Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

Analysis Using Counter-Rotating Twin Screw Extruder

Brian Machado, Abbe Haser, Feng Haight, Charlie Martin, Augie Zhang; Leistritz Extrusion

Various extrusion operating conditions and formulations were used to enhance the solubility and recovery of Meloxicam (MLX) in copovidone to near 100% on a counter-rotating twin screw extruder (TSE).

Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility

Arne Jendretzki; Baxter BioPharma Solutions

When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a contract manufacturing organization with experience in multiproduct facilities can be an option.

Battling Counterfeit Medicine Through Packaging Serialization

Mario Scigliano, Christian Ahlmark; CordenPharma International

This whitepaper explores informative packaging serialization requirements and deadlines with keys to combating worldwide drug counterfeiting. Topics include supply-chain serialization techniques like microscopic RFID tags, security labels, invisible inks, and track-and-trace technologies.

The Benefits of On-Dose Product Identification

Barry McDonogh, senior vice-president, Business Development; TruTag Technologies, Inc.

The introduction of on-dose product identification technologies provides the pharmaceutical industry with a powerful new tool to manage supply-chain risk.

Early-Phase Drug Development: Assessing, Predicting and Formulating with Delivery in Mind

Dr. Timothy Brannigan; senior chemist, Preformulation Physical Sciences; Almac Group

Development of new therapeutics demands substantial investment of time and capital, frequently with low chances of success. As a result, there is huge pressure to deliver reduced timelines and realize drug development programs. Scientists involved in development must balance opportunities to mitigate risk, and increase efficiency whilst maintaining quality. At Almac, we understand that developing therapeutics with a focus on delivery is fundamental to achieving success both in developmental phases and in the final product.

Solid Lipid Nanoparticles

Lubrizol LifeSciences

Solid lipid nanoparticles (SLNs) provide an effective tool for encapsulating and delivering both small-molecule hydrophobic and large hydrophilic APIs. SLNs are low cost, easy to manufacture, and versatile.

Risk Assessment for Single-Use Pharmaceutical Manufacturing Systems

Janmeet Anant, regulatory advocate; MilliporeSigma

Adoption of single-use systems adds a new layer of complexity to risk assessment. Single-use technology is now present in higher risk aseptic processing applications, such as the final sterile filtration step after formulation of the drug substance, and this can present new challenges for traditional risk assessment programs.
This whitepaper offers insight into current and expected industry and regulatory requirements for single-use pharmaceutical manufacturing systems, such as more detailed extractables and material qualification data. A review of single-use system quality and regulatory documentation based on these requirements is presented, which will make risk assessments based on ICH Q9 guidance more efficient for the sterile drug product manufacturer.

Cleaning Validation for Pharmaceutical Manufacturing

Alconox, Inc.

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

Five Keys to PAPR Selection

Douglas Durney; ILC Dover

Selecting powered air-purifying respirator (PAPR) systems for pharmaceutical manufacturing requires an assessment of performance, operator comfort, cost, and safety. This paper addresses five key areas to consider in any evaluation.

Finding Fakes—Using Raman Imaging to Identify Counterfeit Medicine

Renishaw

Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.