Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

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Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

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Pharmaceutical Technology

JANUARY 20, 2023

Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”, The biotech has also made plans to expand manufacturing capacity elsewhere. The manufacturing expansion plans go beyond Covid-19 vaccines and therapeutics. “We

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Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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Pharmaceutical Technology

AUGUST 25, 2022

Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. A cGMP-compliant production facility will be housed at the centre for manufacturing cell products at scale. Topic sponsors are not involved in the creation of editorial content.

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European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine. Top topics at the trade fair include digitalisation, Laboratory 4.0,

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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.

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European Pharmaceutical Review

MARCH 13, 2024

In the paper, the author acknowledged that topical medicinal products require the absence of bacterial species such as P. Conclusion Overall, the method facilitates the “timely monitoring of pharmaceutical preparations and resources to limit contamination throughout the pharmaceutical manufacturing process,” the author asserted.

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PharmaTech

OCTOBER 21, 2022

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

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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.

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Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.

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PharmaTech

FEBRUARY 7, 2023

Built on a reputation of excellence and founded in science, PDA training provides new and experienced professionals around the world with practical information and implementable solutions on essential industry topics related to the manufacturing science, regulation, and technology of drug products and substances.

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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. Topic sponsors are not involved in the creation of editorial content.

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Pharma Leaders

MAY 19, 2023

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals. Related Topics Access the new and newly revised PSGs here.

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Pharma Leaders

MAY 15, 2023

Manufacturers of amphetamine and methylphenidate products, a class of stimulant medications used to treat ADHD and other disorders, must update their labeling and prescribing information to “clearly inform” patients, caregivers and healthcare professionals risks associated with these medications. Related Topics

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European Pharmaceutical Review

OCTOBER 5, 2023

Ahead of her presentation on the future of biomanufacturing at CPHI Barcelona, Sheila Ann Mikhail, the co-founder and former CEO of AskBio, engages in a conversation about gene therapy, artificial intelligence, and the importance of being a well-informed innovator when selecting a manufacturing partner.

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Pharmaceutical Technology

JUNE 8, 2023

FALCON siRNAs can be manufactured at low cost and delivered intrathecally [via the spine], intravenously and subcutaneously. Topic sponsors are not involved in the creation of editorial content. We look forward to the continued development of DTx-1252.”

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Pharma Leaders

MAY 8, 2023

The agency is requesting information on the monitoring and dosing of patients to ensure that concizumab is being administered as intended, as well as further information on the manufacturing process, the company said. Related Topics

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Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. Topic sponsors are not involved in the creation of editorial content. This construction is planned to create over 150 highly skilled jobs.

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Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Pharmaceutical Technology

JULY 12, 2022

Vertex will also gain access to intellectual property around stem cell differentiation and Good Manufacturing Practice (GMP) manufacturing sites for cell-based therapies that could expedite its T1D programmes. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Topic sponsors are not involved in the creation of editorial content. Last year, the companies entered a strategic collaboration.

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Prognos Health

MAY 31, 2023

And as these stakeholders are presented with more and more RWE from pharmaceutical manufacturers, they are asking tough questions to better understand whether to use this evidence when making critical decisions that impact the health of patients.

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Prognos Health

MAY 31, 2023

And as these stakeholders are presented with more and more RWE from pharmaceutical manufacturers, they are asking tough questions to better understand whether to use this evidence when making critical decisions that impact the health of patients.

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Pharmaceutical Technology

JUNE 1, 2023

The funding is being provided under the agency’s Transforming Medicines Manufacturing programme. This unique collaboration can provide the industry with unparalleled access to cutting-edge technologies to accelerate drug design, development, characterisation, and manufacture.

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European Pharmaceutical Review

AUGUST 3, 2022

The ideas and proposals put forward on this topic during the recent EDQM Symposium on Nanomedicines will be taken into account during the process, as will the experience gained with these vaccines during the COVID-19 pandemic, in which mRNA vaccines garnered regulatory approval for the first time.

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PharmaTech

FEBRUARY 23, 2023

We cover topics including regulatory compliance, manufacturer flexibility & supply chain risk and debate the supplier vs partner relationship and the importance of collaboration as we face a challenging future.

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Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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Pharmaceutical Technology

NOVEMBER 16, 2022

A custom-made viral vector and cell therapy centre of excellence, ElevateBio BaseCamp has an end-to-end process development and existing Good Manufacturing Practice (cGMP) production expertise for research, clinical and commercial cell and gene therapies and regenerative treatments.

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Pharmaceutical Technology

OCTOBER 14, 2022

The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients.

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Pharmaceutical Technology

APRIL 20, 2023

The centre will also organise manufacturing-based seminars on topics such as improving wet/dry granulation procedures and approaches for continuous manufacturing.

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Cesare Ferrari

JUNE 17, 2022

For a medical device manufacturer, finding a valuable partner could be a challenge; it requires a rigorous process and a bit of luck. Well, that’s the topic of this post. For example, A distributors, which are the strongest customers for the manufacturer, should always get the best support within the bounds of company policies.

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Pharmaceutical Technology

DECEMBER 8, 2022

Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market. Free Whitepaper.

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PharmaTech

SEPTEMBER 19, 2022

fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing, and fill/finish cGMP manufacturing for sterile injectable and topical products – all under one roof. Discovery the industry's best kept secret.a

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PharmaTech

AUGUST 31, 2022

fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing and fill/finish cGMP manufacturing for sterile injectable and topical products. Here what over 300 decision makers had to say about post-Covid trends - and also the discovery of the industry's best kept secret.a

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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