Whitepapers

Do you face challenges in your scale-up process for granulation? Get your practical tips for successful scale-up for free.

Inclusive medicine removes barriers to clinical trials creating new trial efficiencies that amply science, enabling you to bring treatments to market faster.

This paper presents results from an orthogonal study using isothermal titration calorimetry measurements and biased molecular dynamics simulations.

Connected applications, advanced analytics, and AI have become essential tools in the pharma industry. Go beyond proactive quality management by tapping into your data’s hidden intelligence.

Supply chain woes existed long before the pandemic, and not many scientists want to spend time sourcing ingredients. There is a way to ensure you get the right active pharmaceutical ingredients, at the right cost, with the right plan to scale: partnering with an API procurement and supply chain specialist. Download our white paper to learn five reasons to outsource API procurement.

What if you could rely on one partner to source APIs, formulate and develop drug products, and manufacture at clinical and commercial scale? Rather than too many links in your supply chain, an end-to-end CDMO reduces layers of administration, gaps in knowledge, time, cost, and risk. Download our white paper to learn the five “must ask” questions to find the right CDMO.

When the patent on a brand-name dental paste expired, our client saw an opportunity to offer sufferers of painful oral lesions a generic alternative. Their product would drive down costs for patients while positioning the client’s business for success in a competitive market. With the FDA’s Abbreviated New Drug Application (ANDA) regulatory pathway leading the way forward, all they needed was a partner with experience developing and manufacturing unique semi-solid products. That’s when they found LGM Pharma. Read our case study.

This white paper from outlines the best steps to establish an efficient drug formulation development process to stay within budget and meet timelines. 

Effectively adopt and integrate CPV into existing production processes to optimize the increasingly pervasive continuous manufacturing ecosystem.

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.