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

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

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

RNA 147

RNA Vaccine Vaccination In-Vivo 147

Pharmaceutical Technology

APRIL 11, 2023

The Phase III ENDEAVOUR study, which is part of the SRP-9001’s BLA package, used a primary endpoint centered on measuring micro-dystrophin expression, a surrogate marker that has been used in the regulatory approvals for exon-skipping therapies.

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

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

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 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.”.

Packaging 130

Packaging Packaging Production Containment 130

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.

Production 169

Production Gene Therapy Packaging Packaging 169

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

STAT News

NOVEMBER 4, 2022

One aspect of the therapy that was not entirely new was the use of engineered viruses to deliver instructions for the gene editing therapy into Terry’s cells. Like many gene therapy companies, Cure Rare Disease packaged the therapy in adeno-associated viruses.

Gene Editing 105

Gene Editing Gene Gene Therapy Scientist 105

The Pharma Data

MAY 26, 2023

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities.

Clinical Supply 52

Clinical Supply Gene Therapy Gene Development 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

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.

Life Science 130

Life Science Manufacturing Contract Manufacturing Gene Therapy 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 Doctors Doctor 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

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

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

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.

Development 130

Development Production Manufacturing Vaccine 130

The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

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

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

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

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 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

XTalks

FEBRUARY 10, 2023

“At Medpace, we go further by having a specialist regulatory technical team support our clinical trials, particularly for cell-therapy studies.” Holton identified the following key strategies to help overcome the operational challenges of cell therapy clinical trials: Execute a manufacturing feasibility study. If so, why?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

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

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

The Pharma Data

NOVEMBER 22, 2020

Pfizer has designed its own packaging using dry ice that can be stored for weeks without the specialized freezers. Distributing the vaccine under ultra-cold chain storage conditions, she said, “is possible, but it’s definitely going to be much more expensive and more difficult.”. Featured Jobs on BioSpace. Source link.

Vaccine 52

Vaccine Vaccination Protein Genetics 52

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. 1] BioNews. Hemophilia News Today. link] [2] Tang Q, et al.

Genomics 244

Genomics Genome Medicine Gene Therapy 244

Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

FDA Law Blog

SEPTEMBER 20, 2021

We have seen first-hand the difficult task faced by CBER review staff to keep up with the flood of innovative cell and gene therapy products, as well as the taxing influx of COVID-19 pandemic related applications requiring review resources in both Centers.

Development 52

Development Gene Therapy Production Drugs 52

STAT News

MARCH 21, 2023

Food and Drug Administration official says the agency needs to start using accelerated approval, a much-debated path commonly used for advancing cancer drugs, to advance gene therapies for rare diseases, STAT reports. This is the first time the agency will consider using an accelerated approval for gene therapy.

Gene Therapy 98

Gene Therapy Gene Packaging Packaging 98

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 for a 2-pen package (0.6

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

AUGUST 3, 2021

We are very pleased that our comprehensive nonclinical data package has addressed all issues identified related to DRG toxicity and the FDA has reached the decision that we may proceed with our OAV-101 IT clinical trial program and initiate the STEER trial,” said Shephard Mpofu, M.D., SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Gene 52