APIs and Excipients

MHRA Approves Johnson Matthey’s Annan, UK, Site for GMP Manufacturing

September 20, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

The certification follows a successful inspection by the MHRA, with no critical or major observations. The site is now ready to start production.

Saneca Pharma Invests in Small-Scale API Capabilities

September 12, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.

The Search for a Greener Fluorination Reaction

September 02, 2016

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.

Optimizing API Manufacturing

September 01, 2016

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

Data Integrity Emerges as an Excipients Issue

September 01, 2016

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

Sartorius Stedim Biotech Introduces Fully Integrated Upstream Platform

September 01, 2016

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

Fuji Health Changes Name to Fuji Chemical Industries USA, Inc.

September 01, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

API and drug product manufacturer changes name to align with parent company.

Dalton Expands Canadian Manufacturing Facility

August 30, 2016

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Alcami Expands US API Capacity

August 18, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Irvine Scientific Launches BalanCD HEK293 System for Large-Scale Expression of Proteins and Viral Vectors

August 15, 2016

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.