The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides.
All contributors to the process should have a clear understanding of their capacity and see their work activities as a priority, regardless of where they fall on the critical path.
Disposables are no longer a mistrusted new technology; they're seen as a potential solution to everyday problems.
Although IP due diligence is relevant to virtually any transaction between biotech companies, a detailed investigation into IP assets is particularly critical to M&A transactions.
An underlying theme of FDA's drug safety program is that new discoveries in biomedical science can detect risk issues earlier in clinical development.
A series of ICH guidances are encouraging industry to adopt quality-based approaches for achieving the "desired state" of drug and biotech manufacturing: more efficient and flexible operations that can reliably produce high quality therapies with less regulatory oversight.
