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March 21, 2022

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eBook: Cleaning Validation with TOC – Lab, Online, At-line Analysis

Total organic carbon (TOC) and conductivity are important quality metrics for assessing cleanliness of equipment. Unlike product-specific analytical methods, TOC gives a comprehensive understanding of cleanliness and process efficiencies. Whether new to cleaning validation, transitioning from HPLC to TOC, or moving from laboratory analysis to online, this eBook guides you through the essentials of TOC for cleaning validation.

	Industry News

Akston Biosciences and Biolexis Collaborate to Launch a Room Temperature Stable 2nd Generation COVID-19 Vaccine in 130+ Countries
Akston Biosciences Corporation and Biolexis, a division of Stelis Biopharma Limited have entered ... read more »

AstraZeneca Reaches Settlement Agreement Resolving Patent Litigation Related to Ultomiris
Alexion, AstraZeneca’s Rare Disease group, has entered into a settlement agreement with Chugai ... read more »

Armas Pharmaceuticals and Steriscience Enter Strategic Partnership to Commercialize Products for the U.S. Market
Armas Pharmaceuticals, Inc. and Steriscience have announced an exclusive partnership for the ... read more »

The Bioindustry's Most In-Depth, Global Benchmarking and Analysis Study
Your input is important as we benchmark current global and regional trends affecting the bioindustry... read more »

	Infographic

Transition to Recombinant rFC for Endotoxin Testing: The Sustainable Choice
Transition to Recombinant rFC for Endotoxin Testing: The Sustainable Choice
Recombinant Horseshoe Crab Factor C (rFC) provides a sustainable, highly effective, and environmentally friendly sustainable means of endotoxin ... read more »

	Featured Articles

Purification Strategies for Recombinant Therapeutic Proteins Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various steps of the pharmaceutical value chain, from drug... read more »

Improving Preclinical Drug Safety by Evaluating Cytokine Release Syndrome in Humanized Mice The human immune system is a powerful, intricate defense system that is effective against a wide range of microorganisms and other invading ... read more »

	Featured Video

On-Demand Webinar: Microbial Identification in a Manufacturing Environment
In this webinar we will discuss how recent technological developments allow for rapid micro testing and rapid micro identification, focusing on the ... watch »

On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

	Featured Products

Luminata Product Development Software
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	Featured Whitepaper

Whitepaper: Global regulators’ FAQs on CMC in IND/BLA filing
Mammalian cell cultures used in the manufacturing of therapeutics must be tested to ensure lack of mycoplasmal contamination. Previously, the only test for mycoplasma accepted by regulatory agencies ... read more »

eBook: Analytical Method and QC Testing Strategies for Biologics Production
Development of a manufacturing process for a biotherapeutic that ensures consistent quality, purity and safety is a critical step in successfully developing the drug, getting it approved by regulatory... read more »

	Events

SMi’s 9th Annual Conference Pre-Filled Syringes East Coast
Boston, MA – 04/25/2022
The global pre-filled syringes market was valued at $1139.6 million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR ... event details »

SMi’s 6th Annual Highly Potent Active Pharmaceutical Ingredients
London, UK – 05/09/2022
The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. The expanding ... event details »

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