February 15, 2015 (Vol. 35, No. 4)

Company’s Silica Advances Include Single-Use Columns and Custom Intermediates

To pursue opportunities in biologics, the pharmaceuticals industry is adopting more nimble manufacturing practices. It is streamlining development, producing smaller batches, and reducing time to market. Helping pharma reduce developmental drag is Grace Discovery Sciences, a business segment of W.R. Grace. Grace Discovery Sciences serves customers in all phases of drug development—discovery, preclinical testing, clinical testing, and commercial manufacturing—through its Discovery Sciences unit.

Discovery Sciences is largely about silica, specifically silica technologies and products that advance the performance of chromatography resins and pharmaceutical excipients. The Discovery Sciences unit is also active in contract manufacturing. Manufacturing services capabilities, recently expanded, focus on pharmaceutical intermediates.

Chromatography

“With over 900 monoclonal antibodies (mAbs) in development, accelerating clinical manufacturing is a critical need for our customers,” says Adam Grose, vice president and general manager of W.R. Grace’s Discovery Sciences unit.

“Most of the innovation in biomanufacturing has taken place upstream, accelerated by the growth of contract manufacturing organizations (CMOs) and their adoption of single-use technologies,” Grose adds. “With few viable cost-effective chromatography solutions in this area, downstream purification has become a bottleneck.

“For CMOs, it was critical that the innovation offered improved flexibility while minimizing cross-contamination. This is especially true for mAbs given the sheer volume and diversity of antibodies in the pipeline.”

Grace’s disposable ProVance® columns, for example, help close the bottleneck between upstream and downstream processing. Disposable solutions enable customers to choose the optimal column for each process while minimizing the risk of contamination. ProVance columns combine Grace’s silica expertise with Protein A and OPUS® column hardware from Repligen.

“This is the first time a truly disposable Protein A column has been introduced,” Grose asserts. “We’re excited to launch a product like this that addresses this unmet customer need.”

Grose contends that having a pre-packed separation solution helps labs become more productive. A pre-packed column, he says, eliminates the need for manual packing and speeds the overall purification process, reducing labor costs and the potential for contamination.

A case study in the Grace literature comparing the ProVance column with agarose indicates that the Grace column can reduce purification time by as much as 80% while reducing total operating cost by as much as 50%.


ProVance™ high-performance disposable chromatography columns can help bioprocessors meet growing demand for downstream purification. The columns, which are designed for GMP purification of monoclonal antibodies and are available in a range of sizes, combine W.R. Grace’s large-scale silica manufacturing and established quality systems with Repligen’s recombinant Protein A and OPUS® column hardware. [Repligen]

Excipients and Drug Delivery

As much as 70% of the compounds in pharmaceutical research and development pipelines are poorly soluble. Accordingly, notes Grose, the industry is focused on improving bioavailability.

“Formulators have turned to lipid-based drug delivery platforms to address this challenge,” he continues. “However, these liquid systems are difficult and expensive to formulate into solid dosage forms.”

To help formulators overcome this difficulty, Grace has introduced Syloid® XDP silica. It effectively transforms liquids to powders and enables solid dosage forms with higher loading levels.

“Pharmaceutical companies are looking for ways to extend the life cycle of their products through new formulations,” Grose adds. “Grace’s ability to optimize silica material is enabling innovative solutions for formulators.”

Intermediate Contract Manufacturing

Grace also custom manufactures chiral intermediates, amino acids, peptide fragments, and other specialty chemicals. The company is expanding its U.S. investment in contract manufacturing to “add new capacity and upgrade labs for cGMP release testing,” Grose indicates. The additional cGMP manufacturing capacity supports custom solutions as companies scale up from kilos to tons for specific intermediates.

The global nature of research and development and manufacturing poses certain challenges for biotech and pharmaceutical companies. One such challenge, according to Grose, concerns mAbs: “Most of the existing capacity is in North America, but most of the new investment is elsewhere.”

In those high-growth emerging markets, it is often challenging to find talent with the right mix of credentials and experience. Allocating talent, however, is second nature for Grace, which has 6,000 employees in 40 countries. This capability may advantage Grace’s clients.

“Our talent in the region can provide local support to our customers,” Grose states. “We [recognize] pain points and develop products to help customers meet their challenges.”

W.R. Grace, Grace Discovery Sciences

Location: 7500 Grace Drive, Columbia, MD 21044

Phone: (410) 531-4000

Website: www.grace.com

Principal: Fred E. Festa, Chairman and CEO

Number of Employees: 6,000

Focus: Specialty chemical company W.R. Grace, through its Discovery Sciences business segment, manufactures excipients and chromatography resins and provides contract manufacturing of intermediates.

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