Manufacturing

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.

Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

The market potential of nucleic acid-based therapies have been pushed into the spotlight following the success of the COVID-19 vaccines.

CPC presents a green alternative to chromatography that supports sustainable operations.

Webinar Date/Time: Thu, Jun 1, 2023 11:00 AM EDT

The development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.

It is crucial to examine the context in which single-use waste is viewed.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Webinar Date/Time: Tue, May 16, 2023 11:00 AM EDT

Gregor Kawaletz, head of Oral Solid Dose Business Unit at Recipharm, discusses the immediate future of oral biologics

Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.

The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.

Monil Malhotra, vice-president of Industrial Software at Emerson, discusses the growing demand for software solutions in the pharma industry.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

Michalle Adkins, director of Life Sciences Consulting at Emerson, discusses the structure of manufacturing organizations and how novel technologies may play a role in operations.

Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.

The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

Lives are saved when time from vein to vein decreases.

Claudio Fayad, VP of Technology, Process Systems, and Solutions discusses the intersection of automation and data security in the pharma industry.

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

Nicole Lewis, PVP Program Manager at Boston Children's Hospital, discusses the science behind precision vaccines, a form of personalized vaccines.

Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.

Webinar Date/Time: Tue, May 2, 2023 11:00 AM EDT

Nathan Pettus, president of Process Systems and Solutions at Emerson, discusses how automation is impacting recent sustainability technologies and solutions.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.

The COVID-19 vaccines opened the door to powerful market potential for other nucleic acid-based therapies.