Pharmaceutical Online

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Pharmaceutical Online

 •  December 17

Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered such as the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical...

Pharmaceutical Online

 •  December 14

Preparing For Brexit: Advice From The EMA By Yulia Privolnev, Decision Resources Group On December 4, the UK’s Business, Energy and Industrial Strategy (BEIS) parliamentary committee announced it was investigating the implications of Brexit for the UK’s pharmaceutical market, amidst fears Brexit will threaten "the cost of medicines, investment in...

Pharmaceutical Online

 •  December 13

In recent years, single vendor contract development and manufacturing organizations (CDMOs) have presented a compelling new approach to address inefficient multi-vendor development and manufacturing approaches. There are several efficiencies promised by a single-source CDMO including running multiple manufacturing steps in tandem, eliminating the...

Pharmaceutical Online

 •  December 11

By Andrew Walsh; Thomas Altmann; Alfredo Canhoto, Ph.D.; Ester Lovsin Barle, Ph.D.; David G. Dolan, Ph.D.; Andreas Flueckiger, M.D.; Igor Gorsky; Robert Kowal; Mariann Neverovitch; Mohammad Ovais; Osamu Shirokizawa; and Kelly Waldron Part of the Cleaning Validation For the 21st Century series Two previous articles discussed how the acceptable daily...

Pharmaceutical Online

 •  December 7

Terry Ward Nephron Pharmaceuticals Corporation, a manufacturer of sterile inhalation and 503B outsourcing medications, today announced a $12.5M expansion to add 36,000 square feet of manufacturing space. The new investment is expected to create 125 new jobs by June. “The improvement of the facility will help us meet our commitment to solve the...

Pharmaceutical Online

 •  December 7

Industry Insights Why Early Investment In A Scalable Manufacturing Process Is Critical Article | By Enrico Corona and Jonathan Sutch, Patheon The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30 percent of compounds successfully transition from Phase 2 to Phase 3. How To...

Pharmaceutical Online

 •  December 7

It has long been a goal of regulators in the United States and Europe to reach a mutual recognition agreement under which the U.S. FDA and its regulatory counterparts in the European Union could recognize and rely on each other’s GMP inspections of pharmaceutical facilities. Through such an agreement, regulators could avoid duplicative inspections,...

Pharmaceutical Online

 •  December 7

Contact The Supplier SIMCA® and SIMCA®-online software updates in the Umetrics™ Suite help manufacturing industries make better business decisions and optimize process control Goettingen, Germany / Malmö, Sweden – December 07, 2017: Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has introduced a...

Pharmaceutical Online

 •  December 6

One (1) used Quadro Comil mounted in isolator, model U10, stainless-steel construction, missing beater and screen, direct coupled 20 hp, 230/460 volt xp motor with VFD controller mounted in xp panel, unit mounted in Carlisle Life Science isolator, stainless-steel construction, single sided with five (5) glove ports, approximately 60" long x 22"...

Pharmaceutical Online

 •  December 4

PharmaForce Inc., a privately held pharmaceutical R&D and manufacturing company, will expand two of its existing facilities in the Columbus Region, investing approximately $145M and creating 80 new jobs. Construction and remodeling will commence in 2018, with hiring for packaging, mechanical, sterile, quality assurance and validation beginning in...