This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|Articles|September 6, 2018
AGC Biologics Expands Capacity at Denmark Facility
Author(s)BioPharm International Editors
The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.
Advertisement
AGC Biologics, a contract development and manufacturing organization specializing in the clinical and commercial manufacture of therapeutic proteins, announced on Aug. 22, 2018 that the company is increasing manufacturing capacity at its Copenhagen, Denmark facility as part of its global expansion strategy.
The Copenhagen facility will add a single-use bioreactor 6Pack suite consisting of six 2000-L production bioreactors and a 2000-L seed train. The six bioreactors will be run in single unit operations or in groups-simultaneously, sequentially, or staggered-to meet each client's specific production needs. According to the company, the addition of this proprietary bioreactor configuration will enable more flexible, innovative, and customized cGMP production capabilities, offering scales from 2000 L to 12000 L within a single run.
The expansion also includes additional capabilities for harvesting, purification, buffer, and media production that will support the processing of different therapeutic proteins, including high antibody titer processes. The company reports that the new suites are scheduled to be online in November 2018 and are expected to support the manufacturing of several commercial products.
Source:
Advertisement
Related to this article
Bimekizumab-bkzx (Bimzelx) produced ACR50 joint responses in 54.9% of psoriatic arthritis patients at week 24 vs 43.8% with risankizumab.
VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.
Matt Trupo, Richard Jaenisch, and Brian Drapeau explore how AI advances biological insights, drug-target discovery, and supply chains.
As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.
Aldevron and IDT added PE Ultra prime editor mRNA and 6 ABE8e base editor mRNAs to help researchers edit DNA without double-strand breaks.
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.
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.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
4
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
5