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ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee ( E55 ) has approved a new standard that will help advance the use of continuous manufacturing (CM) technologies in the biopharmaceutical industry. In a CM process, individual unit operations are integrated into a connected flow which provides multiple efficiencies in terms of scale and productivity. “…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #11543 ###
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A proposed ASTM International standard will help advance the concept of lyophilization (freeze-drying) as it is used in the pharmaceutical and biotechnology industries. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products ( E55 ) is developing the proposed standard. “The proposed standard will promote a deeper understanding of the science and engineering of…
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A proposed ASTM International standard will be used to aid physical integrity testing of single-use systems (SUS) in the pharmaceutical and biopharmaceutical industries. SUS equipment has become a popular alternative to stainless steel equipment that has been generally used for biopharmaceutical manufacturing processes. ASTM International’s committee on manufacture of pharmaceutical and…
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A new standard guide developed by ASTM International’s nanotechnology committee ( E56 ) seeks to familiarize laboratory scientists with background information and technical content necessary to image and identify engineered nanomaterials in cellular and noncellular samples. The standard ( E3275 ) is specific to the use of the darkfield microscopy/hyperspectral imaging analysis technique. In this…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; mlynyak@astm.org Release #11273 ###
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A new ASTM International standard will support the characterization of engineered gold nanoparticles used in advanced technologies, including biomedical applications. ASTM’s nanotechnology committee ( E56 ) developed the new standard ( E3269 ). Gold nanoparticles are being used in electronics, catalysis, and advanced coatings, but the largest application has been for biomedical purposes. These…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org , Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11258 ###
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A new ASTM International standard will aid the pharmaceutical industry by describing best practices in monitoring process and product condition during freeze-drying. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which focuses on methods that apply to both laboratory and production environments. “The new standard provides guidance on…, Media Inquiries:, Jaime Martorana, tel +1.610.832.9796; jmartorana@astm.org , Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #11246 ###
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A new ASTM International standard test method will support the measurement of nanoparticle-based products used in a wide range of applications from cancer therapy to antibacterial coatings in textiles. ASTM’s nanotechnology committee ( E56 ) developed the new standard, which was recently published as E3247 . According to ASTM International subcommittee co-chair Vince Hackley, the standard will be…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Kathleen Chalfin, tel +1.610.832.9717; kchalfin@astm.org Release #11122 ###
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A new ASTM International standard will help keep foreign particles out of biopharmaceuticals during the single use system (SUS) manufacturing process. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which will soon be published as E3230. According to ASTM International member Klaus Wormuth, over the last 10 years, single-use…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Committee Contact:, Travis Murdock, tel +1.610.832.9826; tmurdock@astm.org Release #11021 ###
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In light of COVID-19 (coronavirus) and ongoing safety concerns for members and staff, ASTM International announced today that all previously scheduled in-person May standards development meetings (including independent meetings) have been canceled. Earlier this month, ASTM International announced the cancellation of all April in-person meetings . These decisions were based on several factors,…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #11001 ###
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In light of COVID-19 (coronavirus) and growing safety concerns for members and staff, ASTM International announced today that previously scheduled April standards development meetings in Boston (March 29-April 3) and Prague (April 27-30) have been canceled. The decision was based on several factors, including, but not limited to: Continued review of information and recommendations from the U.S.…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10993