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PTSM: Pharmaceutical Technology Sourcing and Management-12-07-2016
PTSM: Pharmaceutical Technology Sourcing and Management
Factors to Consider in Dissolution Testing
December 07, 2016
In the Lab
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Principles of dissolution testing, including method development and testing apparatus, are reviewed.
Internal and External Factors to Shape CMO Industry
December 07, 2016
Outsourcing Update
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M&A activity, new business models, fundraising limits, offerings from small CDMOs, and combination products are driving decisions in the contract services market..
New Opportunities for Cocrystals
December 07, 2016
API Synthesis and Manufacturing
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Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.
Analytical Method Validation Using QbD and QRM
December 07, 2016
In the Lab
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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.
Recipharm Collaborates with Laccure AB
December 02, 2016
Contract Services Update
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Recipharm and Laccure AB signed a commercial collaboration for the manufacture and delivery of Laccure’s bacterial vaginosis treatment.
Vetter Processing Center Receives Data Certification
December 02, 2016
Contract Services Update
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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.
Idifarma Invests in Automatic Capsule Filling Capabilities
November 30, 2016
Contract Services Update
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Idifarma has acquired a Bosch GKF-702 capsule filling machine that can manufacture 3000 to 42,000 capsules per hour.
Catalent Expands Softgel Capacity with Accucaps Acquisition
November 28, 2016
Contract Services Update
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Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.
Patheon Acquires Roche API Site
November 28, 2016
Contract Services Update
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Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.
FDA Guidance Helps Further Clarify Quality Agreements
November 28, 2016
Outsourcing Update
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Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor
PCI Expands Cryogenic Storage Facilities to Rockford Site
November 25, 2016
Contract Services Update
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PCI is extending its cryogenic storage capabilities to its Rockford, Illinois operations to support storage and distribution of clinical trial materials.
Almac Expands Commercial Packaging Facility
November 17, 2016
Contract Services Update
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The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.
EAG Laboratories Opens Dedicated ICP-MS Lab
November 10, 2016
Contract Services Update
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Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.
GS1 Releases New DSCSA Guidelines
November 09, 2016
Supply Chain Update
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GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.
UPS to Acquire Marken
November 07, 2016
Supply Chain Update
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UPS entered into a definitive purchase agreement to acquire Marken, a provider of supply-chain solutions for the life-science industry.
Lonza Holds Grand Opening of New Drug Product Services Labs
November 04, 2016
In the Lab
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The new facility will focus on formulation development, drug product analytical development, and quality control.