White Papers for Pharmaceutical and Biopharmaceutical Manufacturing

• Phase-appropriate analytical method development

  Drug development requires an average overall investment of USD 1.5 – 4.5 billion and remains at high risk due to the huge attrition rate phase after phase [1; 2]. The pre-clinical development phase and the phase 1 clinical trial show the highest attrition rate due to toxicity or drug metabolism...

• A Guide to Outsourcing Single Use Systems

  This article highlights key drivers to outsourcing single use systems that can accelerate speed to market for new product development.

• Pharma Manufacturing Quality eBook Sponsored by Merit Solutions

  In pharma, quality is a high-stakes business — not only measured in dollars, but more importantly, impacting patient lives. This eBook will discuss what it takes to achieve consistent quality in a changing manufacturing landscape. Gain insight on: - How new AI applications can automate the...

• Uploaded From lab-bench to large-scale production

  In formulation development, the scale-up from a lab-bench production of small batches to a large-scale production due to a demand for bigger batches, e.g. for clinical trials or economic reasons, can often be challenging. Thus, the possibility to scale-up the manufacturing process is imperative...

• Counters for bottle filling: What are the problems and can we do something about that?

  When a label on a bottle says “100 tablets”, we assume there are 100 tablets inside, don’t we? Not 99 or 101, but exactly 100. To be more precise, it is expected that the bottle contains exactly 100 undamaged tablets of the same kind. Obviously, bottle filling technology must meet two bigger...

• The Importance of Customer Service in Pharmaceutical Contract Manufacturing

  With tightening regulations and rising costs, the pharmaceutical industry is being presented with a consistent challenge in the marketplace: Do more with less. As a result, pharma companies are reducing their internal capacities in manufacturing and R&D and are, instead, increasing their...

• Level and pressure measurement technology for the pharmaceutical industry

  In the biotechnology and pharmaceutical industries, hygiene, consistent performance and flexibility are decisive factors for efficient, as well as safe production with a high degree of automation. VEGA offers worldclass measurement technology for level and pressure. We are specialists in this area.

• The Advantages Of Robotics In Aseptic Fill Finish

  AST's experts weigh in on why robotic systems have gained popularity and the benefits they can add to your aseptic fill finish facility.

• Water hammer can and must be eliminated

  Water hammer can be so damaging to machinery and dangerous to human health that every effort should be taken to prevent the hazard. Also known as hydraulic shock, water hammer sounds like a mechanical noise and is sometimes perceived to be a valve slamming closed. In reality, it is a phenomenon...

• How Does USP 800 Affect Urology Practices?

  Two commonly used drugs in urology, Mitomycin and Gemcitabine, are included on the NIOSH list. As hazardous medications, USP 800 requires significant investment to safely compound and administer doses of these drugs. Edge Pharma developed a solution that solves this issue for hospitals, surgery...

• Contained Tablet Coating Success Story

  A customer contacted Freund-Vector asking for a requirement to coat tablets on a LDCS-Pro Hi Coater (150L batches) and needed contained loading, sampling and unloading of their tablets.

• How to Achieve Data Integrity in the Laboratory

  Lack of data integrity is the main reason for most FDA warning letters. For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available...

• Novel Non-Crystalline Materials Analysis: New Strategies to De-risk Amorphous Material Formulation D

  The latest approaches for characterizing non-crystalline (amorphous) materials and determining physical stability under typical storage conditions. Amorphous forms consist of disordered arrangements of molecules that do not possess a distinguishable crystal lattice. Different forms of a drug...

• Are Sterile Bioprocess Containers A Source Of Particulate Contamination?

  We suggest that containers which are not produced to a recognized standard of cleanliness are a potential source of contamination.’ This article discusses why this is a problem for biopharmaceutical and vaccine manufacturers, the nature and source of possible contaminants, and a readily...

• Making it clear – the water quality standards of NSF/ANSI 61 and 372

  To make the products safe for water distribution there must be protective barrier material, joining, and sealing materials. These materials will ensure that the water remains free from any contaminates that may be present on or in the metal, paint, gaskets, lubricants, etc. NSF/ANSI has...

• Aseptic Isolation - The Time is Now

  For many companies, especially those that have existing clean room implementations, the opportunity cost and associated risks to integrate an aseptic isolation system were simply too high. But — if we can go out on a limb to say it — the time has come to kill off the clean room.

• Dec Group Offers Customized DPI Manufacturing Solutions

  A dry-powder inhaler (DPI) is a device that delivers medication such as corticosteroids to the lungs through inhalation. DPIs are commonly used to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease. The powdered substances used for this purpose need to have a...

• SCALE-UP AND TECHNICAL TRANSFER FOR LYOPHILIZED PRODUCTS

  Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The...

• Russell Compact Sieve® provides solution to high-capacity containment sieving

  Engineering house combines high containment isolator with hygienic and efficient pharmaceutical sieving solution to provide customized unit.

• 6 Strategies To Stretch Your Limited Drug Supply For Clinical Studies

  A clinical packaging strategy that can successfully manage the supply of your expensive drug product throughout the duration of clinical testing is critical to the success of sponsor companies. This paper explores six strategies that can be used to maximize a short drug supply for your...

• Analysis of Two API Products Using the Opt-Diss 410 UV FIber Optics with Multi-Component Analysis

  This white paper explains the theory behind the MCA algorithm methodology. Then, used in tandem with in-situ fiber optics, the accuracy of the technique is demonstrated by recovering the concentration of two APIs in known mixed solutions. Finally, an example is given of accurately monitoring...

• The FDA expects organizations to have full visibility and control over their processes

  Expectations include: • Understanding products and processes in order to implement Quality by Design (QbD) into product development • Delivery of quality metrics for risk-based inspection schedules as proposed by a new quality metrics program • Shared responsibility for products manufactured...

• 4 ways for Serialization Success

  As the Drug Quality and Security Act’s (DQSA’s) Novem- ber 2017 deadline approaches for serializing saleable units of prescription pharmaceuticals, many pharmaceu- tical companies, particularly small to mid-size organiza- tions, are just embarking on the serialization journey. There are four...

• ‘Winged’ PACKAGE DESIGN RESULTS IN COST SAVINGS

  A SINGLE UNIT DOSE NASAL SPRAYER CARTON FOR FLU VACCINE PROVIDES A MORE COMPACT AND LOWER COST ALTERNATIVE TO BLISTER PACKAGING

• Why Do I Need a Cleanroom?

  The electronic, high-tech, semiconductor, pharmaceutical, aero space, medical and many other industries depend on cleanroom technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical companies, clean,...