Roots Analysis

AUGUST 29, 2023

Raw materials used for the production of cell therapies include culture media, growth factors, extracellular matrices and reagents. Types of Cell Therapy Consumables Raw materials used in the manufacturing of cell therapies can be classified as buffers, cell culture media, growth factors, kits, reagents and extracellular matrices.

Reagent 52

Reagent Manufacturing Production Containment 52

XTalks

JANUARY 21, 2025

In a clinical trial, participants demonstrated a 98% success rate after six months post implantation, with arteries widened successfully and no stent fractures observed. The Onclarity HPV reagent pack extraction combo. Once in place, it acts as a scaffold, restoring proper blood flow. Photo courtesy of BD.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Camargo

MAY 2, 2021

CMC: Innovative technologies, product manufacturing, reagents, starting materials, critical product components, novel delivery device qualification, and complex software issues. Scope and design of definitive animal trials and clinical trials. Identify critical development issues or deficiencies to address.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

pharmaphorum

SEPTEMBER 29, 2022

She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements.

Development 104

Development Regulation Production Life Science 104

pharmaphorum

FEBRUARY 3, 2021

While achieving the Nobel Prize spotlight would have been enough to impress, CRISPR-Cas9 gene editing is part of a growing list of technologies granted Investigational New Drug (IND) applications with early data from clinical trials supporting its safe use in edited cells re-introduced into a patient.

Gene Editing 98

Gene Editing Gene DNA Engineer 98

pharmaphorum

JANUARY 25, 2022

The Toronto-based company already counts many of the world’s largest pharma companies among its customers, using its platform for a range of tasks such as improving reagent and antibody selection to help scientists run more successful experiments, drawing on data from published studies and organisations’ internal databases.

Life Science 52

Life Science Reagent Pharma Companies Scientist 52

The Pharma Data

MAY 17, 2021

Now these entities are being increasingly sought out to develop these therapies as more applications are being explored, especially with the “groundbreaking results” of these trials in the oncology areas. . With this explosive growth, “the need for clinical testing and application facilities is growing steadily,” said Uharek. .

Development 52

Development Gene Therapy Manufacturing Gene 52

pharmaphorum

DECEMBER 16, 2022

Clinical trials technology company Saama has hired Dr Clinton White as its new chief delivery officer. Drawing on 25 years in clinical research, White will oversee Saama’s project delivery teams. Pharmaceutical supplier PBSC has tapped Jose Ruiz as the new president and general manager for its US office.

Behavioural Health 52

Behavioural Health Reagent Gene Therapy Production 52

Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. But review issues are not the only problems.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

The designation of lanifibranor as a Breakthrough Therapy for the treatment of NASH follows the publication in June 2020 of positive topline results from Inventiva’s NATIVE Phase IIb clinical trial with lanifibranor in NASH patients. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing In-Vivo 52

The Pharma Data

OCTOBER 19, 2020

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. Please read more here. .

Vaccine 52

Vaccine Vaccination Trials Clinical Trials 52

pharmaphorum

JUNE 1, 2021

This technology can also play an important role in supporting virtual clinical trials. The FDA has stated that when microtaggants are pharmaceutically inactive and incorporated into new or existing drugs, they can be treated as excipients without the need for further clinical trials.

Medicine 52

Medicine DNA Pharmacy Production 52

The Pharma Data

DECEMBER 23, 2020

The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.

Drugs 52

Drugs Licensing Licensing Vaccination 52

The Pharma Data

MAY 15, 2023

She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company. Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company. Nor can there be any guarantee that such products will be commercially successful in the future.

Sales 40

Sales Production Doctors Doctor 40

XTalks

OCTOBER 1, 2020

The drug is currently in clinical trials for alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), as well as in COVID-19 patients with acute liver or kidney injury. Key Moments. Now she says that she completely appreciates the focus of industry. But in companies, you cannot do that.

Scientist 52

Scientist In-Vitro Research Life Science 52

XTalks

JANUARY 6, 2025

For example, antisense oligonucleotide (ASO)-based therapies have gained traction, with 100 Phase I clinical trials initiated and around 25 percent of these advancing to Phase II or Phase III trials in recent years. The global next-generation biomanufacturing market is projected to grow at a CAGR of 14.85 billion by 2031.

Gene Therapy 111

Gene Therapy RNA Gene Editing Gene 111