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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
PTSM: Pharmaceutical Technology Sourcing and Management
December 07, 2016
In the Lab
Principles of dissolution testing, including method development and testing apparatus, are reviewed.
M&A activity, new business models, fundraising limits, offerings from small CDMOs, and combination products are driving decisions in the contract services market..
API Synthesis and Manufacturing
Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.
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.
December 02, 2016
Contract Services Update
Recipharm and Laccure AB signed a commercial collaboration for the manufacture and delivery of Laccure’s bacterial vaginosis treatment.
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.
November 30, 2016
Idifarma has acquired a Bosch GKF-702 capsule filling machine that can manufacture 3000 to 42,000 capsules per hour.
November 28, 2016
Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.
Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.
Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor
November 25, 2016
PCI is extending its cryogenic storage capabilities to its Rockford, Illinois operations to support storage and distribution of clinical trial materials.
November 17, 2016
The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.
November 10, 2016
Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.
November 09, 2016
Supply Chain Update
GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.
November 07, 2016
UPS entered into a definitive purchase agreement to acquire Marken, a provider of supply-chain solutions for the life-science industry.
November 04, 2016
The new facility will focus on formulation development, drug product analytical development, and quality control.