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

Posts Tagged ‘clinical trial material’


Tuesday, July 9th, 2013

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

AGAWAM, MASS. — July 9, 2013 — 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.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

“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.

To download the new, free white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

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).

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

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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.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

“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.

To download the new, free white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

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.

The white paper is available for download from: http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

“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.

To download the new, free white paper, “Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need,” visit http://www.microtestlabs.com/clinical-trial-material-production-testing-paper/.

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


Friday, April 30th, 2010

Microtest Labs Provides Complete Fill and Finish Manufacturing Services for Clinical Trial Material

microtest-logo1

AGAWAM, MASS. – May 3, 2010 – Microtest Laboratories will highlight its newly expanded fill and finish manufacturing service for all Phases of clinical trials at the BIO International Convention, booth #1944, May 3-6 in Chicago.

Microtest is a leader in providing flexible, customizable aseptic processing and fill/finish services for all pharmaceutical producers conducting Phase 1, 2, or 3 clinical trials.

“Virtual companies and smaller pharma manufacturers with no infrastructure for manufacture can partner with Microtest to provide their clinical trial material to clinics in an efficient and timely manner. Large manufacturers that don’t wish to divert high-capacity production lines will find Microtest a fast, efficient, cost-effective alternative,” said Alex Mello, Director of Project Management, Microtest. “Manufacturers of any size will discover a partner in Microtest with all the specialized knowledge, experience, and facilities they need.”

Microtest provides the flexibility for all types of pharmaceutical and biopharmaceutical manufacturing. Microtest will formulate per the approved batch record, which may include mixing, agitation, heating/cooling, etc. Microtest can provide problem solving experience to any of the specifics of a manufacturer’s process. Post formulation, Microtest’s analytical capabilities allow for a full spectrum of available in-process tests to ensure that the drug product is formulated to the strict specifications set by the manufacturer. Post in-process testing, filtration occurs utilizing the manufacturer’s specified filtration system, redundant as applicable. The product is filled into the designated vial type/size specified by the manufacturer as well as stoppered and capped using the manufacturer defined container closure system. Product is filled, capped and sealed under an ISO Class 5 environmental area.

Post fill, the product undergoes full 100% manual visual inspection, which is quality-controlled post-inspection by a qualified operator by performing an AQL inspection. Product is labeled per approved labels and stored in Microtest’s fully validated material control department at a multitude of storage conditions.

“As Microtest is a leader in testing of pharmaceutical drug products, we offer the full release package on-site thereby ensuring the most expeditious release of the product,” Mello said. “The specification documents allow for maximum efficiency when the samples are taken and released to our QC laboratories – both QC Microbiology and QC Analytical. Our representatives can discuss the testing on any final drug product specification and determine the most efficient release strategy.”

Microtest fill/finish operations comply with both U.S. FDA and European EMEA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.

For more information, visit Microtest at the BIO International Convention, booth #1944, May 3-6 in Chicago. Or, visit the Microtest website at: http://www.microtestlabs.com/aseptic-processing/fill-finish/ or call 1-800-631-1680. 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


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