Pharmaceutical excipients roundup

By Gareth Macdonald

- Last updated on GMT

Related tags Food and drug administration Stem cell

In-PharmaTechnologist's periodic round-up of events in the
pharmaceutical excipient space includes one product launch and two
regulatory developments.

NuSil's MED 323 USA-based silicon products developer NuSil Technology has launched a new water resistant dimethicone pharmaceutical excipient called MED-323.

The compound, which is a tri-methyl end blocked polydimethylsiloxane, is designed to repel water and has a variety of applications in the drug and cosmetics industries.

MED-323 meets with both US and European pharmacopeial requirements for dimethicones with a CentiStoke viscosity rating of 350, and is available in 5 and 55 gallon quantities.

NuSil said that it intends to submit a drug masterfile to the US Food and Drug Administration (FDA) in due course.

NuSil spokesman Stephen Bruner told that MED323 " lowers the surface energy of topical formulations, making them easier to spread across the skin ."

Bruner added that " the product is targeted as an excipient for topical pharmaceutical formulations."

He went on to say that MED-323, which is manufactured at NuSil's FDA registered manufacturing facility in Bakersfield, California, will be supplied in tailored configurations to meet the needs of clients, but was unable to provide details of pharmaceutical firms already using the product for reasons of confidentiality.

In terms of NuSil's excipient development program, Bruner said that the firm is: " evaluating several options at this point but also invite customers to challenge us to develop and support products specific to their application ."

NuSil entered the market with its purchase of the simethicone business of GE Advanced Materials in September 2004.

Brian Nash, NuSil's vice president of marketing and sales, said that the launch of MED-323 is a further demonstration of the company's " unwavering support for the pharmaceutical industry ."

LyondellBasell completes HACCP certification Dutch polymer, petrochemicals and fuel specialist LyondellBasell Industries has completed hazard analysis and critical control points (HACCP) certification of management systems at its monopropyleneglycol (MPG) USP/EP manufacturing facilities in Fos-sur-Mer, France and Botlek, the Netherlands.

HACCP is primarily focused on preventing pharmaceutical and food safety hazards.

The system covers the entire production process from raw material procurement, manufacturing, storage, handling and distribution to eventual use of the finished product.

Patrick Quarles, senior vice president propylene Oxide & Derivatives, Chemicals at the firm explained that: " the proprietary program of operational excellence in practice at our manufacturing sites has proven a solid starting point for HACCP certification ."

Qarles added that, while LyondellBasell's MPG USP/EP product already complies with current good manufacturing practice (cGMP) standards, completion of the HACCP assessment allows the firm to " go one step farther and stand behind our management systems by committing to certify them.

As a member of the European Chemical Industry Council (CEFIC), we are committed to … safety and the principles of responsible care ."

Biolife's CryoStor masterfile accepted by FDA BioLife Solutions, a US developer of hypothermic storage and cryopreservation media, reports that the Food and Drug Administration has accepted a drug masterfile for its CryoStor product.

CryoStor is a ready to use preservative media for maintaining the viability and integrity of cells and tissue cultures when freezing and when transporting and storing at low temperatures.

To date, it has been evaluated by more than 100 cell therapy companies for the development of products targeting diseases including cancer, heart failure, vision loss, and neurologic disorders.

BioLife CEO Mike Rice said that: " we're optimistic that having an FDA Master File will also help accelerate product adoption in our key clinical markets, including cell therapy and cord blood and cell banking ."

He added that, while CryoStor is classified as an excipient, it is manufactured under medical device quality regulations and comprises only USP or the highest available grade components.

Rice cited market research by TriMark predicting that the stem cell products and services sector will be worth around $104bn by 2012.

A similar survey by PA Consulting estimates that the worldwide market for cell preservation media alone will grow from $200m last year to nearly $350m by 2011.

In related news, BioLife announced that US biopharmaceutical firm Oncolix has adopted CryoStor as its preservation media of choice.

Oncolix, which is based in Greenville, South Carolina is developing a cell-based therapy for the treatment of stage IV melanoma.

Michael Redman, Oncolix's CEO, said that the firm " evaluated other commercial cryopreservation media as well as an in-house formulation and found that CryoStor clearly offered post-preservation improvement in cellular yield and function."

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