Outsourcing

Before designing cleaning procedures, it's vital to know all physical and chemical characteristics of the product ingredients.

These latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations

Achieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive. In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these guidelines more evident.

Simple practices can increase profit margins and ensure gas supply.

IT, payroll, manufacturing, and clinical-trial data management are key areas for growth in biopharm outsourcing efforts.

In addition to India and China, other Asian countries are establishing themselves as destinations for biopharma companies.

Avariety of forces are combining to fundamentally change the financial dynamics of the biopharmaceutical industry. The initial public offering (IPO) appears to be giving way to licensing arrangements with, and acquisitions by, major pharmaceutical companies.

Less than 35 percent of all biotech companies have sufficient finances to survive beyond one year.

Your company's job is to make biopharmaceutical products. Managing facilities is a function supporting the main task. General manufacturing companies discovered this long ago, but pharmaceutical producers have been lagging. Once you consider the outsouring of non-core activities like facility management (FM), office services, space planning, and utilities management, you can focus on core business functions that make profits.

During the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts.

Mass serialization, or the ability to store a unique serial number for each item, is the most useful feature of RFID tags.

Outsourcing is becoming increasingly widespread and essential in the biopharmaceutical industry. Its imprint on biotech world business and on the development of biopharmaceutical drugs is becoming ever more pronounced. It is estimated that almost one-half of biopharmaceutical companies contract out at least part of the production of their products. On the other hand, those companies that do not outsource production often contract out some of their development activities.

Contract manufacturers must plan for increased analytical resources in development and quality control.

The contract manufacturing sector has not enjoyed the success of preclinical and clinical businesses.

Speed of response, small-scale manufacturing and process flexibility will become increasingly important.

The bulk of a biopharmaceutical processing unit can be assembled with off-the-shelf components. However, special fabrications — especially fluid components — enable fabricators and manufacturers to meet critical construction deadlines and move projects forward with minimal or no delays.

In today's competitive and fast-paced environment, owner companies must get products to market quickly and efficiently. By redefining how they provide services and products, suppliers can enhance their value and help owner companies reap the greatest financial returns.

Project management is a specific set of skills and processes administered to meet the specific complexities of a project.

Life sciences firms haven't exactly been jumping on the offshore outsourcing bandwagon. But faced with unprecedented cost constraints, competitive pressures, and regulatory scrutiny, the industry needs new solutions to its business problems. Some experts think information technology (IT) "offshoring" offers a solid alternative; others question the idea.

Technology innovations aimed at increasing yields and shortening development times can be very cost-effective, promising to reduce the need for large capital investments while getting the client into the clinic much faster.

Outsourcing Report

Current productivity initiatives may be too little, too late ? a more drastic overhaul may be required.

Biopharmaceutical companies can access their suppliers? resources to reduce validation and compliance efforts.

BioPharm International and Tefen Ltd. have teamed up to provide you with information and tools from the BioPharma Operations Excellence Consortium.

Supplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.