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Posts Tagged ‘aseptic processing’


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. The brief is available for download from http://www.microtestlabs.com/weathering-the-storm-brief.

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.

The new management brief discusses how. Download a copy of “Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing,” from http://www.microtestlabs.com/weathering-the-storm-brief.

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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Tuesday, January 10th, 2012

Microtest Laboratories Will Manufacture ImmusanT’s Nexvax2 Immunotherapeutic Vaccine for Expected Clinical Trial

AGAWAM, MASS. – January 10, 2012Microtest Laboratories has announced that the company will manufacture and provide supporting pharmaceutical testing services for ImmusanT, Inc.’s Nexvax2® immunotherapeutic vaccine for its expected upcoming clinical trial.

 In addition to manufacturing Nexvax2, Microtest will provide a full range of testing services to ImmusanT supporting its drug product manufacture, including method transfer activities, complete final product release testing, storage and stability.

ImmusanT recently raised $20 million in financing to advance the development of their technology, Nexvax2, for the treatment of celiac disease. Celiac disease is an inherited autoimmune disorder that is triggered by the consumption of foods containing gluten causing an immune response resulting in inflammation of the small intestine. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study.

“As a one-stop source of on-site pharmaceutical testing and manufacturing services, Microtest provides a fast, efficient, cost-effective — and risk-minimizing — alternative to subcontracting with a variety of providers at multiple locations,” said Alex Mello, Director of Project Management, Microtest Laboratories. “We deliver the flexibility, solutions, and problem-solving experience manufacturers must have to ensure the most expeditious release of their product.”

Microtest Laboratories provides flexible, customizable aseptic processing and fill/finish services – and a full-range of pharmaceutical testing services – for biotechnology and pharmaceutical companies of all sizes conducting Phase 1, 2, or 3 clinical trials. Microtest fill/finish operations comply with U.S. FDA and European EMA 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 the Microtest website at: http://www.microtestlabs.com/aseptic-processing/fill-finish/ or contact Alex Mello, Director of Project Management, at 1-800-631-1680, extension 121. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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.

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Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com


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/

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