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American Pharmaceutical News In Review
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September 20, 2023
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  Who Brings Stability to Your Biologic? We Do.

Vialose™ trehalose dihydrate is a functional excipient used to protect and stabilize recombinant proteins and monoclonal antibodies(mAbs) from degradation and aggregation. Manufactured in the United States according to USP-NF <1078> and The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, it is compliant with NF, EP, JP, and ChP monograph requirements and meets high-quality standards for low bioburden and endotoxin.

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» Industry News
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  ALSA Ventures Launches Gene Therapy Company
ALSA Ventures, a UK-based, therapeutics-focused venture capital fund, announced the acquisition of ... read more »
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  Nexcella Completes 2nd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site
Nexcella, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development ... read more »
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  First Wave BioPharma Licenses Capeserod from Sanofi
First Wave BioPharma, a clinical-stage biopharmaceutical company specializing in the development of ... read more »
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  FDA Approves New And Updated Indications for Temozolomide Under Project Renewal
The FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an ... 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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» Featured Announcements
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  White Paper: The Value and Benefits of Rapid Mold Detection in the Pharmaceutical Industry
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In the pharmaceutical industry, upholding a clean and sterile environment is of paramount importance to guarantee product quality, safety, and effectiveness. Mold contamination poses a substantial risk to pharmaceutical manufacturing facilities, as ... read more »
» Infographic
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  Data Integrity in Pharmaceutical Quality Control
This infographic gives an overview on important terms and definitions, points of compliance, and ways to achieve quality control and data integrity. read more »
» Featured Articles
EVENT   Designing an Environmental Monitoring Solution for GMP Applications
With the release of the new EU GMP Annex 1 revision, a review of current practices is required to ensure that the installed monitoring system, chosen ... read more »
EVENT   Design And Evaluation of a Disinfectant/Sporicide Combination Triple Sanitization And In-Situ Disinfectant Validation
There remains debate on both how to conduct a triple clean evaluation as well as what data generation is optimal during the process in order to ... read more »
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» Featured Video
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  On-Demand Webinar: Particle Analysis Assisted by AI/ML in Solid Dosage Formulation and Manufacturing
Learn from a panel of pharmaceutical industry leaders about the importance of particle analysis and advances in AI/ML in the formulation and ... watch »
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  On-Demand Webinar: The Fast Track to IND: Accelerated CLD Development through the Early Identification of High Producers
Learn about Sartorius’ innovative automated cell line development (CLD) service and media with a successful track record on many CHO-based protein ... watch »

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» Featured Products
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  ExPERT STx™ Electroporation System
MaxCyte, Inc The industry’s leading scalable electroporation technology for high-yield, transient expression of ... learn more »
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  ExPERT GTx™ Electroporation System
MaxCyte, Inc From product development to translation into clinical trials, GTx’s clinically validated scalable ... learn more »
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  BRAND® HandyStep® Touch Electronic Repeating Pipette
BRANDTECH® Scientific The BRAND® HandyStep® Touch and Touch S are the first electronic repeating pipettes with touchscreen... learn more »

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» Featured Whitepaper
EVENT   Article: Addressing Challenges with Clinical In-Use Testing of Biotherapeutics
Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Lea shares her expertise and describes the key elements to support superior product ... read more »
EVENT   Whitepaper: Use of Laboratory Balances in the Pharmaceutical Industry
Pharmacopoeias are collections of recognized and binding quality regulations that specify, among other things, test requirements and methods for the analysis of drugs. Both the European Pharmacopoeia... read more »

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» More Products
USP 3 BIO-DIS II Dissolution Apparatus Learn More
Affinity Isothermal Titration Calorimeter Learn More
1290 Infinity II Autoscale Preparative LC/MSD System Learn More
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» Directory Categories
Microbial Detection Systems Search More
Growth Promotion Test in Microbiology Search More
Pharmaceutical Excipients Search More
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| Events
EVENT
  AAPS PharmSci 360
Orlando, FL –  10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ...
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EVENT
  SciX 2023
Sparks, NV –  10/08/2023
SciX 2023 will be in Sparks, Nevada October 8-13, 2023 – our 50th Annual Meeting! This leading conference presented by FACSS has world-class technical...
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