Manufacturing

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.

The ROSS Model CDA-200 is fitted with multiple agitators for semi-continuous operation.

Sphere Fluidics’ Cyto-Mine is an automated cell line platform that is designed to enable screening of up to 40 million cells over the course of several hours.

Eurofins Genomics Blue Heron IVT mRNA synthesis service is designed to provide researchers a customizable solution.

Thermo Fisher Scientific’s Gibco OncePro Tumoroid Culture Medium Kit was specifically developed for the expansion of patient-derived tumoroids from multiple cancer indications.

Environmental monitoring data can help keep sterile environments sterile.

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.

The goal for Upperton is to become fully operational by Q4 of 2023 for development and non-GMP manufacturing and a target start of GMP operations in January 2024.

Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, discusses the history and ongoing development of both protein- and mRNA-based vaccines.

Webinar Date/Time: Thursday, August 24th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.

Parenteral packaging and handling advancements receive awards.

In this episode, Sergey Vlasenko from Agilent chats about bio/pharmaceutical manufacturing trends, with a particular focus on oligonucleotides.

Webinar Date/Time: Tue, Aug 8, 2023 11:00 AM EDT

Kelly Doering, senior director at Aspen Technology, unpacks various strategies for holistic data integration into pharma operations.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.