Manufacturing - Clinical Research Informer

Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Bio Pharma Dive

AUGUST 21, 2024

Company executives had previously warned investors that a delay was likely due to issues at a facility run by third-party manufacturer.

Manufacturing

Manufacturing Drugs

Biotechnology Equipment Manufacturers, Companies and Suppliers for the Pharmaceutical Industry

Pharmaceutical Technology

SEPTEMBER 25, 2024

Discover the leading Biotechnology Equipment Manufacturers, Companies and Suppliers. Download the free Buyer's Guide today for full details.

Manufacturing

Gene therapy biotech Jaguar spins out manufacturing company

Bio Pharma Dive

JANUARY 18, 2024

Called Advanced Medicine Partners, the new company will offer specialized cell and gene therapy manufacturing services to biotech and pharma clients.

Gene Therapy

Gene Therapy Manufacturing Gene Medicine

German CDMO outlays $980m on GLP-1 manufacturing expansion

Pharmaceutical Technology

JULY 16, 2024

As the EU anticipates GLP-1RA shortages throughout 2024, Corden Pharma has pledged $980m to increase manufacturing capacity.

Manufacturing

Making the Case for Case Management for Cell and Gene Therapies

A dedicated Case Manager provides end-to-end supply chain management and 24/7 oversight and support to help ensure the seamless manufacturing and distribution of each therapy dose to every patient.

Gene Therapy

Rocket gene therapy rejected by FDA over manufacturing

Bio Pharma Dive

JUNE 28, 2024

The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

Gene Therapy

Gene Therapy Manufacturing Gene

Eli Lilly to invest $1.8bn in manufacturing capacity in Ireland

Pharmaceutical Technology

SEPTEMBER 13, 2024

Lilly has announced a significant expansion of its manufacturing presence in Ireland, with a $1bn investment earmarked for its Limerick site.

Manufacturing

PHC uses LiCellGrow prototype for cell and gene therapy manufacture

Pharmaceutical Technology

SEPTEMBER 2, 2024

PHC Corporation has introduced a prototype of LiCellGrow, a cell expansion system designed to manufacture cell and gene therapy products.

Gene Therapy

Gene Therapy Manufacturing Gene Production

Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

MARCH 6, 2023

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. It will also establish cGMP manufacturing of a drug product which will be utilised in future clinical trials.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Production

Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.

Clinical Supply

Bayer expands German manufacturing facilities to fulfill supply demand

Pharmaceutical Technology

NOVEMBER 24, 2023

Bayer announced the launch of a Berlin, Germany-based manufacturing facility to meet future demands from the US, China and Europe.

Manufacturing

California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

JULY 15, 2022

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

Insulin

Insulin Manufacturing Contract Manufacturing Production

Chime looks to expand manufacturing capacity and establish European presence

Pharmaceutical Technology

AUGUST 6, 2024

The China-headquartered CDMO is planning to scale its manufacturing operations, expand its presence in APAC, and set up a Swiss subsidiary.

Manufacturing

AstraZeneca may pull plug on UK vaccine manufacturing plans

Pharmaceutical Technology

AUGUST 23, 2024

AstraZeneca may relocate its vaccine manufacturing plans from the UK to US as the finance minister discusses financing cuts.

Manufacturing

Manufacturing Vaccination Vaccine

Lilly ramps up Irish manufacturing investment by $1bn

pharmaphorum

SEPTEMBER 13, 2024

Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above (..)

Manufacturing

Robotics: Transforming cell and gene therapy manufacturing

Pharmaceutical Technology

AUGUST 16, 2023

Several companies are developing robotics to automate cell and gene therapy manufacturing, but some challenges persist.

Gene Therapy

Gene Therapy Manufacturing Gene Development

Medical packaging companies in pharmaceutical contract manufacturing

Pharmaceutical Technology

JUNE 25, 2024

Discover the critical factors in choosing medical packaging companies for pharmaceutical contract manufacturing. Ensure quality with our guide.

Contract Manufacturing

Contract Manufacturing Packaging Packaging Manufacturing

Contract manufacturer PCI pumps $365M+ into US, EU packaging projects

Fierce Pharma

SEPTEMBER 24, 2024

Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic. | Altogether, PCI’s manufacturing projects represent an investment of more than $365 million.

Contract Manufacturing

Contract Manufacturing Packaging Packaging Manufacturing

FDA rejects Abeona cell therapy, asks for more manufacturing data

Bio Pharma Dive

APRIL 23, 2024

The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.

Manufacturing

Manufacturing Gene Therapy Gene Development

Centre forms 5-member panel to examine manufacturing of nutraceuticals within drug production facility

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 24, 2024

Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.

Manufacturing

Manufacturing Production Drugs Clinical Trials

Novo obesity drug sales lag as manufacturing problems persist

Bio Pharma Dive

NOVEMBER 2, 2022

Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro.

Manufacturing

Manufacturing Sales Medicine Drugs

AI startup Leucine raises $7m for drug manufacturing digital twin platform

Pharmaceutical Technology

OCTOBER 17, 2023

As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.

Manufacturing

Manufacturing Compliance Drugs

Pharmaceutical clean room manufacturing, flooring and design

Pharmaceutical Technology

MAY 22, 2024

Discover the key factors and latest advancements in pharmaceutical clean room manufacturing, flooring, and design to ensure full regulatory compliance.

Manufacturing

Manufacturing Compliance

Pharmaceutical Lyophilization Manufacturers, Companies and Solutions

Pharmaceutical Technology

MAY 20, 2024

Discover what to look for in pharmaceutical lyophilization manufacturers and stay ahead with the latest in freeze-drying technology.

Manufacturing

FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

Pharmaceutical Technology

AUGUST 21, 2024

The issue at a third-party manufacturer has been resolved, with an FDA re-inspection now planned.

Manufacturing

Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Pharmaceutical Technology

JULY 6, 2023

Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.

Manufacturing

Manufacturing Vaccination Vaccine

Leading peptide manufacturers: Custom solutions and quality assurance

Pharmaceutical Technology

MAY 29, 2024

Discover leading peptide manufacturers offering bespoke solutions and stringent quality assurance. Ensure your biotech projects succeed with our expert guide.

Manufacturing

Optimizing API Manufacturing: Lessons from the Industry

Drug Patent Watch

SEPTEMBER 4, 2024

Optimizing API manufacturing is crucial for ensuring the consistent production of high-quality APIs. The pharmaceutical industry has learned valuable lessons from various strategies and technologies that have significantly improved the efficiency, precision, and sustainability of API manufacturing processes.

Manufacturing

Manufacturing Production

Moderna to set up new mRNA manufacturing facility in Kenya

Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK.

Manufacturing

Manufacturing Gene Therapy Gene Genetics

Oral solid dosage manufacturing companies, equipment and market

Pharmaceutical Technology

MAY 10, 2024

Discover key insights into the selection of oral solid dosage manufacturing companies and equipment. Learn about the latest technological advancements in the oral solid dosage industry and market.

Manufacturing

Manufacturing Marketing

Parenteral Solutions in Contract Manufacturing for the Pharmaceutical Industry

Pharmaceutical Technology

MAY 19, 2024

Discover what industry professionals seek in contract manufacturing for parenteral solutions. Ensure quality, compliance, and innovation with our comprehensive guide. Click to learn more.

Contract Manufacturing

Contract Manufacturing Manufacturing Compliance

Telix acquires RLS Radiopharmacies to expand US manufacturing presence

Pharmaceutical Technology

SEPTEMBER 24, 2024

Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.

Manufacturing

AGC Biologics expands viral vector manufacturing capabilities in Milan

Pharmaceutical Technology

AUGUST 9, 2023

AGC has extended its Milan manufacturing facility to address the growing clinical trial and commercial demands.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Trials

Novartis funnels $300M into early biologic drug manufacturing

Bio Pharma Dive

SEPTEMBER 12, 2022

The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline.

Manufacturing

Manufacturing Drugs Medicine Development

Emergent to sell US sterile manufacturing facility to Bora

Pharmaceutical Technology

JUNE 21, 2024

Emergent BioSolutions has agreed to divest its sterile manufacturing facility in Baltimore-Camden, Maryland, to Bora Pharmaceuticals.

Manufacturing

Oligonucleotides: Overcoming sustainability challenges with manufacturing

Pharmaceutical Technology

MARCH 8, 2024

CPI’s new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland could help overcome many challenges with sustainability.

Manufacturing

Vertex and Lonza to establish T1D cell therapy manufacturing facility

Pharmaceutical Technology

JUNE 27, 2023

Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.

Manufacturing

New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. This is important due to the UK’s currently limited short-scale manufacturing capacity.

Gene Therapy

Gene Therapy Manufacturing Gene Clinical Trials

Addressing key challenges in HPAPI manufacturing

Pharmaceutical Technology

APRIL 11, 2024

With specialised production facilities for HPAPIs in great demand, what are the key challenges in manufacturing?

Manufacturing

Manufacturing Production

Fosun Pharma and IFC to build new drug manufacturing plant in Africa

Pharmaceutical Technology

JUNE 7, 2023

The manufacturing site will be completed in three phases and will produce anti-bacterial medicines and anti-malarial drugs. Fosun Pharma chairman Wu Yifang stated: “We are glad to be supported by IFC to localise pharmaceutical manufacturing and distribution in Africa.

Manufacturing

Manufacturing Drugs Production Medicine

Removing snags in cell and gene therapy manufacturing processes with robotics

Pharmaceutical Technology

JULY 31, 2023

Deploying robots in pharmaceutical manufacturing will remove snags in cell and gene therapies and enable breakthroughs

Gene Therapy

Gene Therapy Manufacturing Gene

Cutting Costs with a CDMO: Strategies for Success in Biopharmaceutical Manufacturing

Drug Patent Watch

SEPTEMBER 18, 2024

One key strategy for achieving this balance is partnering with Contract Development and Manufacturing Organizations (CDMOs). To stay competitive, companies must navigate the complexities of biopharmaceutical development while managing costs effectively. In this article, we will explore the… Source

Manufacturing

Manufacturing Development