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

CRISPR-edited EML4-ALK Isogenic Cell Line

Metewo Selase Enuameh, Ph.D., Lysa-Anne Volpe, M.S., Michael Jackson, Ph.D., John Foulke, M.S., Luping Chen, B.S., Brian Shapiro, Ph.D., Fang Tian, Ph.D, ATCC

Cancer researchers are challenged by the lack of precise disease models. Genome editing was used to create an isogenic lung cancer cell line that was tested for drug sensitivity.

Continuous twin screw extrusion system for soft gel casing replaces batch mixing operations

Leistritz

Soft gel capsules are dosage forms that have an oblong and smooth casing that encapsulates a liquid. The soft gel casing (or gel-mass) is formulated by mixing together gelatin (or alternative material) with water, plasticizer and other ingredients. Historically, soft gel casings have been prepared in a batch mixing operation that takes many hours to complete.

Applications in Pharmaceutical Manufacturing

Alconox Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

Details Make the Difference for Successful Disinfection

Chip Burnett, Contec, Inc.

Disinfection is not just about the disinfectant. The details, tools and protocols implemented in a facility determine if a disinfection program is successful. This paper reviews the details that are often overlooked but can make a big difference.

JPEO-CBRND Supports International Partners in Congo Ebola Outbreak

Hannah Feldman and Rachel Overman, JPEO-CBRND, Joint Project Manager, Medical Countermeasure Systems

Teams from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND, provide continuing support to the Ebola virus outbreak response in the Democratic Republic of the Congo, or DRC, and neighboring countries.

How Can You Avoid the Fallout From Incompatibility Between Your API and Its Formulation?

Matthew Jones, Sr. Scientist, Thermo Fisher Scientific

Designing a formulation for a drug product calls for careful attention to both the physical and chemical properties of the active pharmaceutical ingredient. Find out how a pharmaceutical company can recognize both unfavorable drug substance properties and incompatibility between an API and its formulation to avoid potential risks to the patient and more.

The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing

Patti Seymour, Tom Ransohoff, Dawn M. Ecker, Howard H. Levine, Thermo Fisher Scientific

ORC International’s report Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing explores causes, consequences, and potential solutions to forecasting challenges related to biopharmaceutical drug substance manufacturing. It provides insight and perspective on key themes that emerge from the report, offering additional solutions to prepare for inevitable forecast inaccuracies.

Size Doesn’t Matter … Under Pressure

Gary Bubb, SMI

This whitepaper will evaluate the properties of different tablet sizes through normalization. This will be accomplished by using compression pressure rather than compression force and tensile strength versus breaking force (hardness).

The Case for a Purpose-Built Pre-Validated Pharma LIMS

Bob Voelkner, LabVantage Solutions

Learn how you can bypass lengthy customizations by deploying a purpose-built LIMS. Pre-configured, pre-validated lab information management systems save time and money, reduce risk, keep you focused, and future-proof your lab.

Finding Fakes – using Raman imaging to identify counterfeit medicines

Renishaw

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

Containing Cytotoxic Product during Transport

Cameron Faulconer, Flow Sciences, Inc.

The purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure.