Lyophilization News and Research

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Freeze-drying, also referred to as lyophilization, is a process that involves freezing a substance at very low temperatures and then extracting liquid via sublimation, converting water from a solid to gaseous state.

LSNE's Harvey Road facility receives approval to manufacture drug product for US distribution

Lyophilization Services of New England, Inc. announced today that following an FDA Pre-Approval Inspection (PAI) in November 2014, their Harvey Road manufacturing site has received approval to manufacture commercial drug product for US distribution.

7 Jan 2015

New pediatric heart-defect patches enhance electrical connections between cells

Carbon nanotubes serve as bridges that allow electrical signals to pass unhindered through new pediatric heart-defect patches invented at Rice University and Texas Children's Hospital.

24 Sep 2014

USPTO issues three new patents to Discovery Laboratories

Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that the United States Patent and Trademark Office (USPTO) has issued a new patent and Notices of Allowance for patents covering critical aspects of its KL4 surfactant and drug delivery technology platform.

7 May 2014

FDA completes inspection of LSNE's medical device manufacturing facility in Manchester

Lyophilization Services of New England, a New Hampshire based contract manufacturing organization is pleased to announce that the Food and Drug Administration recently completed an inspection of their Manchester manufacturing facility.

8 Jan 2014

Habitual dietary intake of monozygotic twins associated with fecal microbiota composition

The establishment of microbial populations in the gastrointestinal-tract is a complex process, involving microbial and host interactions eventually resulting in a dense and stable population.

18 Nov 2013

adaptiQ™ system for ready-to-use pharmaceutical vials launched by SCHOTT

SCHOTT introduced its adaptiQ™ system for ready-to-use pharmaceutical vials, which allows for more flexible manufacturing concepts and more efficient filling. Designed in close collaboration with filling line manufacturers to meet the pharmaceutical industry’s process requirements, SCHOTT adaptiQ consists of a patented nest that securely holds as many as 100 clean and sterile vials in an industry standard tub.

12 Nov 2013

FDA grants Cook Pharmica first commercial manufacturing approval

In a decision that paves the way for greater pharmaceutical industry use of the company's contract manufacturing services, Cook Pharmica LLC has received its first approval from the U.S. Food and Drug Administration (FDA) to manufacture commercial product.

18 Jun 2012

Arte, ProJect Pharmaceutics partner to develop Lyo-DCPS

Arte Corporation and ProJect Pharmaceutics have been working closely on the development of a new type of dual chamber prefillable syringe for freeze-dried pharmaceuticals. The two companies have joined together with the objective to provide innovative dual chamber syringes for the global pharmaceutical market.

6 Jun 2012

Investigators describe how they synthesized polymers to stabilize proteins

Proteins are widely used as drugs - insulin for diabetics is the best known example - and as reagents in research laboratories, but they react poorly to fluctuations in temperature and are known to degrade in storage.

22 May 2012

Soligenix first quarter revenues decrease to $647,418

Soligenix, Inc., a development stage biopharmaceutical company, announced today its financial results for the quarter ending March 31, 2012.

14 May 2012

Biological scaffold for heart valves can be freeze-dried for later use

The biological scaffold that gives structure to a heart valve after its cellular material has been removed can be freeze-dried and stored for later use as a tissue-engineered replacement valve to treat a failing heart, as described in an article in Tissue Engineering, Part C: Methods, a peer-reviewed journal from Mary Ann Liebert, Inc..

15 Feb 2012

Soligenix reports positive results from preclinical studies of vaccine thermostabilization technology

Soligenix, Inc., a development stage biopharmaceutical company, announced today results from preclinical studies of its proprietary vaccine thermostabilization technology indicating that Soligenix is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions.

6 Feb 2012

Low temperature vacuum drying process for production of probiotics

Probiotic bacteria are rapidly gaining ground as healthy food supplements. However, the production of this "functional food" has its pitfalls: only few probiotic bacterial strains are robust enough to survive conventional production processes.

7 Jul 2011

ETI finalizes proprietary progesterone formulations for Traumatic Brain Injury

Encore Therapeutics, Inc. today reported finalizing its proprietary phospholipid nanoemulsion formulation of progesterone.

12 May 2011

BioSpecifics 2010 net loss decreases to $1.5 million

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the fourth quarter and full year ended December 31, 2010.

11 Mar 2011

Combined diagnosis and treatment of tumors: photothermically activated ultrasound contrast agent

Diagnosis and treatment form the basis of modern medicine. Traditionally, they are two separate steps; however, it doesn’t have to be that way. The term “theranostic” refers to the combination of a diagnostic test with a specific treatment based on the result of the test. This integrated approach should be particularly helpful in providing more targeted treatment for cancer patients.

1 Mar 2011

TriLink signs licensing agreement to use CleanAmp dNTPs in Biofortuna's PCR kits

TriLink BioTechnologies, Inc. announced that it has signed a licensing agreement with Biofortuna Ltd. (Biofortuna) for use of CleanAmp dNTPs in Biofortuna's freeze dried in vitro diagnostic PCR kits.

15 Sep 2010

Advaxis, Vibalogics to develop storage-stable formulation for live Listeria vaccines

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company and Vibalogics GmbH, a German biologics manufacturing company, have agreed to co-develop a room temperature stable, processing technology for live vaccines originally engineered for Advaxis.

12 Aug 2010

LLC to provide contract drug development services

LyoTechnica, LLC has announced that it has been established to provide contract drug development services for injectable pharmaceuticals. The company and its affiliates bring over 80 years of combined experience in lyophilization and liquid dosage form development as well as over 100 years experience in commercial scale manufacturing of parenteral drugs. The company offers analytical and formulation development, manufacturing of sterile stability batches and stability testing services.

16 Jul 2010

Cepheid denies Abaxis' allegations of patent infringement, files answer and counterclaims

Cepheid announced today that it has filed an answer and counterclaims in a patent suit brought by Abaxis on June 28, 2010 in the United States District Court for the Northern District of California. In its filing, Cepheid denied Abaxis' allegations of patent infringement, asked the Court to determine it has paid all royalties due and is in full compliance with all the terms of its license, and to find that Abaxis' patents are invalid.

13 Jul 2010