Whitepapers

Large volume parenteral applications are characterized by high volume doses of a drug product, which are administered intravenously. Flexible bag systems, which contain a combination of different materials, are often used as container/closure systems. Definitions and regulatory requirements for extractables and leachables testing of large volume parenteral products, will be highlighted. Next, typical sources of extractables and leachables in flexible bag systems for parenteral use will be listed. Emphasis will be put on the specific challenges associated with large volume parenteral applications. Finally, some case studies regarding different designs of extractable studies will be discussed.

Meet the soloPURE™ flexible aseptic isolator, a cost-effective closed-barrier system for sterile manufacturing that provides a closed Grade-A, aseptic environment for fill finish activities requiring positive and negative pressures.

When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), one of the obvious questions is How far should one go into the E&L-qualification process? As the drug product is in a solid state, one would expect that the interaction between the LDP and the components of its container would be low. But is this really the case? Watch this webinar to learn more.

With the growth of highly potent active pharmaceutical ingredients (HPAPIs) and multiple-use facilities that must protect against product cross contamination, the need for engineering controls to achieve high containment has become more critical.

Learn about the benefits of using a DoverPac® Powder Containment System

From starting considerations to crucial factors, learn what matters most and what to be mindful of when selecting an ultra-low temperature freezer for your laboratory.

Assuring sample integrity and security in the biopharmaceutical workflow process is important to establishing standards that guarantee proper sample security.

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.

Product variability from biopharmaceutical manufacturing to storage can significantly impact the safety and efficacy of batch-to-batch products during clinical use.

A testimonial by Hubrecht Organoid Technology in Netherlands. An organoid research facility with an ultimate goal of regenerative medicine and cell therapy.

Making an effective vaccine faces obstacles which depend on a complete line-up of pharmaceutical-grade refrigerators and freezers to maintain the necessary conditions.

A significant advantage of MMTS™ Multi Mini Tablet System is the ability for patients and caregivers to open capsules and sprinkle the contents on soft foods.

Pressure for innovative products is becoming greater for pharmaceutical companies as they spend a significant amount on R&D and ways to achieve ROI in biopharma labs.

A testimonial from The National Center for Global Health and Medicine BioBank in Japan, a biobank to help develop leading next generation medicine and drugs.

A testimonial by The Inserm Unit, Institute of Regenerative Medicine Biotherapy (IRMB) in France, a facility dedicated to stem cell research and immunotherapy.

How 50 years of R&D and customer collaboration have contributed in the manufacturing of microbiological incubators to meet emerging applications in biopharma industry.

As biological products are being investigated as treatment modalities, measures to ensure safety and quality from microbiological contamination becomes imperative.

Companies looking to implement a quality management system (QMS) are faced with a dilemma: They can design a custom system from scratch or invest in purpose-built software. Before you decide which kind of QMS is the best fit for your needs, learn the pros and cons of each.

The catch-and-release platform Peptide Easy Clean, developed by Belyntic in collaboration with Bachem, enables the successful and innovative purification of peptides.

In this whitepaper, you will learn more about the different effects of accurate and reproducible temperature control on the condenser body regarding solvent recovery.

The pressure for innovative products is becoming greater for pharmaceutical companies as they spend a significant amount on R&D in all stages of clinical trials. Thus, optimizing efficiency becomes imperative.

As the biopharmaceutical industry gains momentum and biological products are being heavily investigated as treatment modalities, measures are needed throughout to ensure their overall safety and quality from microbiological contamination.

The changes during biopharmaceutical manufacturing, processing and storage can impact the safety and efficacy of products during clinical use. Controlling such product variability is a challenge to maintaining batch-to-batch consistency.

Assuring sample integrity and security during the development, manufacturing, and supply of biopharmaceuticals is one of the most important aspects leading to establishing standards that guarantee proper sample security.