Recombinant Protein Production News and Research

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Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today it has received approval from the Food and Drug Administration to proceed with the first human clinical trial of plant-produced H5N1 influenza vaccine.

6 Dec 2010

Science and precedent do not support biosimilar approach for plasma protein therapies

The current science and experience does not support the safety and efficaciousness of a biosimilar pathway for plasma protein therapies. At a public hearing last week, the Plasma Protein Therapeutics Association (PPTA) urged the United States Food and Drug Administration (FDA) to make patient safety its top priority by adopting a global approach in its evaluation of plasma protein therapies for the biosimilars process.

15 Nov 2010

FDA accepts IND application for vaccine candidate based on iBioLaunch technology platform

iBio, Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application filed for a vaccine candidate made with the Company's proprietary transformative technology, the iBioLaunch technology platform. The candidate vaccine was manufactured by iBio's research collaborator, Fraunhofer Center for Molecular Biotechnology (FCMB), in its cGMP pilot manufacturing facility in Newark, Delaware.

21 Sep 2010

CMB initiates first human trial for plant-produced H1N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology (CMB) announced today it has initiated the first human trial of plant-produced H1N1 influenza vaccine at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC).

18 Sep 2010

Life Technologies finalizes cell line license agreement for recombinant protein production

Life Technologies Corporation today announced that it has finalized cell line license agreements with a number of companies to provide rights to Life Technologies' proprietary CHO (Chinese hamster ovary) cell lines for the production of recombinant proteins used as therapeutic agents and vaccines.

14 Sep 2010

Edimer Pharmaceuticals, CMC Biologics execute manufacturing contract to develop EDI200 recombinant protein

Edimer Pharmaceuticals and CMC Biologics today announce the execution of a manufacturing contract to support the development of EDI200, a clinical-stage recombinant protein for the treatment of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), a rare genetic disease with orphan designation in the USA and Europe.

10 Sep 2010

BioMimetic completes 100 day PMA meeting with FDA for Augment Bone Graft

BioMimetic Therapeutics, Inc. today announced it completed its 100 day Premarket Approval Application (PMA) meeting with the Food and Drug Administration (FDA) regarding the review of Augment™ Bone Graft for the treatment of foot and ankle fusions in the U.S. The FDA generally meets with the PMA sponsor approximately 100 days after the filing of the PMA with the purpose of discussing the status of the application.

9 Sep 2010

ForteBio launches Protein G biosensor for rapid detection of mammalian IgGs

ForteBio®, Inc., a leading supplier of label-free technology that accelerates the development of biotherapeutic and pharmaceutical products, today announced the launch of its Dip and Read™ Protein G biosensor for rapid detection and quantification of numerous types of mammalian immunoglobulin (IgG), an antibody molecule, from solution. Because it runs on the company's label-free Octet instrumentation platform, the new biosensor enables such measurements with unprecedented speed, ease of use and cost-efficiency.

3 Sep 2010

BAC, Octapharma enter licence agreement for G-CSF CaptureSelect custom affinity ligand

BAC BV, the leading provider of antibody-based affinity purification technology, today announced that it has entered into a licence agreement with Octapharma (Lachen, Switzerland), an independent, global provider of human proteins for life-threatening diseases.

17 Aug 2010

Study identifies options for restoring knee cartilage lubrication to prevent OA

An injury to the anterior cruciate ligament is fairly common, especially among young athletes. While it can often be corrected through surgery, the injury can lead to increased risk of developing degenerative joint diseases, including osteoarthritis. The problem is that fluid in the knee joint, which lubricates the cartilage, is impacted by the trauma of the injury and begins to deteriorate.

6 Aug 2010

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep (Novasep), a leading supplier of manufacturing solutions to the life sciences industries, announce today that they have received French Government funding through OSEO to finance the development of CER-001, a Cerenis HDL mimetic.

26 Jul 2010

HZI researchers develop new method to produce insulin for treatment of diabetes

More than eight million diabetics live in Germany. Diabetes is not restricted to our prosperous society and the highest growth rates often occur in countries with aspiring economies such as in Asia. Worldwide, more than 285 million people suffer from this illness; with 50 million diabetics, India is the country with the most people affected by this disease.

27 May 2010

KTH Royal Institute of Technology Stockholm, BioSilta Oy collaborate to optimise protein screening

KTH Royal Institute of Technology Stockholm and Biotechnology start-up BioSilta Oy of Oulu Finland have been collaborating over the last year to optimise protein screening in a range of microwell plate formats. The technique utilises EnBase Flo the newly developed Enzymatic Release media technology from BioSilta.

18 May 2010

Protein Potential receives Phase II SBIR Grant to develop vaccine for prevention of P. vivax infections

Protein Potential LLC has received support from the National Institute of Allergy and Infectious Diseases of the NIH in the form of a Phase II Small Business Innovation Research Grant. The three-year award totaling approximately $3 million will support translational research to develop a vaccine for the prevention of malaria caused by the parasite Plasmodium vivax.

19 Apr 2010

EUREKA project develops unique range of antibodies

EUREKA project E! 3424 RECAN has developed a range of unique and highly specific monoclonal and polyclonal antibodies - the proteins produced in the blood which counteract bacteria, viruses or cancerous cells.

20 Mar 2010

Fraunhofer USA CMB receives $4.395M award from DARPA to develop H1N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today that it has received a $4.395 million award from the Defense Advanced Research Projects Agency to develop a vaccine against H1N1 influenza virus using its plant-based production platform.

16 Mar 2010

Halozyme Therapeutics reports net loss of $12.7M for fourth-quarter of 2009

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the fourth quarter and year ended December 31, 2009.

12 Mar 2010

AMT initiates dosing in Phase I/II gene therapy clinical trial for hemophilia B

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the first patient has been dosed in the Phase I/II exploratory clinical trial with a gene therapy product for hemophilia B, a seriously debilitating and potentially lethal disease.

10 Mar 2010

Growing human therapeutic proteins in algae can help reduce cancer treatment cost

Pharmaceutical companies could substantially reduce the expense of costly treatments for cancer and other diseases produced from mammalian or bacterial cells by growing these human therapeutic proteins in algae-rapidly growing aquatic plant cells that have recently gained attention for their ability to produce biofuels.

9 Mar 2010

Study shows CEL-2000 vaccine blocks RA progression in mice

CEL-SCI Corporation and their scientific collaborators announced today that the Company's CEL-2000 vaccine demonstrated that it is able to block the progression of rheumatoid arthritis (RA) in a mouse model.

23 Feb 2010