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Category: Manufacturing


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On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in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


Manufacturing, Research and Development

Nexcella Begins Production of CAR-T Cell Therapy Engineering Batches at US Manufacturing Site

May 31, 2023

Via: Biopharm International

Nexcella, a subsidiary of US-based Immix Biopharma and a clinical-stage biopharmaceutical company, announced on May 26, 2023 that it has begun producing engineering batches of NXC-201, its lead candidate and a chimeric antigen receptor T cell (CAR-T) therapy, at its […]


Manufacturing, Research and Development

Scaling Manufacturing Processes Using Single-Use Technologies

May 30, 2023

Via: Biopharm International

Since biological drugs first became available, their demand has been increasing—with the biologic market being valued at approximately US$302.63 billion in 2020 and expecting to reach US$509.23 billion by 2026 at a compound annual growth rate of 9.06% (1). With […]


Manufacturing, Research and Development

TriLink BioTechnologies to Expand Manufacturing Capabilities

May 24, 2023

Via: Biopharm International

TriLink BioTechnologies announced the expansion of its messenger RNA (mRNA) manufacturing capabilities on May 24, 2023. The new construction of the current good manufacturing practice (CGMP)-grade facility will help the company with its mission to advance the field as more […]


Manufacturing, Research and Development

Yposkesi Launches LentiSure Lentiviral Vector Production Platform

April 28, 2023

Via: Contract Pharma

Yposkesi, SK pharmteco’s clinical and commercial viral vector manufacturing arm for cell and gene therapies, launched LentiSure, an optimized Lentiviral (LV) Vector manufacturing platform for increasing lentivirus production efficiency and robustness. Lentivirus or LV vectors are used to produce cell-based […]


Manufacturing, Research and Development

Bristol Myers boosts cell therapy production with Novartis plant

April 26, 2023

Via: Biopharma Dive

Cell therapies are powerful weapons for treating some cancers, but the manufacturing required is complex and time-consuming. Bristol Myers has previously had difficulties producing enough of its two CAR-T cancer therapies to keep up with demand. Bristol Myers won approval […]


Manufacturing, Research and Development

Lipella Pharmaceuticals, Cook MyoSite Enter Manufacturing Agreement

April 17, 2023

Via: Contract Pharma

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. to facilitate chemistry, manufacturing, and control (CMC) documentation for Lipella’s drug candidate LP-10 (liposomal tacrolimus), […]