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Expansions
MECO to Construct Biopharmaceutical Distillation Units

MECO (Sugar Land, TX) was awarded three contracts to construct what the company says will be the largest biopharmaceutical distillation units in the world. Seven MECO MSS vapor-compression plants will be built under these contracts with 3600–6000 gal/h of water for injection (WFI) capacity. More than 1000 MECO MSS vapor compression distilling plants are installed and operating worldwide.

MECO provides equipment to produce WFI and US Pharmacopeia purified water for biopharmaceutical processes. The company designs and constructs complete water systems for its customers.

BioConvergence Completes Expansion and Receives Safety Certification

BioConvergence (Bloomington, IN), a contract solutions provider to the biotechnology and pharmaceutical industries, completed a 21,000-ft2 expansion of its headquarters. The expansion includes ISO 8-compliant sampling and dispensing for active and inactive pharmaceutical ingredients. The expansion brings the total facility size to 71,000 ft2 .

The company also became the first life-sciences company in Indiana to receive certification from the state's Safety and Health Achievement Recognition Program (INSHARP). The INSHARP program recognizes small businesses that demonstrate exemplary occupational safety and health programs.

Surefil IncreasesCompounding Capacity

Surefil (Grand Rapids, MI), a contract manufacturer, added more than 12,000 gal of capacity to its hygienic compounding facility. The new capacity meets the company's quality standards. The stainless-steel equipment includes center and sweep-wall agitation, sanitary valves and process piping, variable-speed-control pumps, and cone-bottom vessels.

Surefil also developed a new control system for the expanded facility. Each mix vessel features full load-cell capability, controlled addition of selected raw materials, automated additions of US Pharmacopeia 29 purified water, and automated clean-in-place capability. According to the company, the facility increased product batch repeatability and consistency, reducing both batch production times and scrap.

Ground Zero Extends Regulatory Consulting Services to South Africa

Ground Zero Pharmaceuticals (Irvine, CA) added its first South African clients and dramatically increased the number of Australian and US firms and programs that it represents to the US Food and Drug Administration. The company assists clients with programs from mid-discovery through full-scale clinical development and approval.

Ground Zero Pharmaceuticals is a regulatory-affairs and product-development consulting firm that provides strategic and tactical support to the pharmaceutical, biologics, biotechnology, and medical-device industries. Its services include: regulatory representation and submissions; preclinical planning; clinical consulting; biostatistics; chemistry, manufacturing, and controls consulting; and medical writing.

Regulation
Best Formulations Receives TGA Certification

The Australian Department of Health and Aging granted Best Formulations (City of Industry, CA) Therapeutic Goods Administration (TGA) certification. The certification recognizes that the company's manufacturing standards comply with those established by Australia's Therapeutic Goods Act. Best Formulations now has official permission to export medicinal products to Australia.

Best Formulations is a contract manufacturer of softgels, tablets, capsules, powders, and teas. The company is licensed by the US Food and Drug Administration to manufacture pharmaceutical products.

People
Quintiles Names President of Consulting Business

Quintiles Transnational (Research Triangle Park, NC) appointed Jay D. Norman to serve as president of its expanding Quintiles Consulting business. Quintiles Consulting helps pharmaceutical, biotechnology, and medical-device companies maximize potential and minimize risk from early discovery through commercialization.

Norman has 25 years of experience in the consulting industry. He most recently worked for Diamond Management and Technology Consultants, where he was president and chief operating officer. Norman's background also includes positions at PricewaterhouseCoopers Consulting, McKinsey and Company, and Accenture.


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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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FDA Reorganization to Promote Drug Quality
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From Generics to Supergenerics
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