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American Pharmaceutical News In Review
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April 25, 2023
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Newsletter Sponsor
  Advanced Recombinant Reagent for Bacterial Endotoxins Test
Sponsored by Associates of Cape Cod, Inc.
Previous reports indicate that recombinant reagents have two issues: extremely low endotoxin potency determination for Helicobacter pylori GU2 and high levels of interference from Heparin Calcium impacting endotoxin recovery. A new recombinant cascade reagent (rCR), PyroSmart NextGen®, recently introduced to the market, has been developed to solve these issues.

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» Industry News
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  Lilly to Invest $1.6B in Indiana Manufacturing Facilities
Eli Lilly and Company announced that it will invest an additional $1.6 billion and add another 200 ... read more »
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  FDA Approves Omidubicel for Patients with Hematologic Malignancies
The FDA approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric ... read more »
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  FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
The FDA amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 ... read more »
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  Premier Research Adds to Cell and Gene Therapy Leadership Team
Premier Research announced the addition of Kenneth Ndugga-Kabuye, M.D., FACMG, as VP, Cell & Gene ... read more »

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» QC Corner
QC Corner
  QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

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» Infographic
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  Poster: Adoption of ATP Bioluminescence Technology
SQZ Biotechnologies has successfully adopted the established Milliflex® Rapid ATP Bioluminescence based RMM (Rapid Microbiological Method) technology ... read more »
» Featured Articles
EVENT   Applying Process Analytical Technology in a Phase 1 Cell Therapy Facility
The latitude to optimize a manufacturing run in response to in-process test results is often omitted from cell therapy INDs in exchange for speed to ... read more »
EVENT   A Green Solution for the Dissolution Laboratory
Going “Green” in today’s business climate where maximizing shareholder equity and conserving capital is a top priority can be difficult, especially if... read more »
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» Featured Video
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  On-Demand Webinar: Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy
In this webinar, hear from Lisa McChesney-Harris, PhD, CEO, CSO & Founder, as she discusses Organizational Readiness for an FDA Audit of a 503B ... watch »
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  On-Demand Webinar: Implementing a Recombinant Cascade Reagent for BET
In this live webinar, hear from Veronika Wills as she discusses Implementing a Recombinant Cascade Reagent for BET. watch »

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» Featured Products
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  Model 2500 Select Bathless Dissolution System
Distek, Inc. Offering maximum flexibility and configurability, the Distek Model 2500 Select - Bathless ... learn more »
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  BIOne 1250 Bioprocess Control Station
Distek, Inc. BIOne 1250 Controllers are compatible with both autoclavable and single-use vessels. The systems are... learn more »
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  Maisine® CC
Gattefossé Maisine® CC is an oily vehicle used to enhance the solubility and oral bioavailability of ... learn more »

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» Featured Whitepaper
EVENT   App Note: Mold Detection in Real Time
Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. RMBNucleusTM Mold Alarm allows investigations to begin in as little as one ... read more »
EVENT   eBook: How a CDMO Can Help Overcome LNP & Liposome Challenges
The articles in this publication provide an overview of how a CDMO can help overcome LNP & liposome challenges. read more »

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» More Products
Ascentis Express OH5 HPLC Columns Learn More
PC-10 Pregelatinized Starch Learn More
ITS Universal Cell Culture Supplement Premix Learn More
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» Directory Categories
Endotoxin Detection and Testing Search More
Growth Promotion Test in Microbiology Search More
Pharmaceutical Excipients Search More
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| Events
EVENT
  BIO International Convention
Boston, MA –  06/05/2023
Stand up for innovation. Stand up for truth. And stand up for science. It’s time to inspire, honor, and recognize the true value of the breakthrough ...
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EVENT
  ISPE Annual Meeting & Expo
Las Vegas, Nevada –  10/15/2023
The 2023 ISPE Annual Meeting & Expo is focused on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the ...
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