In the Lab

Evolution of Analytical Tools Advances Pharma, But Challenges Remain

Technology improvements in analytical testing tools have helped increase understanding of molecules and speed up development processes.
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Managing Risk for Biomanufacturing Raw Materials

USP is developing new guidelines to help organizations prioritize risk and ensure raw material quality.
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SGS Expands Bioanalytics Capacity

The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.
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Cambrex Invests in Analytical Laboratory Expansion

Cambrex will expand its High Point, NC, facility with a $3.2-million, 11,000 ft.² analytical laboratory.
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Supply Chain Update

FDA Releases Supply Chain Guidance

The agency published guidance on identifying trading partners under DSCSA.
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Trek Therapeutics to Test Blockchain-Based Smart Contracts for Clinical Supply Chain Safety

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
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Drug Supply Chain Tracking Challenges FDA and Manufacturers

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
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APIs & Excipients

Reducing Risks Inherent with Cell-Culture Media

Media manufacturers improve processes and technologies to reduce risks and improve quality and consistency, while managing costs.
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Outsourcing Update

Flexibility and Innovation Needed to Solve Manufacturing Uncertainity

Matching the production requirements of a bio/pharma company with the manufacturing capabilities of a CMO is a delicate balance, requiring attitude shifts on both sides of the table.
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Contract Services Update

Corden Pharma Facility in Italy is Cleared by FDA

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.
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Thermo Fisher Scientific Acquires Patheon

Thermo Fisher Scientific has completed the previously announced acquisition of Patheon for approximately $7.2 billion.
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Swiss CDMO Expands GMP Manufacturing Capabilities

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.
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Charles River Labs Acquires CRO

Charles River Labs has announced the acquisition of Brains On-Line (US), a contract research organization (CRO) that provides data on therapeutics for treating central nervous system (CNS) diseases.
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