News

Idifarma, a Spanish contract development and manufacturing organization (CDMO) that specialises in niche and highly potent products, confirmed on Oct. 1, 2018 that its good manufacturing practice (GMP) spray drying technology for highly potent drugs is now operational.

Rentschler Fill Solutions received a certificate of GMP compliance from the Austrian Agency for Health and Food Safety for its new aseptic fill/finish facility.

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

Kangstem Biotech has selected Orgenesis subsidiary, MaSTherCell, as its contract manufacturing partner for the European clinical trial of Furestem-AD.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Researchers who are younger than 35 years with an advanced degree and working within Europe will be able to apply for the award.

The divestiture of the European generic-drug business of Sanofi-Zentiva-to Advent International has been completed.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

Mettler Toledo’s XSR Analytical Balances help simplify laboratory workflows and enable convenient and ergonomic balance operation while delivering high-weighing accuracy.

Romaco Siebler and Huhtamaki will premiere a push-through strip packaging for pharmaceuticals at CPhI WorldWide 2018.

As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.

This pharma insight briefing from Agilent Technologies will cover the application of Raman and infrared spectroscopy for pharmaceutical quality control (QC).

The companies collaborated to launch a new cell-based profiling service for biochemical assay.

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

New software tools by Tecan, a provider of automated laboratory instruments and solutions, complement each other to enhance process monitoring of its liquid-handling platforms.

CPhI releases the bio trends portion of its annual report, which predicts an increase in bioconjucation expertise and biopharma productivity over the next five years.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

Vetter chose a winner from four teams that worked for three months to develop ideas for applying digital technology to injectable pharmaceuticals.

The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

CDER director plans to start implementation of new review practices by the end of 2018.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The World Packaging Organization will present a keynote session at CPhI discussing trends affecting pharmaceutical packaging, including user-friendly design.

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

The company plans to lay off approximately 400 employees to support the restructuring of its R&D organization.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

Nanjing-based PharmaBlock Sciences acquired a GMP-compliant manufacturing facility in Shangyu, China from Porton Pharma Solutions.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.