In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|September 11, 2015
AstraZeneca Buys Amgen's Biologics Manufacturing Facility
Author(s)Randi Hernandez
According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.
Advertisement
In preparation for a burgeoning biologics pipeline, AstraZeneca announced on Sept. 11, 2015 that it will purchase Amgen’s Boulder, CO manufacturing facility. According to Pam Cheng, executive vice-president, operations and information technology at AstraZeneca, the “facility will support the progression of biotech drug candidates” and will give AstraZeneca and its biologics research arm MedImmune “the flexibility and capacity” to meet the needs of its expanding biologics portfolio.
The Colorado plant is the latest development in AstraZeneca’s long-term plan to secure manufacturing capacity among various different locations. Biologics currently make up half of AstraZeneca’s current pipeline, according to the company, and many of its recent expansion efforts have been focused on supporting this pipeline. In May 2015, AstraZeneca expanded its overall biologics capacity through the $285-million purchase of a facility in Södertälje, Sweden. Prior to that, in November 2014, the company
The drugs that may be manufactured within the new plants could include brodalumab, AstraZeneca and Valeant’s investigational product for the treatment of psoriasis, and many of AstraZeneca’s investigational immune-oncology agents that it has in development, such as durvalumab (MEDI4736), an anti-PD-L1 monoclonal antibody for the treatment of patients with non-small cell lung cancer. AstraZeneca is partnering with Inovio Pharmaceuticals-a biotechnology company developing DNA-based immunotherapies-for the treatment of human papillomavirus (HPV) types 16 and 18. It also has a partnership with Kyowa Hakko Kirin to commercialize benralizumab for asthma and chronic obstructive pulmonary disease.
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
3
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
4
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
5