Manufacturing - Clinical Research Informer

Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

OCTOBER 14, 2024

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

Gene Therapy

Gene Therapy Manufacturing Gene

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

Centre to amend MDR to detail timelines related to medical devices manufacturing license

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 24, 2024

In order to better streamline the approval process for manufacturing license to the medical devices units, the Central government is looking at amending the relevant rules in the Medical Device Rules (MDR), 2017 to include various timelines related to grant of manufacturing license to the four classes of medical devices in the country.

Licensing

Licensing Licensing Manufacturing Clinical Trials

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

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

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 21, 2024

By investing in advanced labs, manufacturing facilities, regulatory compliance systems, cybersecurity, and global supply chains, companies can ensure they meet […] It ensures scalability, quality control, and regulatory compliance.

Manufacturing

Manufacturing Compliance Development Drugs

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

GSK invests $800M in manufacturing; Amgen sets small discount for Eylea biosimilar

Bio Pharma Dive

OCTOBER 25, 2024

manufacturing investment. The British pharma is making what it calls its largest U.S. Elsewhere, AbbVie expanded a longstanding partnership and Marinus said it would lay off staff.

Manufacturing

Injectables manufacturing ushers in a new era of accessibility

Pharmaceutical Technology

NOVEMBER 4, 2024

Increasingly, injectable manufacturers recognise that to achieve maximum profitability, they need to focus on the value they provide.

Manufacturing

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

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

FibroBiologics and Charles River link for chronic disease therapies manufacture

Pharmaceutical Technology

OCTOBER 21, 2024

FibroBiologics has entered a master services agreement with Charles River Laboratories to develop and manufacture cell-based therapies.

Manufacturing

Manufacturing Development

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

Parenteral Solutions in Contract Manufacturing for the Pharmaceutical Industry

Pharmaceutical Technology

OCTOBER 15, 2024

Discover the leading Parenteral Solutions in Pharmaceutical Contract Manufacturing. Download the free Buyer's Guide for full contact details.

Contract Manufacturing

Contract Manufacturing Manufacturing

CPI’s Medicines Manufacturing Innovation Centre takes delivery of PACE Just in Time (JIT) Clinical Trials Drug Dispensing System

Pharmaceutical Technology

NOVEMBER 29, 2024

Automated Industrial Robotics have delivered a bespoke Just in Time PACE system to CPI’s new Medicines Manufacturing Innovation Centre.

Manufacturing

Manufacturing Medicine Clinical Trials Clinical Trials

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

Fresenius Kabi and Cellular Origins agree CGT manufacture automation

Pharmaceutical Technology

OCTOBER 17, 2024

Fresenius Kabi and Cellular Origins have announced a partnership to advance cell and gene therapy (CGT) by automating manufacturing.

Manufacturing

Manufacturing Gene Therapy Gene

Sanofi opens $595m manufacturing facility in Singapore

pharmaphorum

NOVEMBER 29, 2024

Sanofi has officially opened a modular biologics manufacturing facility in Singapore that is designed to allow rapid switching between products.

Manufacturing

Manufacturing Production

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

Magazine: Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

OCTOBER 8, 2024

In this issue: The manufacturing shift to meet growing cell and gene therapy demand, applying lessons from the Covid-19 pandemic to address mpox, a ten-year review of Opdivo and Keytruda, and more.

Gene Therapy

Gene Therapy Manufacturing Gene

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

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

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

Optimizing Generic Drug Manufacturing: Strategies for Success

Drug Patent Watch

NOVEMBER 13, 2024

To remain competitive and profitable, generic drug manufacturers must adopt innovative strategies to optimize their manufacturing processes. The generic drug industry faces significant challenges, including unstable economics, supply chain disruptions, and intense competition.

Generic Drugs

Generic Drugs Manufacturing 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

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

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Pharmaceutical Technology

OCTOBER 3, 2024

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

Manufacturing

Manufacturing Medicine Production Trials

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

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

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

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

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

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 Medicine Drugs Development

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

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 Vaccine Vaccination

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

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

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

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

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

Accord will build £50m manufacturing plant in UK

pharmaphorum

NOVEMBER 4, 2024

Accord Healthcare unveils £50m investment, backed by the UK government, that will see a new manufacturing facility built in Newcastle

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

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

Cell and gene therapy approvals drive paradigm change in manufacturing

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

Trending Sources

Centre to amend MDR to detail timelines related to medical devices manufacturing license

Gene therapy biotech Jaguar spins out manufacturing company

Making the Case for Case Management for Cell and Gene Therapies

Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

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

GSK invests $800M in manufacturing; Amgen sets small discount for Eylea biosimilar

Injectables manufacturing ushers in a new era of accessibility

Roles and Responsibilities of Specialized Clinical Supply Experts

Incannex partners with Catalent to manufacture psilocybin

FibroBiologics and Charles River link for chronic disease therapies manufacture

Rocket gene therapy rejected by FDA over manufacturing

Parenteral Solutions in Contract Manufacturing for the Pharmaceutical Industry

CPI’s Medicines Manufacturing Innovation Centre takes delivery of PACE Just in Time (JIT) Clinical Trials Drug Dispensing System

Bayer expands German manufacturing facilities to fulfill supply demand

Fresenius Kabi and Cellular Origins agree CGT manufacture automation

Sanofi opens $595m manufacturing facility in Singapore

Robotics: Transforming cell and gene therapy manufacturing

Magazine: Cell and gene therapy approvals drive paradigm change in manufacturing

PHC uses LiCellGrow prototype for cell and gene therapy manufacture

Biotechnology Equipment Manufacturers, Companies and Suppliers for the Pharmaceutical Industry

Novo obesity drug sales lag as manufacturing problems persist

Optimizing Generic Drug Manufacturing: Strategies for Success

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

Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Medical packaging companies in pharmaceutical contract manufacturing

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

Chime looks to expand manufacturing capacity and establish European presence

FDA rejects Abeona cell therapy, asks for more manufacturing data

Pharmaceutical clean room manufacturing, flooring and design

Pharmaceutical Lyophilization Manufacturers, Companies and Solutions

Novartis funnels $300M into early biologic drug manufacturing

Leading peptide manufacturers: Custom solutions and quality assurance

AstraZeneca may pull plug on UK vaccine manufacturing plans

AGC Biologics expands viral vector manufacturing capabilities in Milan

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

Vertex and Lonza to establish T1D cell therapy manufacturing facility

Oral solid dosage manufacturing companies, equipment and market

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

Accord will build £50m manufacturing plant in UK

Oligonucleotides: Overcoming sustainability challenges with manufacturing

Parenteral Solutions in Contract Manufacturing for the Pharmaceutical Industry

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