Development and 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

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

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

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. The latest development follows an internal analysis of the preliminary results of the Phase II PsiGAD clinical trial.

Manufacturing

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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

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

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

Axovant shares sink on manufacturing delay for Parkinson's gene therapy

Bio Pharma Dive

OCTOBER 30, 2020

A longer-than-expected timeline for developing a new manufacturing process means a key study for Axovant's top gene therapy likely won't begin until 2022.

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

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

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. Personalised medicines will also be developed at the centre.

Gene Therapy

Gene Therapy Manufacturing Gene Clinical Trials

Forge Biologics and Labcorp partner for gene therapies development

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. In April 2023, Forge Biologics received a qualified person (QP) declaration for the manufacture of AAV gene therapies at its facility in Columbus, Ohio, US.

Gene Therapy

Gene Therapy Gene Development Manufacturing

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

Sanofi to aid Moderna on final steps in manufacturing coronavirus vaccine

Bio Pharma Dive

APRIL 26, 2021

The French pharma has agreed to "fill and finish" up to 200 million vials of Moderna's shot at its New Jersey plant, the third such manufacturing deal it struck with other vaccine developers.

Manufacturing

Manufacturing Vaccination Vaccine Development

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

Development

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Genevoyager opens CDMO facility for gene therapy development

Pharmaceutical Technology

DECEMBER 21, 2023

Genevoyager has announced the opening of contract development and manufacturing organisation facility to manufacture gene therapy products.

Gene Therapy

Gene Therapy Gene Development Manufacturing

How to Develop a Sustainable Generic Drug Development Strategy

Drug Patent Watch

DECEMBER 11, 2024

This article outlines key considerations and strategies for developing a sustainable generic drug development strategy. Green Chemistry and Sustainable Manufacturing Green chemistry principles play a significant role in reducing environmental impacts. Green Chemistry: A More Sustainable Approach to Medicine Development.

Generic Drugs

Generic Drugs Development Drugs Compliance

ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

Bio Pharma Dive

SEPTEMBER 17, 2024

The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.

Development

Development Manufacturing 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

How did pharma develop a vaccine so quickly?

World of DTC Marketing

DECEMBER 29, 2020

OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The post How did pharma develop a vaccine so quickly?

Vaccination

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The Future of Generic Drug Development for Emerging Markets: Opportunities and Challenges

Drug Patent Watch

JANUARY 23, 2025

The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. Share your thoughts in the comments below! Read the full article here: [link]

Generic Drugs

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Seattle institute lands $18m funding to develop RNA vaccine for chikungunya

Pharmaceutical Technology

AUGUST 3, 2023

AAHI is developing a novel RNA vaccine that overcomes manufacturing and storage limitations to increase accessibility.

RNA

RNA Vaccination Vaccine Development

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

Forge Biologics joins BGTC for new AAV gene therapies development

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Shilling was appointed to represent the company on the steering committee of the BGTC.

Gene Therapy

Gene Therapy Gene Development Manufacturing

Umoja and IASO partner to develop therapies for haematological malignancies

Pharmaceutical Technology

NOVEMBER 22, 2022

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. The post Umoja and IASO partner to develop therapies for haematological malignancies appeared first on Pharmaceutical Technology.

Development

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New UK intracellular drug delivery centre to support RNA development

Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. The funding is being provided under the agency’s Transforming Medicines Manufacturing programme.

Drug Delivery

Drug Delivery RNA Development Drugs

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

Pharmaceutical Technology

JANUARY 20, 2023

In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA technology. In 2021, Moderna had a net income of $12.2

Manufacturing

Manufacturing Vaccination Vaccine Gene Therapy

Astellas to support development of Taysha’s gene therapy programmes

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy

Gene Therapy Gene Development Genetics

Oragenics secures CQDM funding for Covid-19 vaccine antigen development

Pharmaceutical Technology

JUNE 6, 2023

Oragenics has secured funding from the Canadian bioresearch consortium CQDM to develop a variant-agnostic protein antigen for use in its Covid-19 intranasal vaccine. In March 2023, Oragenics and Inspirevax entered an exclusive global licence deal to develop the former’s lead intranasal Covid-19 vaccine candidate, NT-CoV2-1.

Vaccination

Vaccination Vaccine Development Manufacturing

Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

JANUARY 14, 2025

But how do companies develop these cost-effective alternatives? Case Study 1: Overcoming Formulation Challenges Let’s kick things off with a look at how generic drug manufacturers are tackling formulation challenges head-on. Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1].

Generic Drugs

Generic Drugs Development Drugs Manufacturing

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

ElevateBio and Affini-T collaborate to develop T cell therapies

Pharmaceutical Technology

NOVEMBER 16, 2022

Under the deal, the LentiPeak lentiviral vector technology platform and cell therapy production expertise of ElevateBio BaseCamp will be used by Affini-T to develop its investigational oncogenic driver programmes in the clinic. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Development

Development Gene Therapy Engineer Gene Editing

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

Kite and Arcellx enter partnership for multiple myeloma therapy development

Pharmaceutical Technology

DECEMBER 12, 2022

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Kite will carry out the manufacturing following the technical transfer.

Development

Development Gene Therapy Clinical Trials Clinical Trials

Expert Insights: Development and Manufacture of Highly Potent Oral Liquids

XTalks

JANUARY 30, 2025

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients.

Manufacturing

Manufacturing Development Compliance Production

Merck and Orion enter partnership to develop ODM-208 for prostate cancer

Pharmaceutical Technology

JULY 13, 2022

Merck (MSD outside North America) and Orion have entered an international agreement to develop and market the latter’s investigational candidate ODM-208 to treat metastatic castration-resistant prostate cancer (mCRPC). Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer.

Development

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BioNTech and DualityBio team up to develop ADC therapeutics for cancer

Pharmaceutical Technology

APRIL 3, 2023

BioNTech has signed exclusive licence and collaboration agreements with Duality Biologics (DualityBio) for the development of two antibody-drug conjugate (ADC) assets for solid tumours. The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe.

Development

Development Sales Antibody Manufacturing

GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

Vaccination

Vaccination Vaccine Development RNA

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

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. . The latest development is part of the expansion plans of BioNTech to boost its international footprint in Asia. .

Manufacturing

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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