GUEST COLUMNISTS

• 5 Hot-Button Issues In Parenteral Packaging

  Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.

• The Global Market For Generic Sterile Injectables To Double In Value By 2032

  According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.

• All You Need To Know About Contamination Control Strategies, Part 1

  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.

• A Digital-First Approach To Bio/Pharma Manufacturing Operations

  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.

• FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs

  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.

• India’s CROs & CDMOs Come Of Age In The Global Marketplace

  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.

• Improving Digital Integration Between Biomanufacturers & Partners

  Sponsors are working with more contract organizations, and contract organizations are working with more sponsors. There is often a mismatch in digital maturity (IT capabilities) between the two sides of a partnership. We must work toward a bidirectional sharing of data and process knowledge. This road map from BioPhorum will help.