Whitepapers

Optimizing API Procurement. 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.

WuXi Sta outlines clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.

Review testing requirements for lab balances in the pharmaceutical industry described in the relevant pharmacopoeias and the associated certificates offered by Sartorius.

This technical brief will start by outlining the importance of cross-coupling catalysts in the industry. It will then weigh up the benefits of existing in situ and pre-formed catalysts. The remainder of the technical brief introduces Johnson Matthey’s DyadPalladateTM pre-catalysts as a cost-effective and greener alternative to traditional in situ systems.

Peptide modification via salts is a way to change properties of the API to make it more advantageous to the desired release profile.

A long-acting injectable improves the patient’s experience by only requiring a once weekly, or monthly injection as opposed to a daily dosing regimen. The gel depot formulation is simple to manufacture, and easy to tune to the desired release duration and dose.

The recently introduced NanoFlowSizer instrument employing novel ‘Spatially Resolved Dynamic Light Scattering’ (SR-DLS) provides a breakthrough in inline nanoparticle sizing

We demonstrate the wide range of customized products and services that Actylis offers its biopharma customers.

We showcase Actylis, what the company stands for and how we serve our broad-ranging customer base globally.

We look at the importance of finding suppliers able to develop and customise Process Intermediates to meet the rapidly-changing expectations of modern finished drug manufacturers, and the economic & logistic benefits of outsourcing Buffer manufacturing, especially with the rise of cell & gene therapy products.

In this whitepaper we explore the role of GMP-grade Phenylmethylsulfonyl fluoride and other protease inhibitors in biopharmaceutical manufacturing, and we outline how Actylis’ high-purity and refined PMSF helps finished drug manufacturers to meet increasingly rigorous regulatory requirements.

We provide a list of readily available high-quality biopharma ingredients used for in vitro diagnostics, vaccines, cell cultures and preservatives that we keep on hand to service our biopharma customers. All these raw materials have a very short lead time to suit your rapidly-changing manufacturing needs.

Our in-house experts, along with Cecile Bellamy from Pfizer, deep dive into the factors that are influencing our industry today and look at what trends are likely to impact us in the future. We cover topics including regulatory compliance, manufacturer flexibility & supply chain risk and debate the supplier vs partner relationship and the importance of collaboration as we face a challenging future.

Read a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.

Biologics manufacturers have been successful boosting yields and increasing throughput in upstream mAbs production. Those increased volumes create a new challenge: scaling downstream process chromatography to be as productive. This Avantor white paper details how technologies such as a novel protein A chromatography resin and the use of additives can improve efficiencies in this complex process step. The white paper also explores the benefits of expanding single-use and continuous processing systems to further streamline downstream production and improve cost profiles.

A present investigation aimed to evaluate the impact of commonly used different binder-diluent ratios on the tablet's mechanical strength to propose a binder-diluent scale.

Pediatric formulations have become increasingly important as the healthcare field recognizes the huge impact that strict patient adherence can have on a treatment’s efficacy. But to overcome the challenges of adherence in children, drug developers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.

Process equipment used in the healthcare and pharmaceutical industries follow rigid specifications for accuracy, consistency and cleanliness.

Review testing requirements for lab balances in the pharmaceutical industry described in the relevant pharmacopoeias and the associated certificates offered by Sartorius.

Developing more effective chromatography resins for mAbs downstream processing is important ⏤ but it's not the only way to improve impurity clearance. In this study of the use of additives to enhance resin performance, two mAbs chromatography resins were examined. Both were used for a capture step, and additives were screened to reduce the nonspecific binding of impurities. The goal of the study was to optimize chromatography steps and thus increase the capacity and removal of impurities.

Newer, more complex targeted therapies are entering clinical development at rapid speeds, requiring facilities to increase manufacturing capacity levels in order to keep up with demands and under the strictest levels of containment.

In this application note, we show the reproducibility of gene expression measurements from Well to Well on 384-well TaqMan Array Cards, and Gene Expression assay panels.

Real-time qPCR: an established genomic technology in the discovery & development of therapeutic monoclonal antibodies.

Developing and manufacturing biologics requires compliant technologies and methods that provide excellent accuracy, consistency, and quality control (QC) with continuous automation potential to ensure the best possible product is delivered in the right time frame. PCR methods that enable quantification of target nucleic acid sequences—namely quantitative real-time PCR (qPCR) and digital PCR (dPCR)—have become core technologies for delivering high-quality results in a range of applications throughout biologics development and biomanufacturing. qPCR and dPCR methods are the gold standards for sensitive, specific detection and quantification of nucleic acid targets, which are useful for QC testing a wide variety of biologic characteristics.

We effectively demonstrate that TaqPath BactoPure Microbial Detection Master Mix is ideally suited for applications in biopharmaceutical manufacturing. TaqPath BactoPure Microbial Detection Master Mix enables consistent and sensitive detection of relevant targets in biopharmaceutical cell samples.