Manufacturing

Increased resin stability can extend the number of cleaning cycles that can be performed in situ.

The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.

If a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites.

Whether it's for manufacturing drugs, characterizing cell substrates, or regulating new technology, quality systems provide a needed framework.

We often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down.

It is important to ensure that flow decay during processing is comparable to that observed during retention studies.

Formulations for pulmonary inhalation comprise spherical, porous particles that are 1–3 microns in diameter.

Established, fully validated methodology and SOPs are required prior to initiation of any training activities.

The challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.

Steam traps are part of a steam-in-place system. The current design allots 18 in. of vertical leg for condensate backup. A design with a sensitive bellows has been proven in laboratory tests to need only 6 in. of vertical leg during the 15 min. of 121?C sterilization. Loads of 1 to 27 lb/h are covered by the capability of the new trap, equivalent to required steam for vessels 20 to 40,000 L.

Increasingly, pharmaceutical companies have recognized that software development is not their core competency.

Understand your company's requirements, define responsibilities,and manage your team effectively.

Case studies were run to test Process Analytical Technology applications for protein refolding, diafiltration, and cation exchange chromatography. It is shown that it is feasible to design control schemes that rely on measurement of product quality attributes and thereby enable real-time decisions.

Federal regulations are broad and open to interpretation. Most have not caught up with advancements in technology.

Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.

For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture-during fermentation, harvest, and early purification-to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting.

The approvals of two groundbreaking vaccines in the last month is encouraging news. Vaccines have long been undervalued because they haven't been as profitable as other pharmaceuticals. So it's good to see them getting deserved attention that goes beyond fears of flu outbreaks.

Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.

The lack of biomanufacturer acquisitions seems surprising.

A symposium at the AAPS National Biotechnology Conference in Boston, June 19-22, 2006, addressed key concerns and new developments in manufacturing biologic products in a sterile environment.

On August 12, 2003, Johnson & Johnson began recalling certain batches of its anemia drug, Eprex (epoetin alfa, sold as Procrit in the US), in most countries outside of the United States.

Several recent approvals highlight progress in developing both prophylactic and therapeutic vaccines.

The transdermal delivery of biologics-as well as of conventional drugs-is growing in popularity because the technique offers numerous advantages.

The purpose of the PAT initiative is to move analytical laboratory functions close to the manufacturing process to improve manufacturing efficiency and product quality.

Downstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.

The overhead expense that comes along with each new enterprise application adds up quickly, and can be somewhat invisible to owners of the system.

Air filtration also needs a filter integrity test method to guarantee the sterility of critical parameters.

Disposables can be used for media preparation, clarification, filling in downstream processes . . .

Certain areas of the vaccine market appear to be in vogue again, revitalized by blockbusters such as Prevnar, the pneumococcal pneumonia vaccine that reaped $1.5 billion in sales last year, and the human papilloma virus vaccines, which are projected to reach $4 billion per year.

Once guiding principles are identified, designers can explore the most cost-effective methods for delivering a flexible, expandable site.