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

Posts Tagged ‘Fill/Finish’


Tuesday, July 31st, 2012

Six Critical Areas to Ensure Regulatory Compliance in Aseptic Manufacturing are Outlined in New Management Brief

AGAWAM, MASS. — July 31, 2012 — An unscheduled inspection of an aseptic manufacturing process can hit a pharmaceutical company with the fury of a New England nor’easter. But a new management brief explains how a best-practice control and monitoring system can minimize the danger of FDA noncompliance.

In the aseptic manufacturing business, all processes must be best practice to ensure the process will comply with the regulations. If any are poorly designed, not utilized, or deviated from, then the entire aseptic manufacturing system is considered out of compliance. This means that the checks and balances of a quality system must ensure that the sterile environments and surrounding support SOPs truly are working and show no signs of trending towards failure.

The new management brief, “Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing,” outlines six critical areas that should be addressed to avoid the possibility of product contamination:

  • Training and professional development
  • Environmental monitoring (EM) procedures
  • Incorporation of single-use technology (e.g. needle/tubing sets)
  • Facility design and maintenance
  • Process simulation
  • Raw material control, preparation, and sterilization

“The FDA has been very critical of aseptic fill/finish companies whose manufacturing environments are out of trend or outside of specifications,” noted management brief author Alexander (Alex) Mello, M.S., SM (NRCM), the director of Project Management, Manufacturing at Microtest Laboratories, Inc., in Agawam, MA.

“Rigorous production system control and monitoring through data generation and analysis will pave the way for best-practice pharmaceutical manufacturing,” he stated.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. Founded in 1984, the company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Microtest’s unique single-source capability to provide testing and manufacturing solutions allows the company to support a full pharmaceutical or medical device product release. Our facilities in Agawam, Massachusetts, include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Wednesday, August 24th, 2011

New White Paper Examines Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You

AGAWAM, Mass.Aug. 24, 2011 — For pharmaceutical manufacturers, delays in starting a clinical trial program due to issues involving the manufacture of clinical trial material (CTM) and the associated fill/finish and release work can make even the most dogged project managers wince in pain. A new, free white paper recommends a proven process of evaluating a cGMP contract manufacturing organization (CMO) to deliver all the required processes needed to release CTM for clinical trial use.

The new white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” explores what pharmaceutical manufacturers must require from a CMO in terms of capabilities and expertise and the critical roles that the contractor must be able to assume in the clinical trial material manufacturing process.

“In order to keep clinical protocols on time and on budget in the CTM manufacturing process, it’s critical that the selected CMO has comprehensive capabilities that are both in-house and readily available,” notes Alexander Mello, author of the white paper and Director of Project Management, Manufacturing, for Microtest Laboratories, a leader in contract manufacturing, aseptic processing and full service pharmaceutical testing.

“Contracting with a CMO without complete in-house expertise will add unnecessary time to the CTM process. In these cases, performing a GMP audit of the CMO, plus all of the other companies (formulators, laboratories, labelers, etc.) that the CMO uses in the supply chain, will add significantly to the overall cost and time for the technical transfer of the product,” he explains.

The new white paper illustrates how the proper selection of a CMO can help meet product schedules and minimize potential restart activities. The paper reviews the roles that the CMO must be able to play in CTM process, from first steps through the completion, and details the key areas of Raw Materials, Formulation, and Final Drug Product (FDP).

The white paper also discusses how a fully-capable CMO will have the ability to perform all the required processes in CTM – including excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.

Mello, the author of the white paper, is Director of Project Management, Manufacturing, for Microtest Laboratories. Mello’s 15 years of experience span Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

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, visithttp://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.


Wednesday, December 8th, 2010

New White Paper Examines Clinical Trial Material Production & Testing: What Your Contract Manufacturing Organization is Not Telling You

AGAWAM, MASS. – For pharmaceutical manufacturers, delays in starting a clinical trial program due to issues involving the manufacture of clinical trial material (CTM) and the associated fill/finish and release work can make even the most dogged project managers wince in pain. A new, free white paper recommends a proven process of evaluating a cGMP contract manufacturing organization (CMO) to deliver all the required processes needed to release CTM for clinical trial use.

The new white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” explores what pharmaceutical manufacturers must require from a CMO in terms of capabilities and expertise and the critical roles that the contractor must be able to assume in the clinical trial material manufacturing process.

“In order to keep clinical protocols on time and on budget in the CTM manufacturing process, it’s critical that the selected CMO has comprehensive capabilities that are both in-house and readily available,” notes Alexander Mello, author of the white paper and Director of Project Management, Manufacturing, for Microtest Laboratories, a leader in contract manufacturing, aseptic processing and full service pharmaceutical testing.

“Contracting with a CMO without complete in-house expertise will add unnecessary time to the CTM process. In these cases, performing a GMP audit of the CMO, plus all of the other companies (formulators, laboratories, labelers, etc.) that the CMO uses in the supply chain, will add significantly to the overall cost and time for the technical transfer of the product,” he explains.

The new white paper illustrates how the proper selection of a CMO can help meet product schedules and minimize potential restart activities. The paper reviews the roles that the CMO must be able to play in CTM process, from first steps through the completion, and details the key areas of Raw Materials, Formulation, and Final Drug Product (FDP).

The white paper also discusses how a fully-capable CMO will have the ability to perform all the required processes in CTM – including excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.

Mello, the author of the white paper, is Director of Project Management, Manufacturing, for Microtest Laboratories. Mello’s 15 years of experience span Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

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.

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


Tuesday, February 24th, 2009

White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

AGAWAM, MASS. – February 24, 2009 – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.

The white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product” focuses on what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). It is available for download at: http://www.microtestlabs.com/control-environment.

Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

In the white paper, the authors:

  • Warn to test only when necessary to reduce interventions.
  • Explain to test using methods that give data as quick as fittingly possible to condense processing times.
  • Discuss how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (http://www.microtestlabs.com/), a contract manufacturer and provider of contract manufacturing testing services.

To download the white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit: http://www.microtestlabs.com/control-environment.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, 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.

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


Tuesday, June 3rd, 2008

Microtest Labs Doubles Microbial Identification, Analytical Services

AGAWAM, MASS. – June 3, 2008 – Microtest Laboratories (http://www.microtestlabs.com/) has doubled their microbial identification and analytical services with the purchase of an additional MicroSeq® Microbial Identification System.

The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

“With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.”

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.”

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

  • Contract Manufacturing
  • Pharmaceutical Testing & Validation
  • Medical Device Testing & Validation
  • Environmental Control and Testing
  • Water Validation
  • Mold Identification
  • Biologics/Virology

The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today.

For more information about Microtest’s analytical testing and related services, visit contact the Microtest on the Web at: www.microtestlabs.com/medical-device-testing or by phone 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc.


Monday, December 11th, 2006

Microtest Enhances Analytical Lab Services with Addition of Advanced Microbial Identification System

AGAWAM, MASS. – December 11, 2006 – Microtest has dramatically enhanced their analytical lab services with the installation of a new, advanced technology, MicroSeqR Microbial Identification System. The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. As one of the only testing labs in the area with this technology, Microtest is providing their customers with a significant competitive advantage. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Steven Richter, Microtest President. “Our new MicroSeq system enables our specialists to provide customers with consistent and rapid results that, unlike previous equipment, ensures that the issues and concerns that prompted our clients to undertake their testing are properly analyzed and resolved, thus putting their production back on track.”

“Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales,” said Dr. Richter.

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

  • Contract Manufacturing
  • Pharmaceutical Testing & Validation
  • Medical Device Testing & Validation
  • Environmental Control and Testing
  • Water Validation
  • Mold Identification
  • Biologics/Virology

The new MicroSeq system is 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today.For more information about Microtest’s analytical testing and related services, contact Dennis Champagne, Director of Lab Services, at 1-800-631-1680 or email dchampagne@microtestlabs.com, or visit Microtest on the Net at: www.microtestlabs.com.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, 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.

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Tuesday, November 14th, 2006

Microtest Offers New, Free White Paper: ‘Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake’

AGAWAM, Mass., Nov. 14 — Microtest has announced the availability of a new, free white paper titled: “Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake.”

Selecting and establishing an effective working relationship with an Aseptic Fill/Finish contract manufacturer can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue.

In this new white paper, in addition to providing guidance on the selection process, John Dobiecki, Vice President/General Manager, Microtest, reviews the common mistakes made by potential clients.

These common oversights and their remedies are sourced from his collective experience base that covers contract aseptic fill/finish and bulk drug manufacturing.

Microtest offers fill/finish contract manufacturing services, integrated with stability and testing services, that lower costs, improve quality, and compress time-to-revenue for pharmaceutical manufacturers.

With 15 years of experience in medical device testing, Microtest is a single-source manufacturing solution.

Microtest is based in Agawam, Massachusetts, USA. For more information, visit
http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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