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Considerations For Microbial Enumeration Methods When Working With CDMOs
1/23/2023
In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.
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What's Behind The ASTM E3263 Standard Revision?
1/17/2023
ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.
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Considerations For Sterility Test Methods When Working With CDMOs
1/13/2023
Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.
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FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
1/11/2023
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
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Calculating The Probability Of Passing The USP Dissolution Test
1/9/2023
Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.
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FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
1/9/2023
The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
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CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance
12/21/2022
While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.
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6 Tips For Successful Drug Discovery Teamwork
12/16/2022
While people don’t always think about the choreography of good scientific teamwork, there are factors that should be considered and skills that can be developed to increase a drug discovery team’s overall effectiveness and chance of success.
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ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products
12/8/2022
Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).
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Assessing Quality Of Viral Vectored Vaccines
11/11/2022
While viral vectored vaccines have been previously developed against Ebola virus, the COVID-19 vaccines were the first widespread global application of this vaccine platform. Adenovirus vectored vaccines have unique critical quality attributes that must be tested to ensure quality and safety.