Manufacturing - Clinical Research Informer

Bluebird preps for split by selling manufacturing plant to well-funded startup

Bio Pharma Dive

JULY 29, 2021

The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ElevateBio finds a new manufacturing home and long-term gene therapy partner in Pittsburgh

Bio Pharma Dive

AUGUST 25, 2022

The biotech signed a 30-year deal with the University of Pittsburgh to establish a gene and cell therapy manufacturing hub that’s being built with a $100 million grant.

Manufacturing

Manufacturing Gene Gene Therapy

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

Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

FEBRUARY 28, 2023

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Yet this is far from straightforward.

Production

Production Manufacturing Engineer Containment

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

Sustainability in pharmaceutical manufacturing: a CDMO’s contribution

Bio Pharma Dive

APRIL 29, 2024

Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.

Manufacturing

Manufacturing Development

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

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Bio Pharma Dive

APRIL 10, 2024

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

Manufacturing

Manufacturing Drugs Trials

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

Advanced technologies in unlocking the future of drug manufacturing

Bio Pharma Dive

MARCH 11, 2024

Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency.

Manufacturing

Manufacturing Drugs

Lilly to buy injectable drug plant in manufacturing ramp-up

Bio Pharma Dive

APRIL 22, 2024

The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.

Manufacturing

Manufacturing Medicine Drugs

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

The future of cell and gene therapy manufacturing

Pharmaceutical Technology

NOVEMBER 30, 2023

As more cell and gene therapies get approved to treat common conditions, scaling them up will be a challenge.

Gene Therapy

Gene Therapy Gene Manufacturing

Novo Nordisk invests $4.1bn in manufacturing facility in NC

Pharmaceutical Technology

JUNE 25, 2024

Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.

Manufacturing

Emergent BioSolutions finalises manufacturing site sale to Bora Pharmaceuticals

Pharmaceutical Technology

AUGUST 21, 2024

The deal, valued at approximately $30m, contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.

Sales

Sales Manufacturing

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

Quality and sustainability: The balancing act for pharma manufacturing

Pharmaceutical Technology

DECEMBER 11, 2023

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

Manufacturing

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Bio Pharma Dive

MAY 17, 2022

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

Manufacturing

Manufacturing Drugs Containment

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

GSK pumps up to $800m for US manufacturing site upgrade

Pharmaceutical Technology

OCTOBER 25, 2024

A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.

Manufacturing

Manufacturing Vaccine Vaccination Drugs

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

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

BioNTech partners with Autolus to boost cell therapy manufacturing

Bio Pharma Dive

FEBRUARY 8, 2024

The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, will give it licensing opportunities and access to supply infrastructure.

Manufacturing

Manufacturing Licensing Licensing

5 ways experience matters in gene therapy manufacturing

Bio Pharma Dive

AUGUST 21, 2023

By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.

Gene Therapy

Gene Therapy Gene 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

Pharmaceutical Packaging Companies in Contract Manufacturing for the Pharmaceutical Industry

Pharmaceutical Technology

SEPTEMBER 24, 2024

Discover the leading Pharmaceutical Packaging Companies, Suppliers & Solutions. Download the free Buyer's Guide today for full details.

Packaging

Packaging Packaging Contract Manufacturing Manufacturing

Cell and gene therapy manufacturing: the next generation of startups

Bio Pharma Dive

JUNE 20, 2023

Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.

Gene Therapy

Gene Therapy Manufacturing Gene Genetics

Bluebird preps for split by selling manufacturing plant to well-funded startup

Gene therapy biotech Jaguar spins out manufacturing company

Trending Sources

Cell and gene therapy approvals drive paradigm change in manufacturing

Novo obesity drug sales lag as manufacturing problems persist

Making the Case for Case Management for Cell and Gene Therapies

Incannex partners with Catalent to manufacture psilocybin

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

Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Bayer expands German manufacturing facilities to fulfill supply demand

Roles and Responsibilities of Specialized Clinical Supply Experts

Robotics: Transforming cell and gene therapy manufacturing

Novartis funnels $300M into early biologic drug manufacturing

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

AGC Biologics expands viral vector manufacturing capabilities in Milan

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

Vertex and Lonza to establish T1D cell therapy manufacturing facility

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

Removing snags in cell and gene therapy manufacturing processes with robotics

ElevateBio finds a new manufacturing home and long-term gene therapy partner in Pittsburgh

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

Resolving challenges with product recovery in biopharma manufacturing

Rocket gene therapy rejected by FDA over manufacturing

Sustainability in pharmaceutical manufacturing: a CDMO’s contribution

FDA rejects Abeona cell therapy, asks for more manufacturing data

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Telix acquires RLS Radiopharmacies to expand US manufacturing presence

Advanced technologies in unlocking the future of drug manufacturing

Lilly to buy injectable drug plant in manufacturing ramp-up

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

The future of cell and gene therapy manufacturing

Novo Nordisk invests $4.1bn in manufacturing facility in NC

Emergent BioSolutions finalises manufacturing site sale to Bora Pharmaceuticals

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

Quality and sustainability: The balancing act for pharma manufacturing

Gilead, having resolved manufacturing issues, forges ahead with HIV drug

FibroBiologics and Charles River link for chronic disease therapies manufacture

GSK pumps up to $800m for US manufacturing site upgrade

PHC uses LiCellGrow prototype for cell and gene therapy manufacture

Chime looks to expand manufacturing capacity and establish European presence

BioNTech partners with Autolus to boost cell therapy manufacturing

5 ways experience matters in gene therapy manufacturing

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

Pharmaceutical Packaging Companies in Contract Manufacturing for the Pharmaceutical Industry

Cell and gene therapy manufacturing: the next generation of startups

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