Pharmaceutical Outsourcing

Pharmaceutical Outsourcing
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Pharmaceutical Outsourcing

 •  September 18

Alcami announced its new analytical testing facility in the Cortex Innovation Community, a 200-acre innovation hub and technology district. The facility will be Alcami’s new Center of Excellence for its advanced analytical testing operations. Alcami’s centrally located new St. Louis campus is easily accessible for both domestic and international...

Pharmaceutical Outsourcing

 •  September 18

Brammer Bio announced completion of its clinical capacity expansion in Alachua, Florida. This doubles Brammer's early phase manufacturing capacity to support clients' Phase I/II cell and gene therapy clinical trials. Brammer's Florida site incorporates equipment and facility design concepts that are setting the standard for early clinical supply,...

Pharmaceutical Outsourcing

 •  September 18

PuraCap announced the US Food and Drug Administration (FDA) has completed a successful general inspection of its affiliated soft gelatin capsule manufacturing facility located in Wuhan, Hubei Province China. In addition, a pending ANDA was also recommended for approval as a result of this successful inspection. The inspection confirmed that the...

Pharmaceutical Outsourcing

 •  September 15

PCI Pharma Services announced an investment in an expansion of onsite Cold Chain storage at the company’s Philadelphia site. An additional 500 pallet spaces have been added, increasing the onsite 2-8°C refrigerated storage at their commercial packaging center of excellence to more than 1,300 pallets. The 450,000 square foot site features contract...

Pharmaceutical Outsourcing

 •  September 13

By Michael Kopcha, Ph.D., R.Ph., FDA’s Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research Today, a new and exciting technology – continuous manufacturing (CM) – can truly transform the drug manufacturing process so that it is more reliable and efficient. We discussed in a previous blog how CM enables a much faster...

Pharmaceutical Outsourcing

 •  September 13

Vanrx Pharmasystems is introducing the Microcell Vial Filler, a new gloveless robotic isolator for aseptic filling. The Microcell is focused on clinical trial production and development of sterile injectable biopharmaceuticals, cell therapies and personalized medicines. The Microcell provides a cost effective and simple path for companies to add...

Pharmaceutical Outsourcing

 •  September 12

Kaneka Eurogentec announced its board has approved the construction of a new state of-the-art GMP facility adjacent to its current facility and equipped with a 2200 L fermenter. The expansion will allow for the large scale production of biopharmaceuticals including recombinant proteins, antibody fragments and plasmid DNA. The multi-product facility...

Pharmaceutical Outsourcing

 •  September 8

Therapure Biopharma announced a joint venture between 3SBio and CPE Funds has entered into an agreement to acquire Therapure’s contract development and manufacturing (CDMO) business and certain rights to plasma products and technology for the Chinese market for US$290 million, subject to certain adjustments. The CDMO business will continue to...

Pharmaceutical Outsourcing

 •  September 7

According to new industry research more than half (54%) of industry professionals believe that the cost of implementing serialization is the greatest hurdle to compliance. The research, conducted by serialization software provider, SEA Vision and life sciences technology firm, Zenith Technologies, highlighted that the substantial investment...

Pharmaceutical Outsourcing

 •  September 5

Catalent Pharma Solutions has entered into an exclusive agreement with US WorldMeds for the commercial manufacture of lofexidine, an investigational drug under development to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. US WorldMeds has the rights to commercialize lofexidine in...