Manufacturing and Production - 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

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

Manufacturing

Manufacturing Development Compliance Drugs

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. Increasing product yield is the most fundamental way to achieve this.

Production

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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

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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

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. It is crucial to ensure supply chain risks are mitigated and have proactive strategies in place to address unforeseen challenges before they become an issue.

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 be potentially used for wider commercial use or supply as a cGMP pharmaceutical-grade product.

Manufacturing

Manufacturing Clinical Trials Clinical Trials Production

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

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

APRIL 13, 2023

The initial agreement between Dyadic and Rubic involved discovery, development, manufacturing, and distribution of Covid-19 vaccines by transferring and licensing of C1 platform technology. The now expanded agreement will enable Rubic to explore other therapeutic avenues in both the human and animal health product markets.

Production

Production Vaccination Vaccine Protein

Bristol Myers taps startup to boost CAR-T production

Bio Pharma Dive

APRIL 22, 2024

A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.

Production

Production Manufacturing

Bristol Myers boosts cell therapy production with Novartis plant

Bio Pharma Dive

APRIL 26, 2023

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

Production

Production Manufacturing Drugs

Best Features of Mobile Workstations in Pharmaceutical Production

Pharma Mirror

DECEMBER 14, 2020

The future of pharmaceutical manufacturing is mobile. has led to the proliferation of mobile IT solutions for manufacturing, including pharmaceuticals. The post Best Features of Mobile Workstations in Pharmaceutical Production appeared first on Pharma Mirror Magazine. Advances in cloud computing and the onset of Industry 4.0

Production

Production Manufacturing

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

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

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

MAY 6, 2022

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.

Production

Production Drugs Manufacturing

Astellas and Yaskawa form JV for cell therapy product manufacture

Pharmaceutical Technology

MARCH 7, 2025

Astellas Pharma and Yaskawa have agreed to form a JV that will focus on developing a cell therapy product manufacturing platform.

Manufacturing

Manufacturing Production Development

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

J&J to oversee vaccine production at Emergent factory that ruined doses

Bio Pharma Dive

APRIL 5, 2021

The change, which follows the contractor's costly manufacturing mix-up, will displace production of AstraZeneca's unauthorized shot at the Baltimore site.

Production

Production Vaccination Vaccine Manufacturing

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

Pharmaceutical Technology

JUNE 7, 2023

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The manufacturing site will be completed in three phases and will produce anti-bacterial medicines and anti-malarial drugs.

Manufacturing

Manufacturing Drugs Production Medicine

Bristol Myers CAR-T sales rise, despite production problems

Bio Pharma Dive

JULY 27, 2022

A manufacturing issue for Breyanzi, meanwhile, impacted sales. Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving.

Sales

Sales Production Manufacturing

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing

Manufacturing Marketing Pharma Companies Vaccination

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

DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)

Manufacturing

Manufacturing Production Drugs Clinical Trials

Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

Bio Pharma Dive

OCTOBER 4, 2022

The Japanese drugmaker said it was unable to resolve manufacturing problems that led to a 2019 recall of the drug, which treats hypoparathyroidism.

Production

Production Drugs Manufacturing

Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage. The quality and purity of these ingredients can greatly impact the final product's efficacy and safety.

Generic Drugs

Generic Drugs Production Compliance Drugs

Vaccine production in focus as Moderna, Pfizer await FDA decision

Bio Pharma Dive

DECEMBER 4, 2020

Moncef Slaoui, a leader of Operation Warp Speed, said he expects 100 million Americans to be vaccinated by the end of February — an ambitious target even as Moderna and Pfizer ramp up manufacturing.

Vaccination

Vaccination Vaccine Production Manufacturing

Cereno partners with CordenPharma to scale up CS1 drug production

Pharmaceutical Technology

JANUARY 12, 2024

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

Production

Production Drugs Manufacturing

Croda Pharma and BSI partner for vaccine adjuvant QS-21 production

Pharmaceutical Technology

MAY 23, 2023

Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade vaccine adjuvant QS-21. The plentiful supply of QS-21 enables the production of next-generation adjuvant systems for new vaccine development.”

Vaccination

Vaccination Vaccine Production Life Science

California to manufacture its own insulin, governor says

Bio Pharma Dive

JULY 11, 2022

Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures.”

Insulin

Insulin Manufacturing Production Medicine

An Indiana startup aims to boost the US drug manufacturing push

Bio Pharma Dive

OCTOBER 21, 2020

effort to onshore production of pharmaceuticals. Incog BioPharma Services has become the latest entity to sprout up as part of a concerted U.S.

Manufacturing

Manufacturing Production Drugs

Startup Cellares adds $255M as investors pour cash into cell therapy production

Bio Pharma Dive

AUGUST 24, 2023

Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.

Production

Production 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

Drugmakers push forward on large-scale production of coronavirus vaccines

Bio Pharma Dive

SEPTEMBER 24, 2020

HHS Secretary Alex Azar said six vaccine developers involved with Operation Warp Speed had begun commercial manufacturing of their experimental shots.

Vaccination

Vaccination Vaccine Production Manufacturing

Moderna takes aim at global expansion plans with manufacturing ramp-up

Pharmaceutical Technology

JANUARY 20, 2023

Bancel explained that this deal will “shrink the time to get from designing the sequence to having products ready by two more weeks”. Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”, said Bancel.

Manufacturing

Manufacturing Vaccination Vaccine Gene Therapy

BioNTech to acquire GMP manufacturing facility in Singapore

Pharmaceutical Technology

NOVEMBER 14, 2022

BioNTech’s Singapore affiliate BioNTech Pharmaceuticals Asia Pacific has signed an agreement with Novartis Singapore Pharmaceutical Manufacturing to acquire a GMP-certified manufacturing site in the country. . It also has the potential for extension into the manufacturing of other drug classes such as cell therapies. .

Manufacturing

Manufacturing Vaccination Vaccine Production

Chinese manufacturers’ transition to innovative pharma requires more investment

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

Manufacturing

Manufacturing Gene Therapy Gene Contract 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

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

Novo Nordisk to invest over $2B in drug ingredient production

Bio Pharma Dive

JUNE 12, 2023

The company said the spending will help it manufacture future treatments for chronic diseases, adding to a string of recent plant investments.

Production

Production Manufacturing Drugs

Terumo and GenCure sign agreement for cell and gene therapies

Pharmaceutical Technology

JUNE 29, 2022

Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In the initial stage, the alliance will use Terumo and GenCure’s capabilities to set up a reference manufacturing centre for BioBridge.

Gene Therapy

Gene Therapy Gene Manufacturing Production

MSD expands vaccine production with new $1bn facility

Pharmaceutical Technology

MARCH 11, 2025

MSD has opened a $1bn facility in Durham located in the US state of North Carolina, to increase vaccine manufacturing capacity.

Vaccination

Vaccination Vaccine Production Manufacturing

A new biotech wants to ease a bottleneck in cell and gene therapy production

Bio Pharma Dive

APRIL 11, 2023

Founded by University of Pennsylvania researchers, VintaBio will manufacture the viral vectors that are essential in cell and gene therapy production, but which have been in shorter supply as more companies entered the space.

Gene Therapy

Gene Therapy Gene Production Manufacturing

Addressing supply chain challenges for biosimilar products

Drug Patent Watch

MARCH 13, 2025

From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

Production

Production Compliance Manufacturing Marketing

AstraZeneca to establish $1.5bn ADC production site in Singapore

Pharmaceutical Technology

MAY 21, 2024

AstraZeneca is set to invest $1.5bn in a new manufacturing facility in Singapore dedicated to the production of antibody drug conjugates.

Production

Production Antibody Manufacturing Drugs

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

Resolving challenges with product recovery in biopharma manufacturing

Webinars

Trending Sources

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

Webinars

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

Making the Case for Case Management for Cell and Gene Therapies

Incannex partners with Catalent to manufacture psilocybin

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

Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Bristol Myers taps startup to boost CAR-T production

Bristol Myers boosts cell therapy production with Novartis plant

Best Features of Mobile Workstations in Pharmaceutical Production

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

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

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Astellas and Yaskawa form JV for cell therapy product manufacture

Moderna to set up new mRNA manufacturing facility in Kenya

J&J to oversee vaccine production at Emergent factory that ruined doses

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

Bristol Myers CAR-T sales rise, despite production problems

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Brazil: untapped market for big pharma manufacturing

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

DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Vaccine production in focus as Moderna, Pfizer await FDA decision

Cereno partners with CordenPharma to scale up CS1 drug production

Croda Pharma and BSI partner for vaccine adjuvant QS-21 production

California to manufacture its own insulin, governor says

An Indiana startup aims to boost the US drug manufacturing push

Startup Cellares adds $255M as investors pour cash into cell therapy production

Eli Lilly to expand US pharma manufacturing with four new sites

Drugmakers push forward on large-scale production of coronavirus vaccines

Moderna takes aim at global expansion plans with manufacturing ramp-up

BioNTech to acquire GMP manufacturing facility in Singapore

Chinese manufacturers’ transition to innovative pharma requires more investment

PHC uses LiCellGrow prototype for cell and gene therapy manufacture

Addressing key challenges in HPAPI manufacturing

Novo Nordisk to invest over $2B in drug ingredient production

Terumo and GenCure sign agreement for cell and gene therapies

MSD expands vaccine production with new $1bn facility

A new biotech wants to ease a bottleneck in cell and gene therapy production

Addressing supply chain challenges for biosimilar products

AstraZeneca to establish $1.5bn ADC production site in Singapore

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