Building Technology Positions in API Manufacturing - Pharmaceutical Technology

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PharmTech Europe

Building Technology Positions in API Manufacturing
As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.


Pharmaceutical Technology
Volume 35, pp. s10-s14

In August 2011, ProBioGen and Boehringer Ingelheim signed a nonexclusive licensing agreement regarding ProBioGen's GlymaxX technology, which is used in the production of afucosylated proteins. Boehringer Ingelheim's contract-manufacturing business will apply the technology to enhance the antibody-dependent cell-mediated cytotoxicity (ADCC) activity of antibodies. Both parties agreed to jointly market the technology and to offer it to customers royalty free. The GlymaxX technology prevents the addition of the sugar fucose to N-linked antibody carbohydrates. The absence of fucose enhances the ADCC. The GlymaxX technology is based on the introduction of a gene for an enzyme that deflects the cellular pathway of fucose biosynthesis.

BioVectra recently expanded its cGMP contract microbial fermentation services at its facility in Charlottetown, Prince Edward Island, Canada. The new manufacturing suite is for the clinical production of fermentation-based APIs and doubles the company's capacity to handle clinical-stage projects to 1500-L scale and related downstream-processing services.

Earlier this year, Neuland Laboratories launched expanded commercial-scale peptide-production services. The company produces peptides using standard sequential chemical peptide syntheses and segment-condensation strategies. The company uses solid-phase peptide synthesis procedures as well as solution-phase methods for shorter length peptides and segment condensation and ligation techniques for long peptides.

Small-molecule positioning

Several companies are expanding their capabilities in small-molecule manufacturing. In April 2011, the custom-manufacturing arm of Dr. Reddy's Laboratories expanded its Chirotech Technology Center at Cambridge Science Park, United Kingdom. The new 33,000-ft2 facility will double the scientific staff and allow for further capacity additions, including capabilities in biocatalysis, chemocatalysis, and other fine-chemical activities.

In January 2011, Aesica Pharmaceuticals completed its acquisition of three manufacturing sites in Germany and Italy from the biopharmaceutical company UCB. Aesica acquired the German sites in Monheim and Zwickau, as well as UCB's Pianezza, Italy site. The companies also formed a long-term supply agreement. Aesica also recently invested in a new high-containment facility in Queenborough, United Kingdom.

In February 2011, Saltigo reported on its work in catalyzed coupling reactions, including Buchwald–Hartwig aminations. Buchwald–Hartwig aminations entail the synthesis of carbon–nitrogen bonds through the palladium-catalyzed cross-couplings of amines with aryl halides. The company is involved with the industrial manufacture of special phosphine ligands. At its site in Redmond, Washington, the company recently scaled up the synthesis for Buchwald–Hartwig ligands, biphenyl monophosphines, such as tert-butyl-XPhos, tetramethyl-t-butyl-XPhos, and BrettPhos, for quantities needed for custom synthesis.

"It is usually relatively easy to scale up these kinds of amination reactions once the reaction has reached industrial scale," explained Björn Schlummer, chemicals process manager in Saltigo's pharmaceutical business line, in a Feb. 3, 2011, company press release. The company demonstrated that highly substituted anilines and aryl halides can be coupled efficiently, as demonstrated by the example of a diarylamine that was recently produced in a volume of 630 L.

Almac is investing $4 million in biocatalysis R&D. Research areas include new biocatalytic platforms for producing chiral intermediates, hyperactivation of biocatalysts for reducing enzyme loadings, developing drivers for cofactor recycling, and mitigating problems with equilibriums. Almac provides API manufacturing, formulation development, clinical-trial materials, and commercial manufacturing. In May 2011, Almac opened a new $120-million, 240,000-ft2 North American headquarters in Souderton, Pennsylvania. The new facility offers integrated clinical packaging, drug-supply management, and technology services. The facility has analytical laboratories that complement existing facilities in Craigavon, United Kingdom. The company also added in 2010 a dedicated late-stage customization site to its commercial facilities to assist in orphan-drug and niche-product launches in Europe.

Evonik recently reorganized its fine-chemicals and custom-manufacturing activities. The company combined its custom-manufacturing business (i.e., exclusive synthesis) with its businesses for pharmaceutical amino acids (i.e., its Rexim product line), and pharmaceutical polymers in a new healthcare business, effective Sept. 1, 2011. In June 2011, Evonik increased its production capacity for the pharmaceutical amino acid glycine by 50% at its facility in Nanning, China. The company also acquired the glycine business of the Tessenderlo Group in 2010.


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