Industry Insights

81. Achieving New Heights By Expanding Services, Talent, And Facilities 4/20/2023

    As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

82. Polymeric Implants, Formulations For Intravitreal Administration 2/17/2021

    Polymeric formulations such as intra-ocular implants designed for the precise intravitreal delivery of drug products represent one of the most promising, yet challenging, areas of pharmaceutical focus.

83. Key Offerings To Help Support Your OSD On Its Journey To Market

    Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.

84. Building A Global Cell And Gene Supply Chain Serving Personalized Medicine 3/28/2022

    Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.

85. Insights Into The Competitive Clinical Manufacturing Market

    There are perhaps too many options when it comes to choosing the right service provider for clinical manufacturing. Drug innovators weigh in on their selection metrics and preferences as well as reveal why vendors lose bids.

86. 3 Problems To Avoid When Establishing A Quality System 10/23/2012

    For some products on the market, quality is a luxury or an option. However, when your product is under the FDA umbrella, quality is required by law if you want to do business in the United States. In the pharmaceutical industry, the customers we serve have very precise expectations when it comes to product quality — nothing but the best, with the highest standards of production and manufacturing. Because the end product affects people's lives, pharma companies aren’t afraid to pay whatever it takes to achieve quality.

87. Effective Cleaning Strategies For Irregular Surfaces In Cleanrooms 8/6/2024

    Explore effective strategies and cleaning supplies to ensure irregular cleanroom surfaces, such as light switches, door handles, valves, and piping, maintain the same standards as more accessible areas.

88. 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.

89. Cleaning And Disinfection Protocols For Annex 1 2/27/2023

    The new GMP regulations coming out of the European Union will have a big impact on pharmaceutical manufacturers. Learn about executing a CSS, cleaning, disinfection, and much more.

90. Sustainable Pharmaceutical Packaging

    The concept of sustainability has been a topic of interest for many years. Cur-rent international focus has led to the development of regulatory guidance in many of the world’s markets. Along with sterility assurance, process validation, and regulatory compliance, sustainability is becoming a high-profile issue and is considered a critical factor in the design of healthcare facilities, equipment, products, and packaging. By Chuck Reed and Mel Bahr