BioPharm International

BioPharm International
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BioPharm International

 •  January 11

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies. Sartorius Stedim Biotech announced on Jan. 4, 2018 that it will the equipment supplier in the US for Abzena, a life sciences group that provides services and...

BioPharm International

 •  January 11

On Dec. 29, 2017, Athenex, a biopharmaceutical company, entered into an agreement with M+W, a German design, engineering, and construction company, for the design and construction of a new pharmaceutical manufacturing facility in Dunkirk, NY. The cost of the 320,000-ft2 facility is estimated between $205 million and $210 million. According to a...

BioPharm International

 •  January 8

Aptar’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste. The internal program, which was first introduced in 2013, is based on protocol established by the Zero Waste International Alliance Guidelines. Program...

BioPharm International

 •  January 5

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018. FDA Commissioner Scott Gottlieb, MD, released a statement on Jan. 4, 2018 giving an update on recovery efforts in Puerto Rico to mitigate the intravenous (IV) saline and amino acids for...

BioPharm International

 •  January 5

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval. FDA sent a warning letter, dated Jan. 3, 2018, to American CryoStem and its Chairman/CEO, John S. Arnone, for marketing an adipose-derived stem cell product without...

BioPharm International

 •  January 4

The company is voluntarily recalling product because of glass particles found in vials. On Jan. 3, 2018, AuroMedics Pharma LLC announced it was voluntarily recalling lot AFO l 17001-A of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial,...

BioPharm International

 •  January 4

On Jan. 4, 2018, contract manufacturer Wuxi Griffin announced the completion of a new 27,450-ft2 aseptic fill/finish facility in Wuxi, China. The facility is equipped with three filling suits and uses restricted access barrier systems and isolator production technology. According to the company, the facility is compliant with GMP standards and...

BioPharm International

 •  January 2

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance. PharMEDium Services, LLC announced on Dec. 27, 2017 that it was voluntarily recalling certain lots of product because of a lack of sterility assurance. The recall was issued after an FDA inspection of the company’s Memphis location led to...

BioPharm International

 •  December 28, 2017

AuroMedics Pharma has voluntarily recalled one lot of linezolid injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007, with the expiration date of August 2018, to the hospital level due to mold contamination, FDA announced on Dec. 22, 2017. The batch being recalled was distributed May 15–Aug. 14, 2017. The product was found to...

BioPharm International

 •  December 28, 2017

Mallinckrodt has agreed to acquire biopharmaceutical company Sucampo Pharmaceuticals for $18 per share, or a transaction value of approximately $1.2 billion. On Dec. 26, 2017, specialty pharmaceutical company Mallinckrodt announced that it has agreed to acquire Sucampo Pharmaceuticals, a biopharmaceutical company, in a deal valued at approximately...