In the Lab

Analytical Method Validation Using QbD and QRM

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.
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Factors to Consider in Dissolution Testing

Principles of dissolution testing, including method development and testing apparatus, are reviewed.
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Lonza Holds Grand Opening of New Drug Product Services Labs

The new facility will focus on formulation development, drug product analytical development, and quality control.
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API Synthesis and Manufacturing

New Opportunities for Cocrystals

Previous hesitation by pharma industry to use cocrystals may change with FDA's new guidance that classifies cocrystals as APIs.
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Outsourcing Update

Internal and External Factors to Shape CMO Industry

M&A activity, new business models, fundraising limits, offerings from small CDMOs, and combination products are driving decisions in the contract services market.
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FDA Guidance Helps Further Clarify Quality Agreements

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor.
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Supply Chain Update

GS1 Releases New DSCSA Guidelines

GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.
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UPS to Acquire Marken

UPS entered into a definitive purchase agreement to acquire Marken, a provider of supply-chain solutions for the life-science industry.
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Contract Services Update

Vetter Processing Center Receives Data Certification

Vetter's Ravensburg data processing center received certification from a German industrial testing organization, certifying that the company's customer and process data are protected.
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Recipharm Collaborates with Laccure AB

Recipharm and Laccure AB signed a commercial collaboration for the manufacture and delivery of Laccure's bacterial vaginosis treatment.
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Idifarma Invests in Automatic Capsule Filling Capabilities

Idifarma has acquired a Bosch GKF-702 capsule filling machine that can manufacture 3000 to 42,000 capsules per hour.
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Catalent Expands Softgel Capacity with Accucaps Acquisition

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.
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Patheon Acquires Roche API Site

Patheon adds API manufacturing capacity with acquisition of Roche's Florence, SC facility.
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PCI Expands Cryogenic Storage Facilities to Rockford Site

PCI is extending its cryogenic storage capabilities to its Rockford, IL operations to support storage and distribution of clinical trial materials.
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Almac Expands Commercial Packaging Facility

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.
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EAG Laboratories Opens Dedicated ICP-MS Lab

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.
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