PTSM: Pharmaceutical Technology Sourcing and Management-12-07-2016

PTSM: Pharmaceutical Technology Sourcing and Management

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..

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.