Newsletter | March 29, 2024

03.29.24 -- FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

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Webinar: Instant Implementation Of RAMAN-Based Monitoring And Control For Key Upstream Bioprocessing Parameters

Join us as we discuss the benefits of MAVERICK, a novel Raman spectroscopy-based PAT solution that can be easily deployed without bioprocess-specific model building. Learn how this platform effortlessly operates as a pH-meter, providing real-time measurements of key process parameters. Discover how it provides access to high-quality, full-spectrum Raman data, facilitating comprehensive bioprocess development. Click here to learn more.

FEATURED EDITORIAL

FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

Recently, FDA asked the USP to adjust the compendium amid safety concerns related to benzene's carcinogenicity. The agency also issued a new guidance to aid in reformulating affected drug products.

INDUSTRY INSIGHTS

The Case For Early Use Of cGMP Raw Materials

Using cGMP grade reagents earlier makes for a seamless transition while maintaining quality and viability. Learn the key considerations to using high quality reagents ahead of time.

A CDMO’s Checklist For Prospective Clients

Delve deeper into the crucial elements of transparency that prospective clients should consider when partnering with a CDMO, including analytics, documentation, and more.

Recombinant (Synthetic) LAL Vs. Traditional LAL Assay

What are the key differences between traditional Limulus amebocyte lysate (LAL) assays and recombinant LAL assays for endotoxin testing? 

Pursuing Hybrid Funding Models With Silence Therapeutics’ Craig Tooman

Without the resources needed to break through a competitive and volatile market, many nascent biotech companies and promising therapeutics can stall out well before reaching their commercial potential.

Propelling Gene Therapies From Lab To Clinic

Many companies are turning to CDMOs to optimize biomanufacturing processes and address the growing list of complications on the path to commercialization.

Stem Cell Cultivation In Single-Use Stirred Tank Bioreactors

Explore a study aimed at achieving clinically relevant cell numbers using the engineering of a GMP-compliant large-scale platform is essential.

Idea To Clinic: Accelerate Your Manufacturing Timeline To FIH Studies

Translating novel drug discoveries into clinical trials remains a complex endeavor. Learn how a CDMO with cutting-edge technologies can facilitate a smooth path from discovery to FIH studies.

Improved Design And Production Of Bispecific Therapeutics

See how bispecific pairing technology uses a close-to-nature design solution to deliver high accurate heavy-light chain pairing efficiencies and improved manufacturability.

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U.S. Biopharma Workforce Partnership Conference: April 17 and 18

Registration is open for a novel talent acquisition partnership conference this April orchestrated by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The two-day conference in Boston brings together the industry with a myriad of biopharma-savvy universities, community colleges, and non-profits. The conference will be of keen interest to technical hiring managers, recruiters, and HR professionals.

SOLUTIONS

Life Sciences Manufacturing Excellence Platform

Set Of 96-Well Plates Prefilled With Six Different HIC Resins For HTPD

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