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.

Medelpharm of France (Booth 2439) will present its STYL'One 105ML mechanical multilayer press at AAPS. STYL'One, which is the fastest and most versatile machine on the market for the single-punch R&D production of tablets, according to the company, is primarily designed for use in pharmaceutical research laboratories, but is also suitable for use in the production of food, detergents and cosmetics.

The STYL'One press incorporates the latest technological developments, including a unique patented mechanical design which guarantees precision and robustness under load. The main drive is programmable, offering a range of functionality and versatility that was not previously available. ANALIS, the data-acquisition and control software package supporting the machine, is an open platform featuring the latest technology in data acquisition.

STYL'One has a compression time that is five times faster than similar presses routinely used in R&D facilities, with a minimum time of below 40ms to reach compression peak. This machine can produce and study multilayer tablets at high speed (up to five layers with three powders). The technology for compression is unique and extremely versatile, enabling the user to generate displacement-driven studies (95% of R&D and production tablet presses); force-driven studies (used mainly in R&D and powder characterisation); and a combination of both modes on the same tablet.

The STYL'One 105ML model with multilayer capabilities, which is designed primarily for the pharmaceutical market, will be available from the second quarter of 2010. Additional functionalities are already under development on the STYL'One platform, including dry coating and larger-than-standard tooling. Medelpharm's strategy has always been to protect its customers' investments by making its technological improvement backward-compatible. The pricing of the STYL'One makes it affordable for the majority of organisations that require multilayer capabilities. Medelpharm aims to make this new machine an industry standard by making some of the unique functionalities already provided by its STYLCAM 200R rotary press simulator more widely available.

The STYL'One tablet press is robust, clean, easy to use and offers fast and simple clean-up. It is made of GMP-approved material and is compliant with most regulatory standards. The machine is compact, measuring 70cmx70cmx180cm and weighing 1100kg, enabling it to be moved easily around a building.

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.

Pharmatek Laboratories (Booth #919) has re-launched its Hot Rod Chemistry® Formulation Screening Kit. The new formulation screening kit is Pharmatek’s latest addition to their products and services designed to improve solubility, bioavailability and stability of drug candidate compounds.

“The goal of the Hot Rod Chemistry Kit is to simplify and streamline the process of screening potential drug candidates while improving the solubilization capacity and safety profile of the vehicles. The new set of eight non-toxic, orally available formulations in the kit has been optimized to suit a more diverse and challenging pool of initial screening compounds,” said Jeffery A. Bibbs, Ph.D., chief executive officer and chief scientific officer at Pharmatek.

Each of the eight formulations are designed to solubilize the most difficult drug candidates with excipients that are GRAS and can be found in FDA-approved therapeutics. Quick and easy solubility through the use of HRC can eliminate the need to reformulate any candidates, which speeds up the drug development process. Once solubility is achieved using the kit, the formulated compounds can directly be dosed to animals, according to the company.

Not only can new compounds be screened, but compounds that had once been deemed to have poor solubility or bioavailability can be revisited, and enable quick and safe advancement towards the clinic. HRC has become an inexpensive vehicle to alleviate any obstacles with solubility in the drug discovery process, simultaneously lowering costs and increasing the number of viable drug candidates in the development pipeline.

Qualicaps, Inc. (Booth 1101) has introduced the S-1, a lab‐scale capsule band‐sealer. Simulating the sealing process of a commercial scale S‐40 or S‐100 capsule band‐sealing machine, the S‐ 1 Lab‐Top Capsule Sealer is capable of sealing between 100 and 1000 capsules per hour depending on change parts.

The S‐1 is easy to use, assures the company, and supports a variety of capsules sizes including 00, 0, 1, 2, 3 and 4. To use the S‐ 1, filled capsules are manually loaded into capsule carrying slats. The slats pass through a band‐sealing process that is identical to commercial‐scale machines and are transferred to the drying rack.

Other Benefits of the S‐1:

Highly accurate seal
Easy changeover and cleaning
Low volume runs for clinical trials, comparative or stability studies
A method to test capsule and seal color combinations
Can seal gelatin or Quali‐V® (hypromellose) two‐piece capsules
Same integrity and reliability as any S‐40 or S‐100 commercial‐scale machine

Shimadzu Scientific Instruments (Booth 1310) features the BioSpec-nano, a dedicated spectrophotometer for the quantitation of nucleic acids. Life Science researchers can conserve precious samples and obtain accurate and reproducible results made possible by an automated precision drive mechanism.

The BioSpec-nano only requires 1 μL (path length: 0.2mm) or 2 μL (path length: 0.7mm) of sample, which is pipette onto the measurement plate. For ultra-small sample volumes no standard rectangular cell is needed although for applications that are not volume-limited, an optional rectangular cell adapter is available. With the most automatic functionality available on the market, sample mounting, measurement and cleaning are conducted by the instrument. The operators need not perform tedious, repetitive, and inconsistent placement of the fiber optic element and manual cleaning required in other instruments. Sample measurement time is three seconds.

Dedicated software allows simple and quick operation of the BioSpec-nano. The start, exchange wiper, list, detail, save CSV/PDF and display PDF operations are displayed on the toolbar according to the user’s procedure and available with the click of a button.

The BioSpec-nano is an ideal instrument for research in genomics, molecular biology, agriculture, medical science, and food quality.

Visit Shimadzu Scientific Instruments at Booth 1310!

The McCrone Group (Booth 2350) presents its Freeze Dry Microscopy System for parenteral drugs. Freeze drying, as a unit operation in the production of parenteral drugs, is becoming more prevalent as new molecular entities coming out of discovery have less than two years of shelf life before they expire. Therefore, pharmaceutical formulators are using freeze drying (also known as lyophilizing) to extend the shelf life of their drugs. Requiring expensive, large-scale machines, freeze drying can be the most expensive and time-consuming step in the parenteral manufacturing process — until now.

To minimize cost and wasted efforts, many companies developing new products find it in their best interest to optimize their lyophilization cycles by looking at other methods that get the job done, like freeze dry microscopy. McCrone recently came out with a small, low cost freeze dry microscopy system, “The McCrone Freeze Dry Microcopy System.” Visiting Booth 2350 to hear about the system, and get an inside industry perspective on trends in parenteral lyophilization and development.

Thermo Fisher Scientific Inc. (Booth 2001) introduced the new Thermo Scientific Evolution 60S spectrophotometer, a powerful UV-Visible instrument designed with the flexibility to perform QA/QC, life science and general research methods at AAPS. The Evolution™ 60S features a 1.0 nm spectral bandwidth, bringing a new level of clarity to measurements in an affordable, compact design, the company contends. Enhanced scanning technology acquires high-quality spectral data at speeds greater than 4,200 nm per minute. Evolution 60S spectrophotometers meet the stringent requirements of international pharmacopeias and offer validation tools and protocols for customers in the regulated marketplace.

The long-life xenon lamp of the Evolution 60S requires no warm-up time, providing instant measurements and excellent performance over the entire wavelength range of 190-1100 nm. Guaranteed for three years of continuous use, the lamp typically provides five to seven years of maintenance-free operation, dramatically increasing instrument availability and decreasing requalification requirements that result from frequent lamp changes. Furthermore, the lamp is only on when taking measurements, ensuring temperature stability in the Evolution 60S sample compartment and protecting sensitive samples from exposure to intense UV light.

Life science applications are supported with a wide array of pre-programmed biological assays for analyzing protein and nucleic acid samples and performing cell growth measurements. The Evolution 60S comes standard with a six-position cell changer and aluminum base plate single cell holder for enhanced functionality with advanced sampling accessories. Furthermore, additional PC software is available to assist customers in performing the most common methods for enzymatic food and beverage, color and materials transmission analyses.

System qualification packages are available to support qualification and validation activities. Performance verification tests included in the embedded software of every Evolution 60S ensure optimal instrument performance in accordance with GLP and GMP procedures.

Varian, Inc. (Booths 2200, 2201) has released its 325-MS triple-quadrupole LC/MS (liquid chromatograph/mass spectrometer) for the efficient detection and identification of chemical compounds in high-throughput laboratories performing environmental, food safety, and toxicology analyses.

Analytical chemists face the challenge of identifying a growing list of compounds from an increasing number of samples in a variety of matrices. To remain competitive, laboratories must maximize the number of compounds they can detect and quantify in a single analytical run while minimizing the time spent on maintaining the instrument. The 325-MS, Varian's next-generation LC/MS triple-quadrupole mass spectrometer, features a novel ESI ion source and improved ion-optics that jointly enhance sensitivity, ruggedness and throughput.

At the heart of the 325-MS is Varian's patent pending vESI™ ion source, a vortex ESI ion source that improves sensitivity by increasing the efficiency of the desolvation process. A vortex of drying-gas facilitates ion desolvation at lower temperatures, accommodating a wider range of flow-rates for small molecule analysis as well as biomolecules without compromising system performance. Chemists can take advantage of the improved sensitivity by either lower detection limits for some compounds or by analyzing more compounds in a single run, increasing throughput and reducing the cost per analysis.

Gold-Guard™ ion optics (patent pending) provide enhanced contamination resistance. The 325-MS requires little to no cleaning in order to maintain a high-level of reproducibility and accuracy even after repeated injections of analytes suspended in a complex matrix. Fewer cleanings mean greater uptime and more productivity, again reducing the cost per analysis.

In order to help customers get the most from their instrument, Varian also provides consumables, including sample preparation tools and HPLC columns, as well as applications assistance and a comprehensive selection of support and training options.

"Maintaining and even increasing throughput is essential for laboratories performing environmental analyses and food safety testing," said Martin O'Donoghue, Senior Vice President, Scientific Instruments, Varian, Inc. "The 325-MS allows users to gather more information from each run while spending less time maintaining the instrument."