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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 […]
Antibody-drug conjugates (ADCs) are at the forefront of precision cancer therapy, with more than fifteen ADCs approved globally and over 300 in development. These specialized therapies, designed to target cancer cells precisely, hold immense promise in oncology. However, with the rapid expansion of ADC manufacturing comes a unique set of challenges. The Challenges of ADC […]
As the biopharmaceutical industry grows, single-use technology is becoming increasingly important. From smaller batch sizes used in preclinical and clinical testing to facilities producing multiple products, the need for flexible and adaptable manufacturing solutions has never been greater. Single-use components are crucial, offering increased efficiency, reduced risk of contamination, and lower capital costs. To ensure […]
Silicone is widely used across biopharmaceutical processes for its inert nature and hydrophobicity, making it highly biocompatible.1 And since it’s composed of silica, a substance found in sand, silicone has excellent durability, making it able to withstand extreme chemical and thermal conditions. When choosing components for your workflow, high-purity, robust, biocompatible silicone tubing always delivers […]
Frederica, Delaware- December 16, 2021 – ILC Dover, Inc. (“ILC Dover”, “ILC” or the “Company”), a leading designer and manufacturer of high-performance materials for life critical and primarily life sciences-based applications, today announced the acquisition of KSE Scientific (“KSE”), a sterile solutions manufacturer which specializes in the production of Water for Injection (WFI) and related […]
FREDERICA, Del. & NEW YORK–(BUSINESS WIRE)–ILC Dover announced today that Corey Walker, an experienced executive in life sciences, advanced technologies and applied materials, will join ILC Dover as Chief Executive Officer effective November 15, 2021. Mr. Walker had previously worked closely with New Mountain Capital from 2016 to 2020 while he was a senior executive […]
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 a containment system that does a lot more than transfer powders. DoverPac® was purposely designed for ease of use in handling pharmaceutical products and should not be […]
This presentation of the DoverPac FIBC high containment system for transferring powders describes the unique capabilities in pharmaceutical processes. The DoverPac virtually eliminates cleaning resulting in cost savings and production time efficiencies. The benefits of the flexible wall technology is proven to be the best when filling and discharging poor flowing powders while promoting mass […]
With the development of ILC Dover’s new Aseptic Isolator system new opportunities have opened up for many organizations who were previously unable to conduct fill finish activities due to facility restraints or expensive closed barrier systems. This new technology also allows existing facilities to handle different product previously thought to be ‘out of reach’ in […]
Solo Containment’s Martyn Ryder has been observing environmental monitoring systems from as early as 1989. It was clear from the start that segregation between operators and API powder was the key to reducing occupational exposure. In Ryder’s work, he grasped the importance of maintaining long-term and repeatable safety standards within the pharmaceutical sector. As a […]