industry pr

Press release news from the public relations clients of Tiziani Whitmyre, Inc.

Posts Tagged ‘biotechnology’


Wednesday, March 11th, 2015

Whitepaper Details 15 Best Practices for Institutional Biosafety Committees to Improve Functionality, Compliance

Elizabeth Gilman Duane, M.S., RBP, CBSP; Practice Director, Life Sciences; Environmental Health & Engineering, Inc.

Elizabeth Gilman Duane, M.S., RBP, CBSP; Practice Director, Life Sciences; Environmental Health & Engineering, Inc.

Needham, Mass. — March 11, 2015 — Fifteen best practices to help Institutional Biosafety Committees (IBCs) improve their functionality and compliance — and better protect their workers, communities, and institutions — are detailed in a new whitepaper available to download at http://www.eheinc.com/ibc_practices.htm.

The whitepaper is titled “Best Practices for a Highly Functioning, Compliant Institutional Biosafety Committee.

“Last year there were several lapses in safety practices at Federal laboratories, drawing significant attention and compromising the public’s confidence in biomedical research,” said whitepaper author Betsy Gilman Duane, MS, RBP, CBSP, Practice Director, Life Sciences at Environmental Health & Engineering (EH&E).

“But each Institutional Biosafety Committee is unique. After satisfying the requirements of the National Institutes of Health (NIH) and their local communities, the best practices recommended in the whitepaper can enhance the experience for IBC members, facilitate compliance as well as science, and provide opportunities for improvement for Institutional Biosafety Committees as the cornerstone of their institution’s Biosafety Management System,” she stated.

The 15 best practices addressed in the whitepaper involve the scope of the Institutional Biosafety Committee, data collection, training, leadership, conflicts of interest, project and procedure reviews and audits, biosafety officer qualifications, public communications, disposition of materials, and others.

Gilman Duane is past president of the American Biological Safety Association (ABSA), facilitated the establishment of the New England Biosafety Association (NEBSA), and is on the Board of the Eagleson Institute. At EH&E, she oversees biological safety and environmental health and safety programs for life science clients.

To download the whitepaper, Best Practices for a Highly Functioning, Compliant Institutional Biosafety Committee,” visit http://www.eheinc.com/ibc_practices.htm.

 ###

About EH&E

EH&E a leading provider of environmental and engineering consulting services, guarantees that its application of science and engineering best practices will deliver measurable, quantifiable benefits in all aspects of the built environment. EH&E’s focus on evidence-based decision making and advanced capabilities in analytics and technology innovation help its clients achieve and quantify optimal performance from their people and assets. For more information, visit the EH&E website at www.eheinc.com.


Tuesday, July 13th, 2010

New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products

microtest-logo1

AGAWAM, MASS. – July 13, 2010 – A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/).wpcover1

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, “Combination Products 2.0: Applying the New FDA Regulations,” Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20/). In the white paper, Dr. Richter discusses:

  • The New Regulations
  • Determining Principal Mode of Action — Device or Drug?
  • Stem Cells & Human Tissue in Combination Products
  • The Implications for Testing and Validation
  • An Example: Drug-Eluting Stents

“The new FDA regulations governing combination products are a major step forward for the industry. They apply to parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements,” Dr. Richter said.

Download a free copy of “Combination Products 2.0: Applying the New FDA Regulations” from http://www.microtestlabs.com/combination-products-20/.

Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

# # #

Public Relations contact, Boston:  Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations


Monday, April 20th, 2009

Advanced Instruments Introduces 2020-BIO Multi-Sample Osmometer as First True Automation-Friendly Osmometer for the Biopharmaceutical Industry

NORWOOD, MASS. – April 20, 2009 – Advanced Instruments, Inc. today introduced the Advanced® 2020-BIO Multi-Sample Osmometer as the first true automation- friendly osmometer for the biopharmaceutical industry.

“The Advanced® 2020-BIO Multi-Sample Osmometer is specifically designed for – and completely redefines – automation capabilities for osmolality testing in the biopharmaceutical laboratory,” said Kelly Peterson, Product Manager, Advanced Instruments (http://www.aicompanies.com/). “The 2020-BIO system development is in response to emerging demand in the pharmaceutical industry to integrate osmolality testing within an automated platform environment.”

“Based on an extension of the industry-proven Advanced 2020 Osmometer, the 2020-BIO includes a host of features which enable fast and simple integration of the system with liquid handling robotics and laboratory automation platforms.” Peterson said.

The 2020-BIO has been successfully applied to automate osmolality testing in applications ranging from cell culture process development and optimization to biopharmaceutical manufacturing and process control. It can also be extended to pharmaceutical research and drug development applications including formulation development, product stability testing, and drug safety and metabolism testing.

Major features of the new 2020-BIO include:

  • Freezing point technology – The industry-preferred method for determining sample concentration
  • Automation friendly system design allows easy access for liquid handling robotics
  • Interoperability with a broad range of robotics and liquid handling equipment
  • Flexible system configuration options provide continuous sampling capabilities for enhanced throughput
  • Bidirectional data transfer utilizing the preferred OPC open connectivity protocol
  • Remote system control via an industry-standard RS-232 interface for secure connectivity to a PC.
  • Fast and simple integration – the developer’s kit includes a .DLL for osmometer controls, making automation development easy to achieve.
  • Small 20 µL sample sizes – ideal for sample-limited applications or for sharing sample volume with other integrated systems.

The bottom line is that the 2020-BIO is the only commercially available system that provides fast, accurate osmolality testing in an automation friendly package,” Peterson said.

The Advanced® 2020-BIO Multi-Sample Osmometer from Advanced Instruments is available immediately for shipment in the United States and Canada. For more information, visit the Advanced Instruments website at www.aicompanies.com/2020-BIO, or call 1-800-225-4034 or 1-781-320-9000.

About Advanced Instruments, Inc.
Founded in 1955, Advanced Instruments, Inc. (http://www.aicompanies.com/) is the world’s largest supplier of freezing-point cryoscopes and osmometers used in dairy, clinical, pharmaceutical, and biotechnology laboratories. The company is also a leading supplier of analytical instruments for the food and industrial microbiology markets. Based in Norwood, Massachusetts, USA, the privately held company also produces Fiske® Associates brand diagnostic instruments and operates Spiral Biotech, Inc., D&F Control Systems, Inc., Mart Microbiology, and Delta Instruments as wholly-owned subsidiaries. A worldwide network of direct sales people and independent distributors supports Advanced Instruments’ products.

# # #

Public Relations contact: Tiziani Whitmyre Inc. , http://www.tizinc.com/


Thursday, July 10th, 2008

Advanced Instruments to Showcase Model 3320 Osmometer at 2008 AACC Annual Meeting and Clinical Lab Expo

– One-step osmometry delivers accurate, reliable results in one minute –

Washington D.C. – July 10, 2008 – Advanced Instruments, Inc. (www.aicompanies.com), of Norwood, Massachusetts, will showcase the Model 3320 Single-Sample Micro-Osmometer at the 2008 AACC Annual Meeting and Clinical Lab Expo, July 27-31, 2008, in Washington, DC.

The Model 3320 is an automated, single-sample freezing point depression (FPD) micro-osmometer that determines the total concentration of dissolved molecules in biological fluids, such as serum or urine. The technology is utilized by clinical laboratories and clinicians to provide fast, accurate and precise results for monitoring and diagnosing fluid and electrolyte imbalances.

“Our FPD osmometers have been used in clinical chemistry laboratories for more than 40 years, as they provide a direct measurement of osmolality,” said Peter Costas, Vice President of Sales and Marketing for Advanced Instruments (www.aicompanies.com).

A low profile and compact instrument, the Model 3320 offers simple architecture that eliminates sample errors, simplifies testing, and promotes maintenance-free operation.

Additional features of the Model 3320 include:

  • Requires only a 20µL sample
  • Superior accuracy and precision
  • On-board statistical analysis
  • Results recall up to the last 30 tests
  • Utilizes the industry-preferred freezing point method

For more information on Advanced Instruments, visit booth #230 at the 2008 AACC Annual Meeting and Clinical Lab Expo. Visit the company on the Web at www.aicompanies.com,or call (800) 225-5034.

About Advanced Instruments
Founded in 1955, Advanced Instruments, Inc. is the world’s largest supplier of freezing-point osmometers used in clinical, pharmaceutical, and biotechnology laboratories. The company is also a leading supplier of analytical instruments and test kits for the food, dairy, and industrial microbiology markets. Based in Norwood, Massachusetts, USA, the company also produces Fiske® Associates brand diagnostic instruments and operates Spiral Biotech, Inc., and Delta Instruments as wholly owned subsidiaries.

Advanced Instruments’ products are supported by a worldwide network of sales professionals and independent distributors. Reach Advanced Instruments online at www.aicompanies.com or contact customer service at (800) 225-4034 or +1 (781) 320-9000.

# # #

Public Relations contact: Tiziani Whitmyre Inc. , http://www.tizinc.com/


Monday, March 10th, 2008

Advanced Instruments to Highlight Protein-Based Control for Osmometers

- Accuracy, consistent performance to be presented at CLMA ThinkLab -

ATLANTA, GEORGIA – March 10, 2008 – Advanced Instruments, Inc. (http://www.aicompanies.com/) will highlight their Protinol® Protein-Based Controls at the CLMA (Clinical Laboratory Management Association) ThinkLab ‘08 Conference & Exhibition.At the show, Advanced Instruments will speak to the product’s consistency and accuracy in the human serum range. Protinol is specifically formulated at three levels, enabling compliance with Clinical Laboratory Improvement Amendments (CLIA) quality control requirements.

“In order to comply with CLIA requirements, the clinical laboratory scientists should perform and document control procedures using at least two levels of control materials daily,” said Eileen Garry, Director of Regulatory Affairs and Scientific Liaison at Advanced Instruments. “Protinol is an ideal product for any clinical laboratory that demands consistent, reliable results.”

Designed for use in clinical laboratories that test blood samples, the Protinol Protein-Based Controls come premixed and ready to use.

When used with Advanced Instruments’ osmometers, product features include the ability to:

  • Track control results
  • Identify shifts, trends, and random errors
  • Apply control rules
  • Implement corrective actions

For more information on Protinol and other osmometer accessories, visit Advanced Instruments in booth #118 at CLMA ThinkLab ‘08. Or contact the company on the web at http://www.aicompanies.com/ or by phone (800) 225-5034.

About Advanced Instruments
Founded in 1955, Advanced Instruments, Inc. is the world’s largest supplier of freezing-point osmometers used in clinical, pharmaceutical, and biotechnology laboratories. The company is also a leading supplier of analytical instruments and test kits for the food, dairy, and industrial microbiology markets. Based in Norwood, Massachusetts, USA, the company also produces Fiske® Associates brand diagnostic instruments and operates Spiral Biotech, Inc., and Delta Instruments as wholly owned subsidiaries.

Advanced Instruments’ products are supported by a worldwide network of sales professionals and independent distributors. Reach Advanced Instruments online at www.aicompanies.com or contact customer service at (800) 225-4034 or +1 (781) 320-9000.

# # #

Public Relations contact: Tiziani Whitmyre Inc. , http://www.tizinc.com/


Tuesday, October 2nd, 2007

Advanced Instruments Introduces World’s Fastest High Throughput Freezing Point Osmometer

NORWOOD, MASSACHUSETTS – October 2, 2007 – Advanced Instruments, Inc. (http://www.aicompanies.com/) today introduced the world’s fastest freezing point osmometer to the biotechnology industry. The revolutionary high throughput Multi-Sample 20G Osmometer measures 96 samples in about 35 minutes.

Designed to automate laboratory work and reduce the time for cell culture process optimization, the high throughput Multi-Sample 20G Osmometer (www.aicompanies.com/20G) incorporates eight computer controlled osmometers and a robotic sample handling system, all enclosed in a safety cabinet.

“Scientists and laboratory directors face a growing need for better tools to perform cell culture process development. The new Multi-Sample 20G Osmometer meets the process parameters demanded to accurately measure at high volumes, as is customary with drug discovery,” said Peter Costas, Vice President of Sales and Marketing at Advanced Instruments.

With the new Multi-Sample 20G Osmometer, biotechnology researchers are equipped with:

  • Eight computer-controlled analysis units
  • Accurate osmolality measurement in clinical, industrial, and research settings
  • Robotic system that quickly provides smooth, automated sample handling
  • Enclosed components in an easily accessible safety cabinet
  • Random-access, fully programmable system controls
  • Statistical analysis components that provide mean, standard, deviation and coefficient of variation functions
  • Data export
  • LIMS user interface
  • Flexible reporting options and results storage/retrieval
  • Barcode reader that provides additional input options
  • Sterile consumables containment area that prevents contamination of cell culture reactors

“The Multi-Sample 20G Osmometer combines the freezing point depression method of osmolality measurement with a 96 well format, providing the unmatched combination of speed, accuracy and versatility required by biotechnology scientists and laboratory directors,” said Costas.

The Multi-Sample 20G Osmometer operating process begins when 96 sample tubes are presented to the system at the start of a cycle in a modified, microplate (SBS) format. The automated sample handling system then moves the tubes and probe cleaners to and from the eight osmometers. Results are displayed on a color touch-screen monitor and can be automatically transferred to a central database.

For more information on the Multi-Sample Model 20G Osmometer visit www.aicompanies.com/20G, or contact Advanced Instruments directly by email at: info@aicompanies.com or by phone: 1-800-225-4034.

About Advanced Instruments
Founded in 1955, Advanced Instruments, Inc. is the world’s largest supplier of freezing-point osmometers used in clinical, pharmaceutical, and biotechnology laboratories. The company is also a leading supplier of analytical instruments and test kits for the food, dairy, and industrial microbiology markets. Based in Norwood, Massachusetts, USA, the company also produces Fiske® Associates brand diagnostic instruments and operates Spiral Biotech, Inc., and Delta Instruments as wholly-owned subsidiaries.

Advanced Instruments’ products are supported by a worldwide network of direct sales people and independent distributors. Reach Advanced Instruments online at http://www.aicompanies.com/ or contact customer service at (800) 225-4034 or +1 (781) 320-9000.

# # #

Public Relations contact: Tiziani Whitmyre Inc. , http://www.tizinc.com


Monday, September 10th, 2007

New White Paper Details Strategies for Biotechnology Companies to Improve EH&S Compliance

NEWTON, MASS. – September 10, 2007 – A free white paper detailing strategies to help biotechnology companies improve compliance with federal, state, and local environmental health and safety regulations is available for download at: http://www.eheinc.com/pitfalls.htm.

The white paper, titled “Environmental Health and Safety Compliance in Biotech Companies: Common Deficiencies Encountered During Audits,” is based on an analysis of numerous program audits, and offers small and mid-size biotechnology companies an opportunity to avoid costly oversights.

“All biotechnology firms are required to meet complex regulatory compliance requirements from a variety of governing sources,” said Jack McCarthy, President and co-founder of EH&E (http://www.eheinc.com/), a Newton, Mass. based environmental engineering and consulting firm. “Larger firms employ full-time professional staff to manage their responsibilities. Small and mid-size firms often cannot afford the expense or dedicate the manpower to fully meet these requirements, and are therefore more at risk of violations and sanctions.”

Compliance areas covered by the white paper include:

  • Environmental Compliance (air emissions, wastewater, and waste management)
  • Permitting and Plans
  • Employee Training
  • Biosafety
  • Occupational Health and Safety
  • General Documentation Deficiencies

Within each compliance area, the white paper details examples of the most common violations encountered during routine audits and summarizes a list of recommendations for maintaining a continual high level of compliance using limited manpower. Download the free white paper at: http://www.eheinc.com/pitfalls.htm.

For more information on EH&E visit http://www.eheinc.com/ or call 1-800-825-5343.

About EH&E
EH&E (http://www.eheinc.com/) has provided an extensive range of environmental and engineering consulting services for over 18 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients. Our new series of EH&E web compliance solutions is just the latest example of our continuing effort to provide this knowledge and information to a wider range of companies.

# # #

Public Relations contact: Tiziani Whitmyre Inc., www.tizinc.com


Tuesday, January 30th, 2007

EH&E Offers New, Free White Paper to Help Biotech Companies Improve Environmental Health and Safety Compliance

NEWTON, MASS. – January 30, 2007 – EH&E has announced the availability of a new, free white paper, “Environmental Health and Safety Compliance in Biotech Companies: Common Deficiencies Encountered During Audits,” for download at: http://www.eheinc.com/pitfalls.htm.

Biotech companies must comply with complex regulatory requirements mandated by federal, state, and local agencies. Larger firms employ full-time professional staff to manage these responsibilities. Small and mid-size firms often cannot afford the expense or dedicate the manpower to fully meet these requirements, and are at an increased risk of violations and sanctions.

The white paper provides detailed examples of the most common violations encountered during routine audits of biotech companies and summarizes a list of recommendations for maintaining a continual high level of compliance using limited manpower.

Based on an analysis of numerous EH&S program audits, the white paper offers small and mid-size biotech companies an opportunity to avoid costly oversights. Compliance areas covered by the white paper include:

  • Environmental Compliance (air emissions, wastewater, and waste
    management)
  • Permitting and Plans
  • Employee Training
  • Biosafety
  • Occupational Health and Safety
  • General Documentation Deficiencies

For more information, contact EH&E at: http://www.eheinc.com or by phone at: 1-800-825-5343.

Download the free white paper at: http://www.eheinc.com/pitfalls.htm.

About EH&E
EH&E (http://www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for over 18 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients.

Our new series of EH&E web compliance solutions is just the latest example of our continuing effort to provide this information to a wider range of companies. eH&E-Biotech provides much of EH&E’s compliance expertise to smaller organizations through a web-based portal, and in a very affordable way. The solution provides a complete outline of a comprehensive EH&S compliance management program, and includes tools, databases and document templates to facilitate easy program development and maintenance.

# # #


B2B News is proudly powered by WordPress.
WordPress