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Aseptic in Biological Technology

CEL-SCI Corporation to Launch Aseptic Filling for Stem Cell Produced Therapies and Other Biological Products

... for the process known as cold 4 degrees Celsius aseptic Filling on a contract basis to stem cell and ... allow CEL-SCI to perform cold 4 degrees Celsius aseptic filling of small volume parenteral drug products ... process and storage. CEL-SCI's unique, cold aseptic filling suite can be operated at temperatures ...

White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

... and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract ... the contractor's knowledge of formulation and aseptic manufacturing to develop the most appropriate ...

White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes

... The informative white paper, "Selecting An aseptic Fill/Finish Contract Manufacturer: Avoiding the ... a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product. The white ...

Baxter to Launch GARDian(TM), a Groundbreaking Initiative That Helps Provide Continued Access to GAMMAGARD for Current Patients

... antiglobulin reaction and, rarely, hemolysis. aseptic meningitis syndrome (AMS) has been reported to ... the Creutzfeldt-Jakob disease (CJD) agent. aseptic meningitis syndrome (AMS) has been reported to ... the Creutzfeldt-Jakob disease (CJD) agent. aseptic meningitis syndrome (AMS) has been reported to ...

PacificGMP and USC to Collaborate on Recombinant Protein Development and Manufacturing for Phase 1 Clinical Trial

... development, cGMP (current good manufacturing practices) manufacturing and aseptic fill and finish of purified human recombinant type VII collagen. The ... purification and scale-up, to preclinical and clinical manufacturing, aseptic filling, testing, analytical services and regulatory support. More ...

CEL-SCI Corporation Releases Letter to Shareholders

... stem cell-derived products and biosimilars. Our 4 degree Centigrade cold aseptic fill will be offered to the industry as a contract service. I leave you ... a refrigerator or freezer? We believe that the 4 degree Centigrade cold aseptic fill has the same kind of impact on the pharmaceutical/biotechnology drug ...

Microtest Labs Expands Clean Room, Contamination Testing Services

... clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators and fume hoods. HEPA filter ... clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators and fume hoods. Viable ...

Baxa Corporation Features PadLock(R) Set Saver at the ANCC National Magnet Conference(TM)

... the ANCC National Magnet Conference, October 15-17, in Salt Lake City. An aseptic IV administration set storage solution, PadLock provides a secure seal for ... The innovative PadLock Set Saver is designed to foster best practice for aseptic IV administration set maintenance, preventing touch contamination and ...

Hyaluron Contract Manufacturing Named a 2007 Economic Impact Award Finalist

... -- Hyaluron Contract Manufacturing (HCM), a leading provider of aseptic manufacturing services to companies in the pharmaceutical and ... About HCM: Hyaluron Contract Manufacturing (HCM) is a leader in aseptic contract manufacturing of filled liquid parenterals and medical devices. ...

Baxa Announces 2008 Dates for STAR Center Professional Pharmacy and Cleanroom Training

... to regulatory requirements. Class dates for the Compliance Tools and aseptic Certification for USP Course are being announced now because classes ... Englewood, Colorado. The center was purpose-built to support training in aseptic technique, pharmacy workflow and practice, cleanroom design and ...

Laureate Pharma Appoints Daniel E. Leone as Vice President of Business Development

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

Stem Cell Cord Blood 'Banking' Is Huge Global Business for Hospitals, Says CEO of Bio-Matrix Scientific Group Inc.

... company headquartered in San Diego, Ca. with a 15,000 sq. ft. facility that houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular/tissue class 10,000/100 processing lab, hematology, microbiology and flow cytometry laboratories. Disclaimer This news release ...

CEL-SCI Signs Definitive Agreement to Raise $5 Million in Registered Direct Offering

... technology platform and expects to soon finish the validation of its state-of-the-art facility in Maryland which it expects to utilize to launch aseptic filling for stem cell produced therapies and other biological products. The Company has operations in Vienna, Virginia, and Baltimore, Maryland. ...

Microtest Laboratories is an Industry Leader in ICH Stability Testing

... hazards in transit between tests." Microtest is widely recognized for its problem-solving expertise in pharmaceutical contract manufacturing, aseptic processing, and pharmaceutical packaging. Services include single-source production and testing, plus dedicated product management. For more ...

'Adipose-derived' Stem Cells Could Help Traumatic Brain Injury Patients, Says Bio-Matrix Scientific Group's, Entest BioMedical Inc. Researcher

... and development company with a new 15,000 square foot facility that houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular-tissue class 10,000/100 processing lab, hematology, microbiology, and flow cytometry laboratories. About Entest BioMedical Inc.: ...

Bio-Matrix Scientific Group, Inc. Announces Preferred Stock Dividend and Spinoff of Wholly-Owned Subsidiary, Entest Biomedical, Inc.

... in San Diego, California with a 15,000 square foot facility that houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular/tissue class 10,000/100 processing lab, hematology, microbiology and flow cytometry laboratories. Disclaimer: This news release ...

NIH News Confirms Trend in Stem Cell 'Storage' Facilities, says CEO of San Diego-based Bio-Matrix Scientific Group

... headquartered in San Diego, Ca. with a 15,000 square foot facility that houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular/tissue class 10,000/100 processing lab, hematology, microbiology and flow cytometry laboratories. The company also commercializes medical ...

Bio-Matrix Scientific Group CEO Tells Wall Street Transcript That 'Positive Cash Flow' Is Possible in '09; New Stem Cell Banking Facility Is Growth Vehicle Over the Next Two Years, Says CEO in Exclusive News Interview

... worldwide stem cell research market. Its new 15,000 square foot facility houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular/tissue class 10,000/100 processing lab, hematology, microbiology and flow cytometry laboratories. Disclaimer This news release may ...

Bio-Matrix Scientific Group, Inc. Highlighted in LifeSciencesWorld.com Special Report; Stem Cell Market Projected to Exceed $8 Billion Worldwide by 2016

... for the growing worldwide stem cell research market. Its new facility houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular/tissue class 10,000/100 processing lab, hematology, microbiology and flow cytometry laboratories. Disclaimer This news release may ...

Bio-Matrix Scientific Group Featured as 'Stock Pick' in Oakley's Column on WallStreetCorner.com

... for the growing worldwide stem cell research market. Its new facility houses two secure cryogenic stem cell banks, three research laboratories, aseptic cellular/tissue class 10,000/100 processing lab, hematology, microbiology and flow cytometry laboratories. ...

PacificGMP and LigoCyte Pharmaceuticals Announce cGMP Manufacturing Collaboration

... services from cell line optimization, early process design, development, purification and scale-up, to preclinical and clinical manufacturing, aseptic filling, testing, analytical services and regulatory support. More information can be found by visiting the Company's web site at www.PacificGMP.com ...

MODA Offers Paperless QC Micro Webinar Series on Automating Environmental Monitoring, Utility and Product Testing

... Particle Counting Division of Hach Company. With increased production demands of modern therapies--vaccines, injected drugs, human tissue--more aseptic processing conditions are required so that manufacturing facilities can ensure potential viable and non-viable contamination are under control. The ...

Health Robotics Announces Results of the European Union-Sponsored SafeChemo Project

... labeling and software reliability. CytoCare(TM) is still the best in the world, there's nothing to beat it. CytoCare(TM) creates a beautiful aseptic environment, free of microorganisms and particles. Other robots push-and-pull or suck-and-blow, CytoCare(TM) represents a far greater level of ...

Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients

... IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted ...

Baxa Features Rapid-Fill(TM) Colored Labels, PACT(TM) Products, Exacta-Mix(TM) 2400 Compounders and Abacus(TM) Software at the ASHP Mid-Year Clinical Meeting

... pharmacy and training facility located at the Baxa world headquarters in Englewood, Colorado. The center was purpose-built to support training in aseptic technique, pharmacy workflow and practice, cleanroom design and maintenance, and USP < 797 > compliance among other topics. Classes are taught ...

Laureate Pharma Honored as Emerging Life Sciences Company of the Year

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

PacificGMP and Actinium Pharmaceuticals Announce Agreements for cGMP Antibody Manufacturing and Stability Testing

... of cGMP and non-GMP services from cell line optimization, early process design, development and scale-up, to preclinical, clinical manufacturing, aseptic filling, testing, analytical services and regulatory support. More information can be found by visiting the Company's web site at www.PacificGMP.com ...

Laureate Pharma Announces Agreement with Tolera Therapeutics, Inc.

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

Laureate Announces Manufacturing Agreement with Tolerx

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

Althea Technologies Appoints Dr. Shabbir Anik as Chief Executive Officer

... new genomic information. Althea's services include cGMP contract manufacturing of recombinant proteins, DNA-based therapeutics and vaccines, and aseptic filling. For more information, visit http://www.altheatech.com . ...

Grifols Breaks Ground on New IVIG Facility

... and additional production and testing facilities. Earlier this year the Company obtained FDA approval of its state of the art bulk processing and aseptic filling facility at its Los Angeles manufacturing complex. About Grifols Grifols SA (Grifols) is a global healthcare company founded in 1940 ...

Laureate Pharma to Add More Manufacturing Capacity

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

DSM Biologics and MorphoSys AG to Manufacture Fully Human Antibody

... and proteins, formulation development, Clinical trial manufacturing and finished dose form manufacturing of solids, semi-solids, and scheduled drugs, aseptic liquid and lyophilized products. DSM - the Life Sciences and Materials Sciences Company DSM creates innovative products and services in Life ...

Study Suggests GAMMAGARD LIQUID May Target the Primary Pathway Involved in Alzheimer's Disease

... immobilization. IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis. aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted ...

Laureate Pharma Announces Manufacturing Agreement With Alopexx Pharmaceuticals, LLC

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

Laureate Pharma Reports Record Growth for 2007

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

Lambert, Edwards & Associates Named Agency of Record for The West Michigan Science & Technology Initiative

... projects to build a strong base of intellectual property in west Michigan, as well as the creation of businesses, such as ClinXus(TM) and Grand River aseptic Pharmaceutical Packaging that build regional life sciences commercialization infrastructure. About Lambert, Edwards & Associates Lambert, Edwards ...

HCM Announces Substantial Growth in 2007

... was employed by ACI Worldwide (formerly P&H Solutions) as Vice President and Corporate Counsel. Located in Burlington, MA, HCM has been offering aseptic formulation and filling services to biotechnology and pharmaceutical companies. At the core of HCM's business is a commitment to quality, regulatory ...

Laureate Pharma Appoints Gary Swan as Vice President of Operations

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...

Laureate Announces Manufacturing Agreement with ARIUS for Trop-2 Targeting Antibody

... production. Laureate provides a wide range of specialized services from process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services, and regulatory support. Laureate is focused on two active segments of the biopharmaceutical ...
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