Downstream Processing

A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.

How an electronics engineer led the first Indian company to carry out indigenous development of a recombinant vaccine.

Emerging therapies pose challenges for standardizing QC.

Two case studies illustrate a systematic approach.

The use of disposables has changed significantly in the biopharmaceutical industry.

The replacement of a IgG ELISA assay with an SPR-based test can shorten the production workflow by one day.

The recombinant approach lends itself to the production of an inexpensive and effective vaccine at large scale.

Potential interference with maternally-derived antibodies makes most vaccines less effective in the neonate.

Human HBV can be grouped into eight genotypes, which differ by at least 8%.

Microstructured transdermal systems can deliver a vaccine in close proximity to the antigen-presenting cells in the epidermis.

Design space concepts are key to a successful technology transfer.

How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.

The second of a two part article.

The challenge is not in coming up with a list of activities to discard, but in finding a feasible way to stop doing them.

The approval of a new seasonal influenza vaccine has further diversified the supply to the US market.

The US Food and Drug Administration has approved the use of the nasal influenza vaccine FluMist in children ages 2?5.

Sanofi Pasteur (Lyon, France) has announced positive results from Phase 2 trials of its dengue vaccine candidate based on technology licensed from Acambis plc (Cambridge, UK).

Crucell N.V. (Leiden, the Netherlands) has discovered a set of human monoclonal antibodies (MAbs) that work to neutralize and protect against H5N1.

Sanofi Pasteur (Lyon, France) has produced data showing that its new investigational H5N1 pandemic influenza vaccine containing a proprietary adjuvant achieved a high immune response at the lowest dose of H5N1 antigen reported to date.

The US Patent & Trademark Office has issued the fifth US patent to MorphoSys AG (Munich, Germany) stemming from MorphoSys’s base HuCAL (human combinatorial antibody library) patent family, providing extended protection to MorphoSys’s core technology.

Five European organizations, including three companies and two hospitals, have joined forces to develop a novel pandemic influenza vaccine as a potential emergency vaccination.

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.

In one series of experiments, the glycosylation site of IgG1 was removed and an IgA glycosylation site was introduced-resulting in a total loss of biological function.

It is hoped that HIV patients' own immune responses can be strengthened by vaccines so they will not have to rely exclusively on antiretroviral drugs.

Multivariate data analysis can help biotech manufacturers deepen their process understanding.

In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.

From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.