Industry Insights
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Data Integrity: Surveying The Current Regulatory Landscape
8/4/2016
This review of recent regulatory actions related to data integrity first explores data integrity deficiencies cited in FDA warning letters issued between FY2013 and FY2015. Then, it moves to a review of the recently published FDA draft guidance on data integrity. Finally, it addresses the finalized version of the WHO guidance on the topic.
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New Biologic Drugs: Regulatory Challenges And Considerations
9/30/2019
Along the drug candidate development journey there are many regulatory milestones and hurdles. Here are some tips to assist with up-front planning to alleviate headaches down the road.
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Can Your In-House Strategy Handle Uncertainties Of Biologics Development?
To avoid costly mistakes and wasted efforts, a company must prepare for any surprises along the drug development pathway. One way to accomplish this is to diversify its strategies rather than develop only a single-pronged attack for launching a product. But is it possible to achieve efficiency and flexibility within a drug developer’s own walls, or is outsourcing pharma’s best not-so-secret weapon against today’s development uncertainties?
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SUS Assurance: Improving Supply Chain Management
3/16/2022
Locking in the supply to support crucial production components in a landscape beset with unprecedented demand requires cross-functional, collaborative solutions from the industry’s biggest players.
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6 Simple Ways To Get Millennials (More) Invested In Quality
2/19/2018
Much has been written about millennials — how they think, what motivates them, and their outlook on life. How can we best prepare them for today’s pharma/biotech manufacturing environment so they are successful?
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products
1/18/2023
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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AI/ML In Drug Discovery & Development: Potential And Challenges
1/11/2023
Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.
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Impurity Control Strategies For Therapeutic Peptides
8/12/2022
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.
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What Your CMO Needs To Know About Serialization And Aggregation
Partnering with a CMO that has applied traceability, serialization, and aggregation standards across its operations promises business continuity and speed-to-market that translates to a competitive advantage.
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Debunking Myths And Misconceptions About Softgels
Here, we take a look at some common myths about softgels and explore why drug developers may want to reconsider their go-to delivery methods.