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 162

Manufacturing Gene Therapy Gene Contract Manufacturing 162

Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

Gene 100

Gene Marketing Vaccine Vaccination 100

Pharma Manufacturing

AUGUST 15, 2022

Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products

Packaging 40

Packaging Packaging Gene Therapy Gene 40

Pharmaceutical Technology

APRIL 11, 2023

Sarepta Therapeutics has announced May 12 as the date of a highly anticipated US Food and Drug Administration’s (FDA) Advisory Committee meeting to consider the approval of its SRP-9001 gene transfer therapy for Duchenne muscular dystrophy (DMD).

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

Packaging 40

Packaging Packaging Containment Production 40

Pharmaceutical Technology

AUGUST 17, 2022

These molecules synthesised newly are packaged densely into custom lipid nanoparticles (LNPs), which Orna has made to act on the body’s crucial tissues. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

RNA 147

RNA Vaccine Vaccination In-Vivo 147

The Pharma Data

MARCH 7, 2022

By combining CRISPR technology with a protein designed with artificial intelligence (AI), it is possible to awaken individual dormant genes by disabling the chemical “off switches” that silence them. The chemical modifications that regulate gene activity are called epigenetic markers. it can be reawakened.

Protein 52

Protein Gene Genome Genomics 52

STAT News

NOVEMBER 4, 2022

A man with muscular dystrophy who was first in line to receive an experimental gene editing therapy tailor made to treat the cause of his rare form of the disease has died. The treatment used a new version of CRISPR to turn on a backup copy of the dystrophin gene that mysteriously lies dormant in our muscles.

Gene Editing 105

Gene Editing Gene Gene Therapy Scientist 105

pharmaphorum

JUNE 28, 2021

The reductions matched the efficacy of current therapies for ATTR amyloidosis that require chronic dosing such as Alnylam’s Onpattro (patisiran) and Ionis/Akcea’s Tegsedi (inotersen) – both gene-silencing agents which can cost around $450,000 a year. — Eric Topol (@EricTopol) June 26, 2021.

In-Vivo 105

In-Vivo Gene Editing Trials Drugs 105

Camargo

JULY 30, 2021

But now it’s a warning in their package insert. That has to do a lot with the work in gene therapy and rare disease and the ultra-rare space because there are 7,000 rare diseases that have been identified. But I believe that the future of pediatrics is going to be in gene therapy, cell therapy.

Clinical Research 226

Clinical Research Research Gene Therapy Drugs 226

Pharmaceutical Technology

AUGUST 31, 2022

As we continue to grow and meet demand, we will remain focused on providing broader and more integrated workflow solutions within the biopharma, cell & gene therapy, and related life sciences end markets.”. Production takes place in a US-based facility that is certified cGMP-compliant and is suitable for ISO 7 cleanroom classifications.

Packaging 130

Packaging Packaging Production Containment 130

Cloudbyz

MARCH 30, 2023

Cell and gene therapies are rapidly becoming an essential component of modern medicine, offering hope to patients with previously untreatable diseases. However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

STAT News

APRIL 6, 2023

They may involve infusions of a gene packaged inside the shell of a virus, which can lead to potential immune complications and can require close monitoring of patients. Promising therapies for some diseases are administered through lumbar punctures, which are not a routine part of a doctor’s daily practice.

Doctor 98

Doctor Doctors Drugs Packaging 98

Pharma Packaging Solutions

JUNE 30, 2023

Gene Therapy: Gene therapy is a biologic treatment that involves manipulating a virus to carry a certain, desirable piece of genetic material which can then target a patient’s cells. As biopharma technology progresses, becoming both more prevalent and available, the need for high-quality biopharma packaging increases.

Recombinant DNA Technology 52

Recombinant DNA Technology Packaging Packaging Gene Therapy 52

Camargo

JANUARY 12, 2022

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. Receipt of Background Package. Response Time. calendar days).

Production 169

Production Gene Therapy Packaging Packaging 169

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. CluePoints provides clinical studies with risk management support package during Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

Pharma Packaging Solutions

SEPTEMBER 22, 2023

There are a few common types of biologics, including extracted (taken directly from a living system), semi-synthesized (produced with recombinant DNA technology), vaccines, and gene therapies. Covid-19, flu, coronavirus liquid vaccine vial bottle and syringe set in plastic package container preparing for injection on white background.

Recombinant DNA Technology 52

Recombinant DNA Technology Packaging Packaging Pharma Packaging 52

The Pharma Data

OCTOBER 26, 2020

The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein. Sensorion is currently advancing two preclinical gene therapy programs conducted under a broad multi-program research partnership with the Genetics and Physiology of Hearing Unit at Institut Pasteur (Paris).

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

The Pharma Data

JULY 11, 2021

Eli Lilly and Company (NYSE: LLY) announced new Phase 2 data showing that gene expression changes induced by mirikizumab in patients with ulcerative colitis (UC) over a 12-week induction treatment were maintained for up to one year. For methodology, see the “About the Studies” section below.

Regulation 52

Regulation Gene Gene Expression Packaging 52

The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics.

Clinical Supply 52

Clinical Supply Gene Therapy Gene Development 52

Pharmaceutical Technology

MAY 26, 2023

The acquisition targets had a wide variety of manufacturing services, including API and dose manufacturing, packaging, and analytical services. These acquisitions focused on advanced cell and gene therapy capabilities. Catalent Inc.

Life Science 130

Life Science Manufacturing Contract Manufacturing Gene Therapy 130

Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area.

Production 190

Production Trials Development Clinical Trials 190

Pharmaceutical Technology

DECEMBER 9, 2022

The move is particularly timely given the significant growth expected in global sales of cell and gene therapies. Our QC testing capabilities range from solids, semi-solids and liquids for oral, inhaled and injectable use to packaging materials, including rubber closures, glass and plastic containers. HQ ADDRESS: Römerpark 2.

Development 130

Development Production Manufacturing Vaccine 130

pharmaphorum

JUNE 1, 2022

Spark Therapeutics developed a VR product , alongside a partner, to teach haemophilia patients about gene therapy. VR for real world education. This has not escaped the notice of pharmaceutical companies looking to educate patients on topics, with which they may not have the most health literacy.

Vaccine 145

Vaccine Vaccination Doctor Doctors 145

pharmaphorum

AUGUST 19, 2020

Our community of supply chain experts are looking forward to connecting with you in the digital world, including: Christopher Baldwin , Supply Chain Director, Cell & Gene Therapy¸ GSK. Reggie Foster , Senior Director Labelling, Logistics & Packaging, Kite: a Gilead Company.

Gene Therapy 52

Gene Therapy Packaging Packaging Branding 52

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

Manufacturing 52

Manufacturing Packaging Packaging Production 52

Scienmag

APRIL 14, 2021

In the cell nucleus histones play a crucial role packaging DNA into chromatin. Histones are however very sticky to both DNA and RNA, so to ensure they are transported to the cell nucleus after synthesis and bind to the right portion of DNA to organize the chromatin, they are guarded by complexes of histone chaperones. […].

Protein 40

Protein DNA RNA Packaging 40

FDA Law Blog

NOVEMBER 2, 2023

While on the surface this may not seem like major advance for the field, this could be a game changer for the gene therapy space. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

Medicine 59

Medicine Gene Therapy Gene Production 59

Cloudbyz

JUNE 21, 2023

Utilize SDTM Conversion Tools: To convert the extracted data into SDTM format, employ SDTM conversion tools or software packages available in the market. Exported data may be in a raw format (e.g., CSV, Excel) or in a vendor-specific format compatible with SDTM conversion tools.

Clinical Trials 93

Clinical Trials Clinical Trials Compliance Trials 93

BioSpace

NOVEMBER 23, 2022

BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.

Gene Therapy 40

Gene Therapy Gene Packaging Packaging 40

pharmaphorum

APRIL 11, 2022

As part of this, innovative treatments such as CAR-T therapy and retinal gene therapy are emerging as ways to target rare diseases, multiple indications and underserved populations. According to EFPIA, there are over 7,000 medicines currently in development globally.

Medicine 115

Medicine Clinical Trials Clinical Trials Development 115

pharmaphorum

MARCH 10, 2022

This trend will continue in the near future with a steady increase in market demand over the coming years, alongside further development in cell and gene therapies,” says Magnelli. Tapping into the momentum of biologics requires investment but identifying the right areas to invest in is a challenge in an evolving market.

Production 98

Production Life Science Development Gene Therapy 98

pharmaphorum

NOVEMBER 22, 2022

The Helicons are taken into cells using endocytic trafficking, a process which sees the compounds packaged into folds in the plasma membrane, forming vesicles that are then internalised.

Gene Expression 52

Gene Expression Packaging Packaging Medicine 52

pharmaphorum

MARCH 3, 2022

The investment package includes £200 million ($268 million) to enable researchers to better access NHS data through what the government calls Trusted Research Environments and digital clinical trial services.

Manufacturing 52

Manufacturing Life Science Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch.

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

Contract Packaging 130

Contract Packaging Packaging Packaging Development 130

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Compliance 104