The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.
- Impurity Control Strategies For Therapeutic Peptides
- FDA Seeks Comment On Conducting Remote Regulatory Assessments
- Tools & Techniques For Biopharma Root Cause Analysis
- The Promising Emergence Of Venom-Derived Compounds
- What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I
- Your 3-Step Process For Innovation In Precision Medicine
- Data: The Near Future Of Regulatory Info Management In Europe
Impurity Control Strategies For Therapeutic Peptides
Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate from raw materials, manufacturing processes, degradation, and other causes. This article shares perspectives and recommendations discussed at USP's recent 2022 workshop on the topic.
FDA Seeks Comment On Conducting Remote Regulatory Assessments
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
Tools & Techniques For Biopharma Root Cause Analysis
In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.
The Promising Emergence Of Venom-Derived Compounds
There are 100,000+ venomous animal species, each producing a chemical cocktail of up to 1,000 different components, including peptides, proteins, and non-peptide small molecules. Many in drug development view venom-derived compounds as simple peptides that will be easily digested, limiting their therapeutic potential. This article dispels that myth.
What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I
One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
Your 3-Step Process For Innovation In Precision Medicine
Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts?
Data: The Near Future Of Regulatory Info Management In Europe
Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.
Heightened Standards For Satisfying Written Description In Pharma Patents
In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.
PHARMA ONLINE WHITE PAPERS
Trends In Single-Use Mixing Technologies
Here we present an overview of the current mixing technology landscape driven by the need for versatile biomanufacturing platforms with increased productivity.
Assembling The Right Team For A Successful Nonclinical Program11/18/2021
Discover insight into the importance of nonclinical studies and review recommendations for assembling a nonclinical program team that optimizes the likelihood of moving candidates into clinical trials.
A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter12/4/2021
A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more.
Considerations And Steps For Building A Contamination Control Strategy4/22/2021
Contamination control strategies (CCS) are designed to prevent and control potential contamination from reaching the point of no return: the product. Once contamination occurs, there is no cost-effective removal scheme to continue production, making the determination of sources all the more important. Learn how to create an effective CCS.
Streamlining Upstream Plasmid DNA Manufacturing12/9/2021
Here we will discuss the scalable process workflow solutions available from initial R&D investment to clinical testing and commercialization.
Risk Assessment As A Process Quality Assurance Tool8/12/2022
Discover how an effective approach to risk management can further ensure delivery of a high quality drug or medicine to the patient.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.More Content Collections