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Tag: cGMP

HPAPI Transfers Webinar: Achieving Zero Cleaning & Superior Powder Flow

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In a recent webinar, DoverPac® for HPAPI Transfers, ILC Dover discussed the two key benefits of DoverPac® technology: superior powder flow properties and zero cleaning.DoverPac technology is purpose-built to handle highly potent active pharmaceutical ingredients (HPAPIs) with precision and safety, streamlining critical transfers in pharmaceutical processes. DoverPac offers high containment, exceptional powder flow, and single-use […]

The Future of ADC Manufacturing

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Antibody-drug conjugates (ADCs) are an advanced cancer therapy designed to precisely target and deliver cytotoxic agents directly to cancer cells. However, this approach introduces significant challenges in manufacturing, particularly in safely handling highly potent cytotoxic payloads. As the number of ADC candidates rises and regulatory safety standards become more stringent, the complexities of ADC manufacturing […]

Webinar: Modern Containment Solutions in OSD Processes

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In this webinar, Scott Patterson, Vice President of Technical Support at ILC Dover, looks at modern containment solutions for handling small molecule oral solid dosages in-depth. With a focus on advanced flexible film single-use isolators, Scott explores strategies for achieving high containment levels, reducing cross-contamination risks, and streamlining operations. The session delves into the evolution […]

Webinar: Solutions for Handling Nanogram-Level Potent Products to Pass Containment Testing Criteria

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In this webinar, Declan O’Shea, Product Manager for Isolators and Containment Systems at ILC Dover, shares his expertise on advanced containment solutions for potent products. He covers strategies for achieving high Occupational Exposure Limits (OEL), meeting stringent SMEAP testing criteria, and developing effective Standard Operating Procedures (SOPs). The session offers valuable insights into balancing equipment […]

Webinar: Handling Potent Products Inside a Sterile Environment

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In this webinar, Declan O’Shea, Product Manager for Isolators and Containment Systems at ILC Dover, discusses the challenges and solutions related to handling potent products within sterile environments. The presentation covers trends in sterile manufacturing, the importance of containment, risk assessments, and the development of specialized equipment and SOPs (Standard Operating Procedures). Watch the video […]

The Importance of cGMP for Pharma Contract Manufacturing

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What is cGMP? The FDA enforces current Good Manufacturing Practice (cGMP) regulations, which ensure the potency, quality, and purity of pharmaceutical products. When outsourcing or partnering with another company, it’s critical to understand their manufacturing practices and facilities before integrating them into your workflow. cGMP compliance eliminates the need for conducting your own investigation of […]

Flexan LLC and ILC Dover Earn Class 7 Certification for Cleanroom in Juarez, Mexico

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Nearshoring Strategy Supports Increased Customer Demand While Upholding Stringent Quality Standards FREDERICA, DEL., – Sept. 26, 2023 – Flexan LLC, a custom contract manufacturer of medical grade silicone and thermoplastic components, and ILC Dover, a leading provider of innovative single-use solutions for biopharmaceutical and pharmaceutical processing, announced that they have successfully attained ISO 13485:2016 certification […]

High Containment and Cost Savings With Single-Use Isolator Technology

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As the potency of drug substances continues to increase, so does the requirement for containment solutions that reduce cross-contamination risks without breaking the bank. ILC Dover would like to share with you an exclusive whitepaper providing the data supporting flexible containment solutions, as well as cost analyses of single use systems vs cleaning and validation. […]

Pharmaceutical Powder Containment: Vital for Protecting People and the Bottom Line

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Single-use powder transfer bags can be removed, discarded and replaced when a manufacturing process is finished. One word frequently surfaces during discussions on pharmaceutical manufacturing. That word? Containment. Because confining the toxic substances involved in the manufacturing process— like powder, dust and vapors—is a necessity for safety. And even microscopic amounts of those materials that […]

Webinar: Improving Efficiency In Media and Buffer Production To Enable You To Get To Market Rapidly

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In this webinar, ILC Dover’s Regional Sales Manager, Dave Howes, presents innovative solutions for handling powders in the biopharmaceutical industry. The discussion focuses on the challenges associated with increasing volumes of powder used in biologics processing compared to liquid handling. Howes highlights industry trends such as the shift towards large-scale single-use manufacturing and closed systems […]