This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.
In Nov. 2018, The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-dug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. This piece highlights technology opportunities for gene therapy manufacturing.
The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality. In the guidance, CDER states its belief that recognition of voluntary consensus standards “will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications.”
Many pharma companies struggle to strike the right balance between enough preventative maintenance and not too much corrective maintenance for manufacturing equipment, and to achieve that balance at a reasonable cost. One method known to drive the preventative/corrective ratio in favor of preventative maintenance is centerlining.
Bioburden is mobile, growing, contaminating, and touching everything we do, but it can be controlled if we understand it and follow some basic concepts. This article will focus on the EU grades B, C, D, and CNC in biotech and aseptic facilities.
In recent months, the U.S. Food and Drug Administration has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P), many of which are used in orthopedics.
This article is the first part of two-part article that will discuss objectionable microorganisms recovered from nonsterile products. In this part, we will explore what constitutes an objectionable microorganism, as well as the regulatory expectations for objectionable microorganisms in nonsterile products.
The viability and cell count of immunotherapies are extremely sensitive to temperature. Additionally, these products demonstrate reactivity to cooling and thawing rates between room temperature and refrigerated/frozen temperatures.1 The same sensitivity applies to apheresis material, which is susceptible to failure if not fully protected against temperature fluctuations.
The U.S. FDA issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (“guidance”). This update is the FDA’s second attempt at a policy for nonproprietary name suffixes for biologic products. It also highlights the perceived tension between the FDA’s pharmacovigilance role and its goal of increasing the availability of biosimilars. At least for this round, the FDA’s interest in tracking pharmacovigilance data seems to have received priority.
The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.
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