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good manufacturing practice (GMP)

Here, Jim Morris from NSF International, summarises the benefits of an excipient GMP certification programme (ECP) both from the point of view of the excipient manufacturer and the excipient customer. Read more

Opinion

ProBioGen (service and technology provider for complex therapeutic glycoproteins) and Pionyr Immunotherapeutics have initiated a second immune-oncology contract development and manufacturing project. Read more

News

The US Food and Drug Administration (FDA) has issued warnings to two Chinese drug manufacturers for violations of good manufacturing practice (GMP), according to a post from the Regulatory Affairs Professionals Society (RAPS). Read more

News

In this article, Anneke Evers, senior director Sales & Market Support DPTE Sterile Transfer, Getinge, discusses sterile transfer systems, industry standards and what the next steps to evolve these systems need to be. Read more

Opinion

In this article, Stephen Morley from Steelco, looks at the new developments in stopper processing equipment. Read more

Opinion

A £2 million funding round has been completed that will enable drug delivery company, Bio-Images Drug Delivery (BDD) to scale up its business to allow GMP manufacture of its OralogiK precision timed drug delivery system — ‘pill within a pill’. Read more

Technology

Micro-Sphere, a Swiss-based CDMO, has successfully completed the Swissmedic inspection of its expanded facility, allowing for the renewal of its GMP approved status and increased manufacturing capacity Read more

News

Raumedic, manufacturer of pharmaceutical packaging solutions, has received ISO quality standard certification for its primary packaging options. Read more

News

Biotechnology company, Pherecydes Pharma, has raised €8.7 million in a Series B round of funding, which it plans to use to support the production of phages for compassionate use in accordance with good manufacturing practuces (GMP). Read more

News

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more... Read more

Opinion

Batavia Biosciences is expanding its viral vector process development facilities in the US and its cleanroom facilities in the Netherlands to meet increasing market demand. Read more

News

An award worth £12 million, from the government’s investment in healthcare and life sciences, will be used to expand the current size and capability of the Cell and Gene Therapy Catapult large-scale GMP Manufacturing Centre Read more

News

Contract development and manufacturing organisation (CDMO) that specialises in spray drying and capsule filling services, Micro-Sphere, is investing €19 million to expand its GMP manufacturing capabilities at its Swiss facility. Read more

News

CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and API manufacturing company, has successfully completed Swissmedic inspections at three of its sites, resulting in the renewal of GMP certificates. Read more

News

Global provider of drug development and delivery solutions to pharma and biopharma sectors, Patheon, has announced the completion of its expansion project at its Greenville site in North Carolina. Read more

News

It has been announced that Chemische Fabrik Budenheim site in Budenheim, Germany, has recently been awarded an EXCiPACT GMP/GDP certificate from SGS — one of EXCiPACT’s internationally recognised certification bodies. Read more

News

A collaboration to bring the first advanced sleep cannabis formulation has been announced at the Israel-based cannabis conference, CannaTech. Read more

News

Medicinal cannabis producer, Bedrocan, has become the first company of its kind to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards. Read more

News

F-star and CMC Biologics are collaborating for Good Manufacturing Practice (GMP) of the FS118 immune-oncology programme, ahead of future clinical studies Read more

News

Ashland, a specialty chemicals supplier, has been awarded an Excipact Good Manufacturing Practice (GMP) certificate for its pharmaceutical excipients Read more

News