Manufacturing - Clinical Research Informer

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 Development Compliance Drugs

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

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

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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SynWeave™: Revolutionizing biopharma manufacturing by improving titer, timelines and manufacturability

Bio Pharma Dive

MARCH 10, 2025

Enhancing manufacturability is crucial for reducing the risks associated with scaling production.

Manufacturing

Manufacturing Production

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

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

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

Kyowa Kirin constructs drug manufacturing facility in Japan

Pharmaceutical Technology

APRIL 14, 2025

Kyowa Kirin has concluded the construction of its new drug substance (DS) manufacturing facility, the HB7 building in Japan.

Manufacturing

Manufacturing Drugs

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

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

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

Amgen to invest $900m in Ohio manufacturing facility

Pharmaceutical Technology

APRIL 28, 2025

Amgen has announced a significant expansion of the Ohio manufacturing facility in the US, with an investment of $900m.

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 Vaccine Vaccination

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

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

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

The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

Drug Patent Watch

JANUARY 22, 2025

The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. But what exactly does GMP entail?

Generic Drugs

Generic Drugs Manufacturing Drugs Production

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

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

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

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48

Manufacturing

Manufacturing Development Drugs Compliance

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

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

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

Are European biopharma manufacturers ‘nearshoring’?

Pharmaceutical Technology

MARCH 4, 2025

Experts debate whether European manufacturers are preferring domestic operations as the continent competes with Asia and the US.

Manufacturing

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

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

Transforming manufacturing and packaging at PHARMAP 2025

Pharmaceutical Technology

FEBRUARY 24, 2025

PHARMAP 2025 takes place on 14-15 April 2025 in Berlin, Germany.

Packaging

Packaging Packaging 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

Regeneron partners with Fujifilm to broaden manufacturing capacity

Pharmaceutical Technology

APRIL 22, 2025

Regeneron Pharmaceuticals has entered a new manufacturing and supply agreement with Fujifilm Diosynth Biotechnologies.

Manufacturing

Eli Lilly to expand US pharma manufacturing with four new sites

Pharmaceutical Technology

FEBRUARY 27, 2025

Eli Lilly has announced plans to expand its domestic medicine production in the US with four new pharmaceutical manufacturing sites.

Manufacturing

Manufacturing Medicine Production

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

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

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

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

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

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

Overcoming regulatory challenges in sterile manufacturing

Pharmaceutical Technology

MARCH 25, 2025

Evolving regulations in sterile manufacturing requires innovation, market knowledge, and investment. How can drug manufacturers respond?

Manufacturing

Manufacturing Regulation Marketing Drugs

Catalent backs decentralised manufacture of Galapagos’ CAR-T therapy

Pharmaceutical Technology

JANUARY 22, 2025

Catalent has entered a strategic partnership with Galapagos to facilitate decentralised manufacturing for the latters GLPG5101.

Manufacturing

How AI is streamlining cell and gene therapy manufacturing

Pharmaceutical Technology

FEBRUARY 7, 2025

AI could deliver substantially greater efficiencies in cell and gene therapy manufacturing and enable more patients to benefit.

Gene Therapy

Gene Therapy Manufacturing Gene

Addressing manufacturing challenges in gene therapy development

Bio Pharma Dive

MARCH 20, 2023

As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures.

Gene Therapy

Gene Therapy Gene Development Manufacturing

Cellipont and Secretome link to manufacture cGMP cellular therapy

Pharmaceutical Technology

JANUARY 23, 2025

Cellipont and Secretome Therapeutics are set to enter a collaboration for the manufacturing of the latters cellular therapy, STM-01.

Manufacturing

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

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

Webinars

Trending Sources

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

Webinars

SynWeave™: Revolutionizing biopharma manufacturing by improving titer, timelines and manufacturability

Making the Case for Case Management for Cell and Gene Therapies

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

Cell and gene therapy approvals drive paradigm change in manufacturing

Novo obesity drug sales lag as manufacturing problems persist

Kyowa Kirin constructs drug manufacturing facility in Japan

Roles and Responsibilities of Specialized Clinical Supply Experts

Gene therapy biotech Jaguar spins out manufacturing company

Incannex partners with Catalent to manufacture psilocybin

Amgen to invest $900m in Ohio manufacturing facility

Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Novartis funnels $300M into early biologic drug manufacturing

Bayer expands German manufacturing facilities to fulfill supply demand

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

The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

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

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

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

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Rocket gene therapy rejected by FDA over manufacturing

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

Sustainability in pharmaceutical manufacturing: a CDMO’s contribution

Are European biopharma manufacturers ‘nearshoring’?

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

Telix acquires RLS Radiopharmacies to expand US manufacturing presence

Transforming manufacturing and packaging at PHARMAP 2025

BioNTech partners with Autolus to boost cell therapy manufacturing

Regeneron partners with Fujifilm to broaden manufacturing capacity

Eli Lilly to expand US pharma manufacturing with four new sites

The future of cell and gene therapy manufacturing

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

Lilly to buy injectable drug plant in manufacturing ramp-up

Cell and gene therapy manufacturing: the next generation of startups

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

Novo Nordisk invests $4.1bn in manufacturing facility in NC

Emergent BioSolutions finalises manufacturing site sale to Bora Pharmaceuticals

Overcoming regulatory challenges in sterile manufacturing

Catalent backs decentralised manufacture of Galapagos’ CAR-T therapy

How AI is streamlining cell and gene therapy manufacturing

Addressing manufacturing challenges in gene therapy development

Cellipont and Secretome link to manufacture cGMP cellular therapy

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