Analytical Method Development

Bionique Testing Laboratories has been acquired by Asahi Kasei Medical and will join the company’s biosafety testing services unit.

The companies will focus on the rapid development of polymerase chain reaction assays for emerging pathogens and potential health threats, including biological threats.

Analytical methods need a boost to ensure quality control for cell and gene therapies.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.

The increased flow of data from laboratory studies requires a data management strategy to optimize study success.

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients.

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

A new membrane staining kit, ExoBrite, launched by Biotium aims to enhance the detection of exosomes through flow cytometry.

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.

Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

The future pipeline of complex novel biotherapeutics will require new approaches to analytical assessment.

Developing bioassay methods requires a new approach for cell and gene therapy drug development.

Chalmers University researchers have developed a method to label and track mRNA molecules.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.