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Neo-Advent Technologies opens BioPharma&Chemical Materials Storage Suite
Littleton, MA, February 12, 2012 - Neo-Advent Technologies opens a Material Storage Suite that offers a cost-saving opportunity for the client’s reagents, raw materials, chemical intermediates and non-GMP lots of the preclinical drug candidates including an ambient (15-30oC) and low temperature (4oC) controlled storage, as well as -80oC freezers. Complementary to the standard storage services, the facility is uniquely integrated with a chemistry and analytical lab. Per clients requirement and schedule, the materials can be repacked, (re)labeled, sampled/analyzed, supported by designing and issuing a certificate of the analysis (COA) and shipped to the designated third parties. In-house analytical options include but not limited to residual moisture (Karl Fisher), FT-IR, metal analysis by AA, particle size analysis, thermal analysis (TGA, DSC), HPLC, LC-MS, GC-MS and head space analysis, optical microscopy, and ICH stability studies.
Neo-Advent exhibits at MassBIO 2012 Drug Development Symposium
Boston, MA, January 19, 2012 - Neo-Advent Technologies will exhibit at the “Accelerated Drug Development Symposium” organized by the Massachusetts Biotechnology Council CRO CMO Committee, to be held on March 6, 2012 at LaCava Conference Center, Bentley University:
www.massbio.org/events/calendar/1389-ma_cro_cmo_committee_symposium_accelerating_drug/event_detail
The goal of the symposium is to allow attendees to evaluate the best alternatives that have evolved in shortening time to market. A series of case studies, interactive panel discussions, and networking sessions will explore the various techniques and approaches being used by both virtual and established companies. The program includes case studies by start-ups early stage and large pharmaceutical companies doing breakthrough work in discovery, development, and manufacturing that are utilizing the valuable external resources provided by local CRO/CMO firms. An exhibition area will facilitate direct contact with companies providing a variety of services, from research to commercial manufacturing.
NAT launches Micronization XPRESS
Littleton, MA, December 12, 2011 - NAT launches the Micronization XPRESS, an accelerated development program to rapidly micronize the client’s API for enhanced solubility and bioavailability. Significant number of the drug development candidates display low solubility and bioavailability and thus present significant challenges in achieving desired therapeutic effects. Micronization allows for a dramatic increase of the API’s surface area and may lead to substantial improvements in pharmacological properties. The streamlined Micronization XPRESS program offered by NAT aims to quickly provide testing sample formulations for subsequent validation in the clients’ in vivo studies using small (1-5 g) quantities of the API that is often in short supply at the early stages of the preclinical development. Based on our extensive experience in the wet and dry milling, we developed a panel of highly effective approaches leading to a quick optimization of the milling conditions to low-micron or often sub-micron sized particles. The program is supported by a short-term stability study to confirm integrity of the API using HPLC or other methods provided by a client, or additionally helps to develop these methods. Critical features of our pioneering Micronization XPRESS program:
• Unparalleled speed with a 7-day completion time
• Delivery of a ready-for-testing formulation for in vivo studies
• Small amount of the API required for the full study
• API stability control
NAT and JAH Associates to Collaborate
Boston, April 14, 2011 - Neo-Advent Technologies, LLC, Littleton, MA and JAH Associates, LLC, Wayne, PA have entered into a strategic collaboration that will combine the expertise of both companies in offering a comprehensive panel of integrated services covering a wide range of pre-clinical drug and medical devices development tasks. Services comprise design and execution of complete preclinical development programs including medicinal chemistry, API scale-up, drug formulation, toxicology, and drug metabolism and pharmacokinetic studies with comprehensive in-house analytical and bio-analytical support. Additional expertise includes the formation of comprehensive regulatory strategies for pre-clinical and clinical development, protocol development, study placement and monitoring, report writing, reviews of preclinical programs, and preparation of regulatory documents, including Investigator Brochures and IND applications. JAH Associates’ Principal, Jeff Handler, said: “We are very pleased to begin collaboration with NAT who have built up an impressive lab operation capable of efficiently addressing, under the same roof, many practical issues in drug formulation, chemistry and analytical and bio-analytical support encountered on the drug and medical device development pathway where we previously needed multiple vendors of solutions and services.” NAT President Nelson Landrau said: “Jeff and his team brings an enormous value to the table with their hands-on experience in project management, toxicology, pharmacology, and regulatory aspects. Our clients will also gain significant benefits by creating and executing development plans that achieve their business goals rapidly and in a cost-effective manner.”
NAT Present at PITTCON 2011 in Atlanta
Boston, January 28, 2011 – Neo-Advent Technologies, LLC will be present at PITTCON 2011 in Atlanta, Booth No. 5158, to showcase its offerings in drug formulation and bioanalytical services alongside with over a thousand of companies participating in this major industry event. PITTCON is the world's largest annual conference and exposition for the laboratory science. It offers the latest technology and instrumentation, a diverse technical programs including presentations, posters, as well as a vast array of educational courses and networking sessions. This venue provides an opportunity to exchange innovative ideas for scientists from around the world.
NAT Filed a Patent Application on Novel Smart Hydrogels for Drug Delivery
Littleton, October 10, 2010 - Neo-Advent Technologies, LLC reached a major milestone in its program on development of polymer-based smart hydrogels that are responsive to the environmental stimulus such as temperature, ionic strength, pH, and other factors. The Company filed a provisional patent application regarding a proprietary method of introducing thiol groups into hyaluronic acid (HA). The thiolated HA precursors are low viscosity solutions stable at pH=3-4 that are easy to handle and apply. Gelation occurs with a pH adjustment to 7.0-7.4 in presence of oxygen from air that oxidizes thiol groups with a formation of the disulfide cross-links. The gelation time and properties of the gel can be exquisitely regulated by the thiol content, HA concentration, pH, and temperature. Developed technology avoids a byproduct formation, exothermic reactions and potential toxicity inherent to many hydrogel cross-linkers.
NAT Began Offering GLP-compliant Thermal Stability Studies
Littleton, September 5, 2010 - Neo-Advent Technologies, LLC extended to GLP compliant its service offering in thermal stability studies of the active pharmaceutical ingredients (APIs) and finished products. The Company provides protocol development, testing and evaluation under the variety of conditions following ICH guideline including controlled humidity, as well as custom cyclic conditions. The range of testing products involves APIs, tablets, topical, and parenteral formulations. Complemented by the wide range of the analytical quality control techniques including HPLC and LC/MS, the testing program can meet most stringent demands of the customers in a timely manner.
NAT Initiates Services Using a 4000 QTRAP LC/MS/MS System
Littleton, May 10, 2010 – Neo-Advent Technologies, LLC completed the installation of the AB SCIEX 4000 QTRAP·LC/MS/MS System, a state-of-the-art hybrid triple quadrupole/linear ion trap mass spectrometer, a powerful tool to further extend the range of NAT’s R&D capabilities and services into drug discovery and development, metabolite identification, contaminant testing, and proteomic applications including post-translationally modified proteins discovery, protein identification, and biomarker validation. The system will enable high-sensitivity full-scan MS, MS/MS, and MS3 with high-selectivity from true triple quadrupole precursor ion (PI) and neutral loss (NL) scans; perform multiple-reaction monitoring (MRM) for quantitation using high-sensitivity triple quadrupole; identify, characterize, and quantitate metabolites more quickly and easily; identify and sequence post-translationally modified (PTM) peptides automatically in a single LC/MS/MS run; facilitate hypothesis-driven biomarker discovery and validation.
Press Releases/Archive
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