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Posts Tagged ‘pharmaceuticals’


Monday, July 20th, 2015

Free Literature News: SPECTROSCOUT Portable ED-XRF Analyzers

SCOUT Family pg1FREE brochure details new SPECTROSCOUT portable ED-XRF analyzers that bring lab-quality elemental analysis for field or offsite testing for environmental screening, petrochemical exploration as well as laboratory and at-line quality control (QC) testing for processed and manufactured goods (chemicals, oil, metal surface coatings, pharmaceuticals, cosmetics, food, feedstock, etc.).

SPECTRO ANALYTICAL INSTRUMENTS
1.800.548.5809
http://xrf.spectro.com/wp-content/uploads/brochure_spectroscout_family.pdf

 


Monday, May 12th, 2014

Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of White Paper

AGAWAM, MASS. – May 12, 2014 – A white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is available from Microtest Laboratories. It is available for download from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from http://microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories

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.


Tuesday, October 22nd, 2013

Use of Stability Studies in Drug, Combination Products & Medical Device Development are Reviewed in New Whitepaper

AGAWAM, MASS. — October 22, 2013 —The use of stability testing in new product development — of drug substances, drug products, combination products and some medical devices — is reviewed in a new whitepaper from Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

The paper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development” (download from: http://microtestlabs.com/stability-studies), outlines how stability studies can be used to gather valuable information about a new product and prevent unnecessary manufacturing costs and time delays.

Stability studies can help determine formulation and manufacturing strategy, analytical assay development and validation — and help explain unexpected and failing results. They can also provide input to manufacturing controls, and help identify final packaging requirements. The paper examines three specialized stability studies as examples:

  • Forced degradation studies, which involve exposing the product to predetermined stress conditions in order to intentionally form likely degradation products;
  • Photostability testing, used to determine the product’s ability to withstand exposure to light without any adverse effects;
  • Temperature cycling studies, used to assess the impact of temperature changes on the product.

Two case studies, one involving a drug product and one a combination product, are also presented.

The use of stability studies in the development of new drug or combination products can ease both the planning and execution of a development strategy. Moreover, the studies may also help prevent unnecessary costs and time delays due to poor formulations, assay failures, and manufacturing problems.

Download the new whitepaper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development,” from: http://microtestlabs.com/stability-studies.

About Microtest Laboratories

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


Wednesday, October 2nd, 2013

“Combination Products: What You Need to Know” Seminar for Medical Device, Pharmaceutical Manufacturers is Scheduled for October 31st in Boston

AGAWAM, MASS. — October 2, 2013 — A full-day technical seminar designed to assist medical device and pharmaceuticals with what they need to know about manufacturing combinations products, including best practices and applicable FDA regulations, is scheduled for Thursday, October 31st, in Waltham, Mass., just outside Boston.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent more than 30% of all new FDA product submissions. But for manufacturers, the convergence of drugs, biologics, and devices presents a host of best practice and regulatory issues.

Titled “Combination Products: What You Need to Know,” the seminar will outline a realistic approach for manufacturers to navigate the testing, production, and regulatory standards related to the manufacture of combination products. Topics will include:

  • Combination Products —What You Need To Know: Overview of regulatory hurdles for combination products highlighting the determination of PMOA.
  • Applications of Lean to Combination Product Manufacturing: Case studies specific to applying lean to manufacturing of combo products for clinical use.
  • In-Process and Release Testing PTC: Outline of in-process and release testing points to consider during development and specification determination.
  • EM Monitoring of GMP Manufacturing Space: Current EM procedures for setting up GMP manufacturing.
  • Choosing the Right CMO: Discussion of best practices to determine a right fit CMO.

Combination Products: What You Need to Know,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration is at 9:00 a.m. Continental breakfast, break refreshments and luncheon is included.

To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The seminar is one in a continuing series of technical events presented by Microtest Laboratories for medical device and pharmaceutical manufacturers. The seminars tend to fill up quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that 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.


Monday, March 12th, 2012

New White Paper: How a Flexible Bioprocessing Platform Meets the Changing Needs of Biomanufacturing

 

 

 

MARLBOROUGH, MASSACHUSETTS, USA — March 12, 2012 — A new white paper detailing how a flexible bioprocessing platform meets the changing needs of biomanufacturing is now available for download from Xcellerex, Inc., at http://www.xcellerex.com/flexpaper. 

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These include the rise of small-market pharmaceuticals, increased titers and process productivity, the emergence of biosimilars, the evolution of healthcare reform, greater competition and tighter capital markets.

As manufacturing and facilities managers confront these challenges — and are still tasked with meeting today’s capacity needs — many are turning to a new flexible factory platform that will accelerate their implementation of biomanufacturing capacity while lowering risk, reducing time to market and reducing capital costs.

A new white paper, “The Flexible Factory Concept: A Flexible Bioprocessing Platform to Meet the Changing Needs of Biomanufacturing,” examines the approach which enables the deployment of new production capabilities in 9 to 18 months (versus 3 to 5 years for today’s technology) at a total cost of less than 50% to 80% of conventional plants.

The white paper defines the “Flexible Factory Concept” as  a modular biomanufacturing platform that leverages single-use technology, controlled environment modules and advanced process automation. The paper outlines the strategic advantages and benefits of the flexible factory concept for biomanufacturers, including unequaled gains in speed to market, economics, risk mitigation, and flexibility.

Download the white paper, “The Flexible Factory Concept: A Flexible Bioprocessing Platform to Meet the Changing Needs of Biomanufacturing, from http://www.xcellerex.com/flexpaper. 

About Xcellerex, Inc.

Xcellerex, Inc. (http://www.xcellerex.com) is commercializing turnkey biomanufacturing solutions that transform the speed and economics of producing therapeutic proteins, including biosimilars and vaccines. The company’s FlexFactory® is a complete modular and portable production train based on single-use technologies, advanced process automation, and compact clean room architecture.

FlexFactory allows deployment of GMP manufacturing capacity more rapidly and at greatly reduced costs compared with traditional facilities. Through its BridgeSourcing™ services, Xcellerex manufactures a partner’s biomolecules while the partner prepares for commissioning of its own new FlexFactory. When the partner’s facility is ready, Xcellerex deploys its TransPlant™ process to install, validate and train partner personnel in their own FlexFactory. This parallel-path model both accelerates time to clinical and commercial manufacturing and allows partners to manage the development and market risks associated with adding manufacturing capacity.

Xcellerex also leverages its proprietary single-use technologies through the sale of XDR bioreactors, XDM Quad Mixers, and related single-use assemblies. To date, more than 20 therapeutic proteins and vaccines have been manufactured for clinical trials using Xcellerex technology.

Based in Marlborough, Massachusetts, Xcellerex is backed by an experienced management team and top-tier venture investors including Kleiner Perkins Caufield & Byers, VantagePoint Venture Partners and SCG Capital.


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