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Category: Manufacturing


Manufacturing, Mergers and Acquisitions, Research and Development

AGC Biologics and BioConnection Team Up on Biopharma Drug Development and Manufacturing

May 24, 2024

Via: Biopharm International

On May 22, 2024, AGC Biologics and BioConnection, a contract manufacturing organization specializing in aseptic filling of vials and syringes for clinical and commercial production, announced that they have entered into a new strategic partnership. Under the agreement, the companies […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Addressing Performance, Scalability, and Regulatory Challenges to Accelerate Cell Therapy Manufacturing

May 16, 2024

Via: Biopharm International

To date, the FDA has approved 36 cell and gene therapy products. In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There […]


Manufacturing, Research and Development

Scientists reveal new method that could reduce waste from drug manufacturing

April 26, 2024

Via: Pharma Times

Scientists from the University of Edinburgh’s School of Chemistry have revealed a new sustainable method of manufacturing complex molecules that could reduce waste produced during drug production. The method published in Nature Chemistry could help to prevent severe side effects […]


Manufacturing, Research and Development

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

April 10, 2024

Via: Biopharma Dive

The enrollment pause could affect at least one ongoing Phase 3 study of Novartis’ pill, which is approved for use in advanced and metastatic disease. That clearance is limited to people whose tumor can be treated with hormone drugs but […]


Manufacturing, Research and Development

Installation of Cytiva’s Aseptic Filling Workcell Aimed at Raising White Raven’s Manufacturing Efficiency

March 21, 2024

Via: Biopharm International

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva’s SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s […]


Manufacturing, Research and Development

Advanced technologies in unlocking the future of drug manufacturing

March 11, 2024

Via: Biopharma Dive

As the manufacturing landscape changes, it opens the door to pursuing hybrid opportunities that push the boundaries of technological advancement in the field. As an Industry Leader in two key domains: flow chemistry and biocatalysis, Asymchem has developed an innovative […]


Manufacturing, Research and Development

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

February 7, 2024

Via: Biopharm International

On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in notifying the agency about changes in […]


Manufacturing, Research and Development

Data infrastructure excellence changing the shape of biopharma manufacturing

November 20, 2023

Via: Biopharma Dive

In biopharma manufacturing, there is a fine line between being data rich and information poor. Sites are filled with disparate systems, increasing the potential for siloed data. But since data is so key, biopharma companies must find better ways to […]


Manufacturing, Research and Development

Accelerating Lentivirus Manufacturing: Choosing the Right Plasmid Manufacturing Platform

November 17, 2023

Via: Biopharm International

Plasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]


Manufacturing, Research and Development

Forbion-backed biotech raises $138M to develop ALS drug

November 14, 2023

Via: Biopharma Dive

Netherlands-based biotechnology company VectorY Therapeutics has raised 129 million euros, or $138 million, to fund development of brain disease drugs. The Series A financing, announced Monday, was co-led by venture capital firm Forbion and European investor EQT Life Sciences, alongside […]


Manufacturing, Research and Development

Aragen to Establish $30 Million Biomanufacturing Facility in India

November 2, 2023

Via: Biopharm International

On Oct. 30, 2023, Aragen, a contract research development and manufacturing organization (CRDMO), announced that it was setting up a new biologics manufacturing facility in Bangalore, India as part of a $30 million investment. The new 160,000 m2 facility will […]


Manufacturing, Research and Development

Innovations and Trends in Aseptic Manufacturing Processes

September 29, 2023

Via: Biopharm International

In 2022, the number of newly approved biologic drugs outpaced that of small molecules for the first time (1). Notably, almost a third of the new approvals comprised novel modalities, such as cell and gene therapies, antibody–drug conjugates, and bispecific […]


Manufacturing, Research and Development

Optimizing Fermentation Processes for Biologics Manufacturing

September 29, 2023

Via: Biopharm International

The recent resurgence in microbial fermentation for biologics production can be attributed to many factors. Advances in biochemistry and a growing understanding of when glycosylation is not needed, improved capabilities for modification of naked proteins, the emergence of new protein […]


Manufacturing, Research and Development

ML and AI Implementation Insights for Bio/Pharma Manufacturing

September 29, 2023

Via: Biopharm International

This survey conducted by the authors examined factors of Roger’s diffusion of innovation theory related to adopting machine learning (ML) and artificial intelligence (AI) in the bio/pharmaceutical manufacturing industry. The sample included industry leaders and bio/pharmaceutical professionals with experience in […]


Manufacturing, Research and Development

CPHI Annual Report Predicts AI Transformation of All Drug Development Processes by 2026

September 15, 2023

Via: Biopharm International

A recent publishing of the first part of the CPHI Annual Report predicts substantial progress ahead for artificial intelligence (AI)’s use in pharma, despite the uproar surrounding ChatGPT and other AI programs. According to a press release, the implications go […]


FDA, Manufacturing, Regulations, Research and Development

FDA boosts collaboration with manufacturers to overcome ongoing cancer drug shortages

September 15, 2023

Via: PMLiVE

The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their […]


Manufacturing, Research and Development

Drug Digest: Accelerating Biopharma Development and Manufacturing through CDMOs and CGT

August 9, 2023

Via: Biopharm International

The biopharmaceutical industry has seen a lot of change in recent years, between new collaborations with supplier and contract development and manufacturing organizations (CDMOs) and accelerated drug delivery times. According to recent research, biopharmaceutical figures are already using digital and […]


Manufacturing, Research and Development

Lonza and Vertex work Co-invest in a New Production Plant

June 30, 2023

Via: Contract Pharma

Vertex Pharmaceuticals and Lonza are partnering in the production of a new facility. Both companies are working together to manufacture and support the production of Vertex’s experimental cell therapy VX-880 for Type 1 diabetes and a second candidate VX-264. The […]


Manufacturing, Research and Development

Andelyn Biosciences Opens New CGT Manufacturing Headquarters

June 22, 2023

Via: Biopharm International

On June 22, 2023, Andelyn Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization, announced the opening of its newly constructed manufacturing headquarters in Columbus, Ohio. According to a company press release, the 180,000-ft2 facility is intended […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Mendus and NorthXBiologics Enter Cell Therapy Manufacturing Alliance

June 15, 2023

Via: Biopharm International

Mendus, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, and NorthX Biologics, a contract development and manufacturing organization that serves as the National Swedish Innovation Hub for the good manufacturing practice (GMP) manufacture of biologics used in vaccines, gene […]