Liquid Dose Featured Articles
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All You Need To Know About Contamination Control Strategies, Part 1
5/12/2023
In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.
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A Digital-First Approach To Bio/Pharma Manufacturing Operations
5/10/2023
Features such as real-time data monitoring, cloud solutions, and process integration comprise a digital operational excellence approach that adds value. But successful deployment of these and other digital solutions requires careful, cross-functional collaboration across the full life cycle of the project.
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FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs
5/4/2023
In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.
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India’s CROs & CDMOs Come Of Age In The Global Marketplace
5/4/2023
Most of the top 10 pharmaceutical companies and many large biotech companies today get a portion of their preclinical/clinical research, drug development, and/or manufacturing done in India. While a low price is the initial attraction, there are additional factors that can be more meaningful.
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5 Emerging Trends In Complex Small Molecule Drug Production
5/3/2023
The small molecule landscape is changing in terms of drug product complexity, molecule potency, manufacturing trends, and industry makeup. How the industry responds will shape the next chapter of small molecule drug development.
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Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems
4/20/2023
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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Stability Chambers: Testing, Equipment, And Uses
3/7/2023
Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
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Lyophilization Contract Manufacturing Services: What To Know
3/7/2023
Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
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Meeting The Growing Demand For Pre-Filled Syringes
3/7/2023
The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.