Tag: GMP Standards

Sartorius became the supplier of ABL Europe

Sartorius Stedim Biotech S.A. (SSB), a leading international technology partner of the biopharmaceutical industry, has been selected by ABL Europe as its primary supplier of single-use systems.

Pre-commissioning activities were completed at Aspectus Pharma facility

The production facility prepares to undergo a GMP audit and obtain licenses for full-cycle manufacturing of modern, high-quality and safe drugs.

iBio expanded its CDMO capabilities for manufacturing of Fc Fusion Proteins

IBio announced the expansion of its CDMO capabilities and services to include the development and cGMP manufacturing of Fc fusion proteins for therapeutic pharmaceutical applications.

Hookipa Biotech entered in a GMP manufacturing collaboration with ABL Europe

test tubes
Hookipa Biotech AG, a clinical stage biotech company, and ABL Europe SAS, an ABL Inc. company providing viral vector GMP contract manufacturing services, have entered in a manufacturing collaboration.

AXIM Biotech uses cGMP methods for its production of cannabinoid APIs

medicinal cannabis
AXIM Biotechnologies announced the successful execution of proprietary cGMP methods to extract and microencapsulate cannabinoid molecules for a variety of pharmaceutical delivery formats from cGMP-produced medicinal cannabis.

Georgia implements GMP/GDP standards and establishes a national inspectorate

The Georgian Ministry of Labor, Health and Social Affairs began to introduce new standards aimed at improving the quality control of imported medicines and drugs manufactured in Georgia.

CARBOGEN AMCIS manufacturing facility passed a quality inspection

Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient manufacturing company, announced that its Vionnaz site has successfully completed a Swissmedic inspection

LakePharma launches GMP biomanufacturing center

LakePharma, Inc., the leading US-based biologics company specializing in antibody and protein engineering, cell line development and protein production, announced the launch of the LakePharma MicroBiomanufacturing (GMP) Center

EAEU common market of medicines is based on European standards

In May 2017, the markets of medicinal products and medical devices in the five member states of the Eurasian Economic Union (EAEU) received the legal right to start operating as a common economic space

Wuxi Griffin will give effect to Western GMP standards in its operation

pharmaceutical manufacturing
The new company, Wuxi Griffin, is to operate as an international contract manufacturer of sterile fill pharmaceuticals. It is a western managed joint venture between Sweden and China

GenCure launches BioManufacturing Centre for production of stem cells

stem cells
GenCure opened the first phase of a new biomanufacturing center designed to address a critical roadblock slowing the advancement of cellular therapies

MedPharm verified its cGMP and GLP certification in 2017

MedPharm has announced that after recent successful MHRA inspections, it has renewed its cGMP and GLP accreditations.

PhEB: Pre-authorization Issues of Placing Pharmaceuticals on the Market

This is a Special Video Series describes general regulatory framework and main pre-authorization issues, including GMP certification, non-clinical, and clinical testing

New Bedrocan production facility manufactures in accordance with GMP

medicinal cannabis
Bedrocan, the world’s most experienced producer of legal medicinal cannabis, meets international pharmaceutical quality and safety requirements

WuXi Biologics put its new cGMP manufacturing facility into service

WuXi Biologicsannounced that its cGMP biologics manufacturing facility in Wuxi city with 30000 L bioreactor capacity entered into full operation

CDMO Brammer Bio launches its renovated cGMP manufacturing site

Brammer Bio announced the completion of renovations and launch of its late-stage clinical capacity and commercial-ready cGMP manufacturing site