The Manufacturer Magazine : Promoting best practice in Manufacturing

Laureate Pharma, Quality and qualifications

Manufacturing in Action, Source : The Manufacturer US
Published : July 2007

Business is booming for bio-pharmaceutical contract manufacturer Laureate Pharma, Gary Toushek learns

Laureate Pharma, located in Princeton, NJ, is a full-service bio-pharmaceutical contract manufacturer that provides specialized bio-processing services to support the development, manufacture, packaging, and commercialization of protein-based products for its customers—pharmaceutical, diagnostic, and bio-technology companies. Laureate was acquired in 2004 by publicly traded investment firm/holding company Safeguard Scientifics, which considers their relationship a partnership.

Laureate’s services range from process design and development to full-scale cGMP (Current Good Manufacturing Practices) production, as well as purification, aseptic filling, testing, quality validation, analytical services, and regulatory support. Good Manufacturing Practice regulations are enforced by the US Food and Drug Administration. Adding “current” reminds manufacturers that they must employ up-to-date technologies and systems in order to be in compliance. The regulations require that manufacturers, processors, and packagers of drugs, medical devices, and food take proactive steps for a quality approach to manufacturing, ensuring that their products are consistently safe, pure, and effective—eliminating instances of contamination and errors—to protect the consumer from purchasing a defective, or even dangerous, product. It’s a system of workforce qualifications, sanitation and cleanliness, equipment verification, process validation, documentation, audits, reviews, approval releases, vendor approvals, change management, corrective action, and preventive action. Failure to comply with these regulations can result in serious consequences, including recall, seizure, fines, and jail time.

Laureate is focused on products in clinical trials or early commercial production in two active segments of the bio-pharmaceutical business: monoclonal antibodies and recombinant protein products. Its 57,000-square-foot facility contains laboratories registered with the FDA and licensed by the Drug Enforcement Administration and the Nuclear Regulatory Commission, and manufacturing areas that include several wave systems, hollow fiber bio-reactors, and stirred tank bio-reactors, ranging from 20 to 2,500 liters in size. Laureate’s cell line development team ensures that this first critical step in the development phase of a bio-pharmaceutical is improved and maximized to yield cell line productivity in optimal media for downstream processing. Laureate’s development staff takes protein-based parenterals from laboratory scale to pilot scale and to commercial production. Its team conducts small-scale pilot bio-reactor runs, a requisite step toward larger-scale production.

Growing bio-proteins in laboratories is a fairly complex process; in this case, mammalian cells are grown in the bio-reactors for the production of bio-pharmaceutical proteins. Those proteins are then purified by the most currently available semi-automated chromatography development systems, to scale up from bench to manufacturing, develop robust well-integrated processes, and produce high-purity product with good yield. The result is a seamless flow from sample preparation to initial capture, to polishing and final product formulation. Laureate’s protein modification specialists can perform chemical conjugation of molecules with proteins for clinical and commercial products, and they have a special expertise in working with the conjugation of chelators to proteins for radio-labeling.

Product is filled into vials under stringent aseptic conditions and finished according to customer request. A specialized filling machine, whose product contact parts are all single-use disposable, operates within a Class 100 cold-room area and accommodates vials ranging from

2 to 100 milliliters in size, with fill volumes from 0.1 to 100 ml; it can accommodate batch sizes up to 20,000 vials or 200 liters of bulk volume.

Analytical and microbiological testing is a routine but important process for raw materials, and for in-process and finished protein, as well as antibody and pharmaceutical products. The company is continually working with suppliers on the standardization and purity of incoming raw materials, as well as better inventory control. Laureate’s scientists routinely characterize protein properties, develop assays and test methods, transfer in customers’ methods, or adapt Laureate’s methods to customers’ protein products, according to requirements.

As well as its laboratory certifications and cGMP quality standards and procedures, the company’s overall quality assurance program includes stringent pharmaceutical regulations relating to microbiology and validation. The integration of its functional operations ensures compliance with the cGMP and manufacturing process, and the quality assurance department closely monitors the manufacturing groups to assure adherence to quality standards in all systems and processes.

Laureate has implemented as its validation program the Pharmaceutical Validation Master Plan (PVMP), a serious commitment, open to full scrutiny, that involves authorization, approval of content, and execution of the design qualifications, installation qualifications, operational qualifications, and performance qualifications of all its critical equipment. It’s a rigorous, heavily documented process. It also includes a revalidation program, customer-specific equipment, process validation, and in-house staff supervision of contractors and consultants. It involves declaring responsibilities, nominating team leaders, and serving those individuals with the full authority of the company. It documents the way the company operates, who has control over the various aspects of the validation activities, and how production, quality control, and workforce management are directed.

As well as the cGMP, the PVMP spells out Good Laboratory Practices as guidelines for quality control and quality assurance in testing laboratories, and it is integrated with cGMP. A globally recognized standard, the PVMP is intended primarily for laboratories carrying out analyses and evaluations of substances for regulatory purposes and includes evaluations of the safety of the pharmaceuticals.

The expense and efforts of its various quality programs and certifications seem to be a solid investment in the company’s future. A few months ago, adjacent to this facility, Laureate hired a group of new workers and opened its newly constructed $9 million expansion, a pilot plant for pre-clinical bio-pharmaceutical manufacturing, for engineering runs and production of product for uses such as formulation and toxicological testing. This new facility features two separate production suites and two expanded purification suites—stainless steel, stirred tank bio-reactors, and disposable, single-use bio-reactors—essentially the same technologies used in its facility next door, as well as a certain amount of on-site office space available to its customers. The expansion will enable Laureate to accommodate increased customer demand—because business has never been better.

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