Manufacturing

Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price.

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

Under this agreement, Acuitas Therapeutics’ LNP technology platform will be transferred to BIOVECTRA for use in manufacturing mRNA-based therapies.

Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.

Cambrex has completed the expansion of its North Carolina facility, doubling its manufacturing capacity.

Webinar Date/Time: Thu, Nov 2, 2023 2:00 PM EDT

Webinar Date/Time: Thu, Oct 26, 2023 11:00 AM EDT

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

Biosynth has further strengthened its peptide division with the acquisition of Pepceuticals.

Webinar Date/Time: Mon, Oct 30, 2023 11:00 AM EDT

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Webinar Date/Time: Mon, Oct 23, 2023 11:00 AM EDT

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Twin-screw granulation process insight is growing as researchers employ new analytical technologies and investigate new ways to use the equipment.