Pharmaceutical Technology

APRIL 18, 2023

Eli Lilly and Company (Lilly) has unveiled plans to invest $1.6bn in its two new manufacturing facilities located within the LEAP Innovation Park in Boone County, Indiana, US. The investment at the LEAP site marks the company’s biggest manufacturing investment at a single location to date. “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. These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets.

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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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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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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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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.

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pharmaphorum

MARCH 26, 2021

There’s a new kid on the block among companies using artificial intelligence in drug discovery, after 1910 Genetics launched today with $26 million in financing. 1910 Genetics is named after the year in which sickle cell disease (SCD) was first discovered in the US by James Herrick.

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pharmaphorum

JANUARY 6, 2021

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work. This thought leadership series has been paid and developed by Kite, a Gilead Company. The journey of the cell.

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World of DTC Marketing

DECEMBER 29, 2020

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package.

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Roots Analysis

JANUARY 27, 2025

Cell therapies are based on the premise that the patients own cells (autologous), or those from a healthy donor (allogeneic), can be genetically re-programmed to combat various diseases. It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process.

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Pharmaceutical Technology

JUNE 8, 2023

DTx-1252 targets the underlying genetic lesion of the disease and leverages our FALCON platform to unlock the promise of RNAi therapeutics. “We FALCON siRNAs can be manufactured at low cost and delivered intrathecally [via the spine], intravenously and subcutaneously. We look forward to the continued development of DTx-1252.”

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Pharmaceutical Technology

JULY 7, 2022

Genetic mutations, both germline and acquired, are behind a large proportion of the most debilitating and sometimes life-threatening human diseases. But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients.

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STAT News

APRIL 3, 2023

The first CRISPR treatment for sickle cell disease has been submitted to the Food and Drug Administration, beating a rival gene therapy that’s been delayed due to a manufacturing issue.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

The company has presently attained steady manufacturing of several innovative vaccines and set up a supply chain worldwide to increase accessibility to quality vaccine products for people globally.

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Pharmaceutical Technology

MAY 26, 2023

VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM). It prevents epidermis adhesion to the dermis.

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Pharmaceutical Technology

JUNE 29, 2022

For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The enzymes must be manufactured under cGMP conditions – completely free of animal-derived ingredients.”. Developing best-in-class speciality enzymes.

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XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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Pharmaceutical Technology

JUNE 24, 2022

The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA.

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Pharmaceutical Technology

MAY 24, 2023

The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine. CGT trials operate with much lower volumes of manufactured final product. CGT have highly unique and specialized manufacturing processes.

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Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). However, in patients with urea cycle disorders, genetic defects result in inadequate amounts of the enzymes needed to convert nitrogen into urea.

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Pharmaceutical Commerce

JUNE 25, 2024

The latest news for pharma industry insiders.

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Pharmaceutical Technology

DECEMBER 8, 2022

With a five-day manufacturing process, the enzymatic production approach of Touchlight will back Odimma in developing its programme. . Touchlight CEO Karen Fallen said: “Innovation in enzymatic DNA manufacturing is enabling advancements such as Odimma’s immunotherapy programme to deliver treatments to critically ill patients.

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XTalks

MARCH 27, 2024

The collaboration between IVD manufacturers and lab testing partners is central to precise and efficient diagnostic processes. So, what considerations should IVD manufacturers bear in mind when determining this crucial partnership? But why should IVD manufacturers choose Quest Diagnostics as one of these partners?

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Pharmaceutical Technology

MAY 25, 2023

ElevateBio intends to use the funds to advance its genetic medicine current good manufacturing practice (cGMP) and process development business, BaseCamp. The proceeds will support the company to increase its cGMP manufacturing capacity and expand its geographic reach.

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Drug Patent Watch

DECEMBER 12, 2024

Key Factors Influencing Generic Entry To identify branded drugs with a low likelihood of generic entry, it’s crucial to understand the factors that influence generic manufacturers’ decisions to enter a market. This complexity can serve as a barrier to entry for potential generic manufacturers.

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Pharmaceutical Technology

NOVEMBER 7, 2022

Leveraging its cell expansion and activation technology as well as cell manufacturing capabilities, the company can extend NK cells while substantially boosting cytotoxicity across peripheral blood-derived products. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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Pharmaceutical Technology

MAY 22, 2023

Thermo Fisher Scientific has expanded its sterile manufacturing and research capabilities in the Asia-Pacific region with the opening of a new sterile drug facility in Singapore. The new good manufacturing practices facility was established with support from the Singapore Economic Development Board.

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Pharmaceutical Technology

DECEMBER 12, 2022

The alliance will utilise the capabilities of both firms, including international cell therapy leadership and manufacturing of Kite. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma. Kite will carry out the manufacturing following the technical transfer.

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BioPharma Reporter

JANUARY 25, 2024

Genetic Design and Manufacturing Corporation (GDMC) has bagged $21 million in Series A funding to accelerate its next-gen advanced genetic therapies.

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XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.

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Scienmag

MAY 31, 2021

NIH- and USU- led study links ALS to a fat manufacturing gene and maps out a genetic therapy Credit: Courtesy of the NIH/NINDS.

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BioPharma Reporter

SEPTEMBER 23, 2020

Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.

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XTalks

MARCH 17, 2025

Recent pre-mass production trials tests conducted to ensure that the devices meet performance and manufacturing quality standards before full-scale production demonstrated that the A+Pre chip recovered 94% of tumor cells, while the AC-1000 achieved a 79.5% recovery rate, surpassing their performance targets.

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STAT News

FEBRUARY 22, 2023

The Cambridge biotech company announced Wednesday that it will partner with Life Edit Therapeutics to develop potentially permanent treatments for rare genetic diseases and other conditions. Life Edit is the North Carolina subsidiary of ElevateBio, a cell and gene therapy manufacturing firm in Waltham.

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BioPharma Reporter

APRIL 7, 2021

The UK has a strong genetics research base: but to date, academics have found it difficult to progress gene therapy research into clinical trials and beyond. The Sheffield Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three new hubs, announced this month, that will tackle these challenges.

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Pharmaceutical Technology

JANUARY 12, 2023

Under the research partnership deal, the companies will develop new precision genetic medicines for a severe form of genetic dilated cardiomyopathy (DCM). Solid Biosciences stated that the partnership boosts its scientific capabilities along with commercial potential in cardiac therapy.

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Pharmaceutical Technology

DECEMBER 27, 2022

In a data-backed analysis, she further explored how the most number of designations are awarded to cancer drugs , and genetic disorders have the largest share of orphan therapies. In pharma manufacturing, continuous manufacturing protocols continued to garner interest , but experts told Adam that their use has been gradual.

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