Navigation Links
Cutting-edge approaches to ensuring biologic drug quality focus of forum on bioassays
Date:11/16/2012

Rockville, Md., November 16, 2012 As a growing number of biologic drugs are treatments of choice for an expanding list of autoimmune disorders, inflammatory diseases, and certain cancers, bioassays play a critical role in establishing the functional integrity and potency of these products. Hosted by the United States Pharmacopeial Convention (USP), the Fifth Bioassay Workshop will take place on December 4-5, 2012, at USP's headquarters in Rockville, Md. The workshop will focus on the development, monitoring and validation/revalidation of bioassays. It will feature perspectives from manufacturers, regulators and other stakeholders on such topics as the replacement of animal-based assays with cell-based assays; USP's standards for bioassays; software selection for bioassay development and other related topics.

According to Roger L. Williams, M.D., chief executive officer of USP, "Developing standards for modern medicines such as biologics is a complicated yet important undertaking. Through forums like USP's Fifth Bioassay Workshop, manufacturers, regulators and other stakeholders can exchange ideas and strategies for approaching important issues such as bioassay development. Being able to share information and expertise undergirds our ability to create standards that help to ensure the quality of the global drug supply."

Conventional pharmaceuticals are made through chemical routes and have small molecular structures. Biologicsparticularly more modern ones such as recombinant proteins and monoclonal antibodiesare larger and more complex in their makeup, and are derived from living cells or organisms. As a result, it is not possible to fully characterize biologic drugs in the same way that chemical drugs are characterized using commonly-applied analytical techniques and procedures. Bioassays are used to assign or confirm drug potency and to validate that a drug is functioning as expected, usually by comparison to a known reference standard. Sinc
'/>"/>

Contact: Theresa Laranang-Mutlu
trl@usp.org
301-816-8167
US Pharmacopeia
Source:Eurekalert

Page: 1 2 3

Related medicine news :

1. More cutting-edge cancer research supported by industry
2. AGA presents cutting-edge research during DDW®
3. ASHA grant funds cutting-edge AIDS research at Tel Aviv University
4. New national clinical trials network for neurological disorders to foster cutting-edge treatments
5. Scripps Florida scientists awarded nearly $1.5 million to develop new approaches to treat cancer
6. GWU consensus report outlines new approaches for evaluating benefits and risks of obesity drugs
7. NIH awards $7.8 million for innovative HIV vaccine approaches
8. As painkiller overdoses mount, researchers outline effective approaches to curb epidemic
9. Control of disease activity and biologic treatment increase life expectency in RA patients
10. Personalizing biologic treatment to individual patients with rheuatoid arthritis is cost-effective
11. Study Compares Safety of Biologic Meds for Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/1/2015)... ... September 01, 2015 , ... ... exclusively to funding innovative lymphoma research and serving the lymphoma community through a ... its annual Light it Red for Lymphoma awareness initiative, the nation’s premier and ...
(Date:9/1/2015)... ... ... From Aug. 17-21, Calvary Hospital hosted the 18th consecutive session of its ... taken place at Kingsborough Community College in Brooklyn in each of the past three ... and two junior counselors who were campers themselves just a few years ago. , ...
(Date:9/1/2015)... ... September 01, 2015 , ... Georgia State University ... across the country in stemming sexual assaults on their campuses. , The free, ... consortium of sexual assault researchers and student affairs professionals responding to calls by ...
(Date:9/1/2015)... ... September 01, 2015 , ... As part ... and Blue Shield of Minnesota (Blue Cross) has announced Doctor On Demand as ... San Francisco, Doctor On Demand provides immediate access to Board Certified physicians or ...
(Date:9/1/2015)... Fairfax, VA (PRWEB) , ... September 01, 2015 ... ... the Mane Vendor “Hair Extension Vending Machine,” is still strongly maintaining her firm’s ... modern technology, and beauty tools. In her upcoming city-to-city tour, Ellis will be ...
Breaking Medicine News(10 mins):Health News:Lymphoma Research Foundation Recognizes National Blood Cancer Awareness Month with Light it Red for Lymphoma Campaign 2Health News:Lymphoma Research Foundation Recognizes National Blood Cancer Awareness Month with Light it Red for Lymphoma Campaign 3Health News:Calvary Hospital Hosts 18th Annual Bereavement Camp 2Health News:Calvary Hospital Hosts 18th Annual Bereavement Camp 3Health News:Georgia State, Partners Introduce Climate Survey to Aid in Preventing Campus Sexual Assaults 2Health News:Blue Cross and Blue Shield of Minnesota names Doctor On Demand as preferred telehealth destination 2Health News:Blue Cross and Blue Shield of Minnesota names Doctor On Demand as preferred telehealth destination 3Health News:Beauty Entrepreneur creates hair extension smart machine and mobile app inspired by UBER technology 2
... the Flexible-Fiber CO2 laser to safely cut and coagulate ... sight problems encountered with conventional CO2 lasers. The findings, ... Boston University School of Medicine (BUSM), appear in the ... the first study to report the utility of flexible-fiber ...
... August 16, 2011 Seattle Children,s Research Institute ... million grant from the Bill & Melinda Gates ... respiratory support device, called Seattle Children,s Positive Airway ... affordable and simple Bubble Continuous Positive Airway Pressure ...
... , TUESDAY, Aug. 16 (HealthDay News) -- Many women ... supplement that,s been recalled due to dangerous ingredients, a new ... and phenolphthalein, both of which are banned in the United ... and cancer. The U.S. Food and Drug Administration announced ...
... , MONDAY, Aug. 15 (HealthDay News) -- You ... new study suggests. Japanese researchers report that alcohol hinders ... study of 10 male university students, appear online and in ... & Experimental Research . Booze,s effect on sleep ...
... 2011 Updated public standards incorporating new tests for ... ensure the quality of over-the-counter (OTC) ingredients and products ... 8-9, 2011, workshop co-sponsored by the U.S. Food & ... In addition to providing updates on new ...
... HealthDay Reporter , MONDAY, Aug. 15 (HealthDay News) -- Psychologists ... that places a high value on defending one,s reputation at ... with high rates of accidental deaths. "People who embrace ... Ryan Brown, an associate professor of psychology at the University ...
Cached Medicine News:Health News:Study finds flexible-fiber CO2 laser safe in endoscopic endonasal transsphenoidal surgery 2Health News:Seattle Children's lands major funding with hopes of saving thousands of infant lives 2Health News:Seattle Children's lands major funding with hopes of saving thousands of infant lives 3Health News:U.S. Women Using Dangerous Weight-Loss Pill 2 Years After Recall 2Health News:More Evidence That Alcohol Hinders Good Sleep 2Health News:FDA-USP workshop to preview updated OTC standards 2Health News:FDA-USP workshop to preview updated OTC standards 3Health News:For Men, 'Culture of Honor' Can Be Deadly 2Health News:For Men, 'Culture of Honor' Can Be Deadly 3
(Date:9/1/2015)... 1, 2015 Ardelyx, Inc. (NASDAQ: ... gastrointestinal and cardio-renal diseases, today announced that Sanofi ... and license agreement for Ardelyx,s portfolio of NaP2b ... payment associated with termination and the return of ... Sanofi entered into an option and license agreement ...
(Date:9/1/2015)... Sept. 1, 2015  Dynatronics Corporation (NASDAQ: ... at the First Annual Ladenburg Thalmann Healthcare Conference ... Kelvyn H. Cullimore, Jr. , Chairman and ... investment representatives on Tuesday, September 29 at 10:30 ... Conference will showcase leading-edge companies in the healthcare ...
(Date:9/1/2015)... -- Dr. Cindy Orser , the Chief Science Officer ... of DigiPath, Inc. (OTCQB: DIGP), was recently interviewed ... consistency in today,s medical cannabis testing industry. In her ... she explained that the state-to-state variations in cannabis laws ... makes standardization impossible. Dr. Orser is ...
Breaking Medicine Technology:Ardelyx Regains NaP2b Program from Sanofi 2Ardelyx Regains NaP2b Program from Sanofi 3DigiPath Labs CSO Dr. Cindy Orser Calls for Uniform Standards for Cannabis Safety Testing 2DigiPath Labs CSO Dr. Cindy Orser Calls for Uniform Standards for Cannabis Safety Testing 3
... China , April 29 /PRNewswire-Asia-FirstCall/ -- China Pharma,Holdings, Inc. (NYSE ... pharmaceuticals company in China , today announced,that it has retained CCG ... , , ... to working with CCG to establish more effective and,transparent communications channels with ...
... , April 29 Royal Philips Electronics ( ... provider of integration solutions in healthcare, to deploy the Orion Health Rhapsody® ... , , ... , , ...
Cached Medicine Technology:China Pharma Holdings, Inc. Retains CCG Investor Relations 2China Pharma Holdings, Inc. Retains CCG Investor Relations 3China Pharma Holdings, Inc. Retains CCG Investor Relations 4China Pharma Holdings, Inc. Retains CCG Investor Relations 5Philips and Orion Health Partner to Deliver on Enterprise Interoperability 2Philips and Orion Health Partner to Deliver on Enterprise Interoperability 3Philips and Orion Health Partner to Deliver on Enterprise Interoperability 4
The Rheumatoid Factor (RF) assay is used for the quantitative analysis of rheumatoid factor in human serum....
Rheumatoid Factor , R1: 4 X 20 ml buffer, R2: 2 X 8 ml antibody, Test / Kit: 320 (H717)...
EXTEND is an absorbable synthetic punctal implant that provides occlusion up to three months. It is packaged 20 implants per box in sizes of .0.3mm, 0.4mm, 0.5mm. A variety pack in also available w...
... The Carriazo-Pendular microkeratome is based ... of the cornea during the cut., ... applanated evenly from the beginning of ... ensures that the intraocular pressure does ...
Medicine Products: