This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|Articles|September 1, 2015
Serialization Software Helps Companies Stay Compliant
Author(s)BioPharm International Editors
Adents’ Pharma Suite serialization software features track-and-trace capabilities.
Advertisement
Adents’ Pharma Suite serialization software, developed in compliance with GMP and 21 Code of Federal Regulations (CFR) Part 11 regulations and following GAMP5 guidelines, features track-and-trace capabilities,
including generation of unique barcodes and importation of serial numbers, affiliations management for origin identification (bundle, pallet, etc.), and distribution of various types of serialized code.
The software is compatible with both information systems (e.g., enterprise resource planning, manufacturing execution systems) and existing production and packaging equipment. Pharma Suite is designed to address both current and emerging regulations.
The software includes the Adents Pharma Exchange gateway to transit serialization data, the Adents Pharma Supervisor to manage and distribute serialized codes, and the Adents Pilot to direct printing and vision systems and manage communication with line equipment.
Adents
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
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