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

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..

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.

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.

Idifarma has acquired a Bosch GKF-702 capsule filling machine that can manufacture 3000 to 42,000 capsules per hour.

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

PCI is extending its cryogenic storage capabilities to its Rockford, Illinois operations to support storage and distribution of clinical trial materials.

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

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

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

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

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