Almac Pharma Services has successfully supported the packaging and rapid launch of Provention Bio Inc’s product, TZIELD (teplizumab-mzwv) into the U.S. market.
 
TZIELD was recently approved by the U.S. FDA for intravenous use as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening.
 
T1D is an autoimmune disease that occurs when the immune system attacks and destroys the cells that make insulin. People with Stage 3 T1D have increased glucose levels, eventually requiring insulin shots and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, T1D is usually diagnosed in children and young adults.
 
The Almac Pharma Services’ Pennsylvania-based team began its partnership with Provention Bio, Inc. to support the packaging of the TZIELD product for commercial supply in 2020. 
 
“At Provention, we look to our manufacturing and operational partners for their strong industry expertise, infrastructure and compliance to regulatory standards to help execute a successful commercial launch,” noted Christina Yi, Chief Operations Officer at Provention Bio. “That’s why we partnered with Almac – our operational partnership supports TZIELD reaching patients across the US and helps us accelerate the depth and breadth of its launch.”
 
Harry Lindenmuth, Audubon Site Director, Almac Pharma Services said, “We are pleased to have supported the launch of Provention Bio, Inc.’s first biologic treatment. Our team is delighted to have played a role in packaging this key advancement in delaying the onset of stage 3 type 1 diabetes.  Through our relationship with Provention Bio, Inc., the teams worked diligently to develop a plan and implement the most appropriate robust and timely processes, protecting the integrity of TZIELD whilst ensuring it was delivered shortly after FDA approval. Many congratulations to our partners at Provention Bio, Inc. on the development of this treatment.”