New Products

Bioanalytical Systems, Inc. (BASi, Booth 2301) provides clients with increased sample analysis speed and quick turnaround with Laser Diode Thermal Desorption (LDTD) technology. Fast screening is combined with accurate quantification results, to benefit any bioanalytical studies, according to a company statement.

LDTD technology is an innovative technique that introduces all samples into the mass spectrometer by a rapid laser thermal desorption process, where they are ionized by an atmospheric pressure chemical reaction (LDTD-APCI) and fully analyzed 10 to 20 times faster than with current LC-MS/MS systems, without compromising accuracy. LDTD is an ion source for mass spectrometry, working without any LC apparatus.

“BASi’s use of LDTD technology can reduce sample analysis time to a fraction previously required by LC-MS/MS,” stated Tony Chilton, BASi's chief operating officer, Scientific Services. “With this new technology we will be able to provide our clients with another outstanding tool for sample analysis.”

Recently, BASi presented a poster on LDTD technology at the ASMS Conference on Mass Spectrometry, “Validation of Pioglitazone in Human Serum by Two Sample Introduction Methods: LDTD-APCI/MS/MS and LC-ESI/MS/MS.” The poster is available at http://www.basinc.com/library/presentations.html.

BASi (Booth 2301) is announcing two new products for automated blood collection (ABC) at AAPS: Culex® ABC and Culex®-L ABC, which provide solutions to automated blood sampling. BASi is the industry leader in specialized instrumentation and accessories for in vivo sampling products.

The BASi family of Culex products has always provided researchers the best automated means to collect in vivo samples, according to a company statement. The new Culex ABC units are simplified versions of the original movement-responsive Culex system, giving the option to collect only blood if an integrative pharmacology approach is not needed. The Culex ABC is designed for rodents and other small animals, while the Culex-L ABC is for large animal models, including swine and primates. Features of the new BASi Culex ABC and Culex-L ABC include:

Automated, stress-free, hands-off sampling
Adaptable to a home cage for animal security and comfort
Freedom from time-consuming manual sampling
Day or night sample collection without an operator present
Permits using most swivels, catheters, and tethering systems
Multiple systems controlled from a single computer with individual user-defined volumes and methods

“The new Culex ABC units provide a simple, straightforward solution to automated blood collection in small and large animal models,” stated BASi Instruments Division Senior Vice President, Craig Bruntlett, Ph.D. “The ability to collect samples any time day or night without an operator provides researchers with the best automated means to collect in vivo samples.”

See BASi at Booth 2301!

BioConvergence (Booth 1062) is a biopharma contractor providing development, production, testing, supply chain and consulting services to more than 100 life sciences companies. The company has integrated its service offerings to provide clients more seamless product development options to meet preclinical and clinical materials needs. Recent developments include:

• Optimizing product lyophilization cycle to reduce time and cost of product manufacturing - In response to a client's lyophilized product that turns into a powder at the bottom of the vial during processing and a cycle that lasts for three-plus, days, BioC screened several lyo / cryprotectants as excipients / bulking agents, performed thermal analysis on optimized formulation, and optimized lyo cycle, resuting in a pharmaceutically elegant cake and a lyo cycle reduced by 66%.

• QC testing for product release to help a client deal with unexplainable variations in product release and stability data. By evaluating historical data and data trends, BioC evaluated product release methods and recommended sample preparation and method improvements, getting marked improvements in the precision of the client's product release and stability results.

BioConvergence LLC is a small, women-owned privately held company located in Bloomington, IN.

Brookhaven Instruments Corp. (Booth 1462) is debuting BioDLS, a new Microplate Particle Sizer, at AAPS. The instrument combines the power of Dynamic Light Scattering with modern automatic liquid handling to yield unsurpassed convenience and accuracy in formulation characterization and aggregation assays, the company contends.

BioDLS allows automatic particle sizing using industry-standard well plates. The precision controlled sample transfer mechanism allows the user to select any arbitrary well to initiate the experiment, transferring as little as a 2µL sample volume required for measurement, and allows recovery of the transferred sample.

Users of BioDLS can obtain such benefits as

automating experiments and obtaining results rapidly
conserving precious samples
performing experiments with no consumable costs
detecting aggregation at its onset
analyzing samples without dilution
minimizing toxic chemical exposure with robotics
interpreting data using established theory

Lampire Biological Laboratories (Booth 1360) has added Zebrafish Teratology Screening to its slate of offerings. The zebrafish has proven to be a useful animal model for studying teratology, toxicology, drug discovery, ecological and environmental sciences, and many other areas of biomedical research, according to a Lampire statement. The company uses zebrafish embryos for its screening, describing the process as follows:

The zebrafish spawns early in the morning, allowing eggs to be harvested that same morning,
embryos are cultures in a dose range of the compound of interest, plus a vehicle control,
at five days post-fertilization, embryos are scored for developmental defects, assessing nine major morphological endpoints, and
compounds are assigned a probability of teratorgenicity based on lethality of the compound and occurrences of developmental defects.

Lancaster Laboratories (Booth 1817) has announced a new method for detecting melamine in pharmaceutical products that uses LC/MS/MS to provide greater sensitivity and specificity over other techniques. Lancaster Laboratories’ new method meets the FDA's August 2009 guidance, entitled Pharmaceutical Components at Risk for Melamine Contamination, which identifies raw materials that are considered high-risk for melamine contamination and recommends monitoring of these raw materials for the presence of melamine prior to release into production.

Melamine is used in the manufacture of a variety of products, including resin based products (countertops, glues, house-wares, etc), cleaning products and industrial cleaners. Melamine has a low acute toxicity and is not readily metabolized. Cyanuric acid, which also has a low acute toxicity, is a structural analogue of melamine and is used in the manufacture of herbicides, dyes, resins and antimicrobial agents. It is also used as a stabilizer and disinfectant in swimming pools and as a component of feed grade biuret (a ruminant feed additive).

The combined presence of melamine and cyanuric acid leads to the formation of melamine cyanurate. This compound has low solubility which can lead to the formation of crystals in the kidneys, a condition known to cause renal failure, kidney toxicity and, in some subjects, death.

Two recent incidents led the FDA to assess the potential impact of melamine in pharmaceutical products. First, in 2007, numerous deaths and illnesses in both cats and dogs led investigators to discover melamine in both wheat gluten and rice protein used as a pet food thickener. This led to a mass recall of pet food products. In 2008, melamine-contaminated infant formula in China was linked to illness in more than 50,000 infants and to the deaths of at least six infants.

PharmaForm (Booth 547), a contract pharmaceutical development and manufacturing organization and a wholly owned subsidiary of Akela Pharma Inc., has added aqueous and solvent spray drying to its portfolio of bioavailability enhancement solutions. Spray drying offers a number of benefits to optimize drug formulation, including enhanced bioavailability of poorly soluble compounds, higher drug loading and predictable scale-up.

"PharmaForm's investment in the Anhydro MicraSpray 3S® is part of the company's strategic focus and commitment to provide comprehensive solutions for poorly soluble compounds," said Gregory M. McKee, president and chief executive officer of Akela Pharma. "Spray drying further enables us to better serve our clients by offering another proven, commercializable technology to enhance bioavailability and accelerate their drug development programs."

In addition to the new spray drying capability, PharmaForm's comprehensive bioavailability enhancement technologies include hot-melt extrusion, solvent-based fluid bed processing and liquid filled hard capsules.