Knowledge Hub

Operationalizing Customer Centricity to Exceed Expectations

Maintaining a customer-centric culture requires constant vigilance. The expectations of customers are always evolving, sometimes rapidly, in response to developments and market fluctuations. To be customer centric, pharmaceutical service providers must be attuned to changes in expectations and prepared to pivot quickly in response to them.

Pediatric Formulations: How Drug Developers Can Identify and Address the Unique Needs of Children

Developing formulations for pediatric patients poses unique challenges. The specific needs of children, which vary by age, mean the task goes well beyond just scaling down the dose of the formulation used in adults.

Challenges and Learnings from Industrial cGMP Manufacturing of Peptide APIs

Industrial cGMP peptide production has changed dramatically over the years. Today, peptide production happens on a scale that was unimaginable in the recent past, with demand driving companies to manufacture hundreds of kilograms of short chain peptides a year.

Eastern & Western Manufacturing Solutions for Late Life Cycle Products

The best manufacturing site for a product can change throughout the life cycle. When bringing new drugs to market, biopharma companies may benefit from keeping production in the US to localize the supply chain and ensure the speed of delivery.

How to Build & Manage Resilient Supply Chain

China emerged as the dominant player in the pharmaceutical intermediates and chemicals market in the early years of the 21st century. A combination of low manufacturing costs, government support, and other factors led to almost the entire pharmaceutical industry becoming dependent on China for raw materials.

Deploying Bioavailability Enhancement Techniques to Improve Patients' Lives

Oral bioavailability is a constant challenge for developers of new chemical entities. Low solubility and permeability often reduce the fraction of an orally administered drug absorbed in the bloodstream.

Mastering the Complex Delivery Technology of Liposomal Drugs

Liposomes can realize the full potential of drug molecules. By protecting the drug substance and changing its release profile, the lipid-based vesicles can enhance efficacy, minimize toxicity and overall improve the profile of the drug product.

Chromatography:Using a Versatile Interim and Fallback Tool to Solve Purification Challenges

Although other purification techniques such as crystallization are more scalable, chromatography remains an essential tool in pharmaceutical product development.

Aseptic Manufacturing of Parenteral Drug Products

Aseptic fill/finish is a crucial step in biopharmaceutical manufacturing, as it refers to the last step before a parenteral drug is packaged and ultimately delivered to the patient.

Modulating Atropisomers to Optimize the Biological Activity of Challenging Drug Molecules

Atropisomerism plays a crucial role in drug development. Molecules with the feature have become more prevalent in the R&D pipeline in recent years, creating both challenges and opportunities for innovator companies and CDMOs alike. The situation is driving demand for companies with mastery of the synthesis and purification capabilities needed to produce safe and effective atropisomers.

LIFE CYCLE EXTENSION:How Drug Developers are realizing the full value of their Molecule

Winning approval for a new molecular entity is just a staging post on the journey of a drug. To maximize the benefits of a therapy, drugmakers need to continue trying to improve the product life cycle and reach more patients after winning first approval

Ozonolysis:Efficient, precise and scalable oxidation

Oxidation reactions are a cornerstone of chemical synthesis. Medicinal chemists frequently use the method to functionalize molecules in lower oxidation states while protecting them from unintended transformations, such as potential side reactions. Yet, attempts to harness the reaction';s efficiency and precision at larger scales are complicated by safety risks associated with the oxidants. Due to hazards associated with oxidants, chemists often prefer other types of reactions at the process manufacturing scale.

PROTACS: Accessing the Expertise needed to Drug the Undruggable

Proteolysis-targeting chimera (PROTAC) molecules overcome a once-insurmountable drug development challenge. For years, researchers have known some proteins are implicated in human disease but have been unable to identify defined binding sites to unlock their therapeutic potential. PROTACs offer a way to target such “undruggable” proteins and improve patient outcomes, creating a need for teams with the synthesis and purification capabilities to support development of the molecules. 

saRNA from mammalian cell lines hek 293f and vero as a delivery system for gene therapy products

Self-amplifying RNA (saRNA) is a linear and single standard RNA delivery system that can deliver highly immunogenic viral genes and viral peptides to attain rapid and sustained immune response. The saRNA constructs that have been used for gene delivery or vaccine applications have been historically derived from alphaviruses.

Formulation Development Enabling Phase 1 Success

Drug developers need to get Phase 1 formulation development right. Without consistent Phase 1 materials, biopharma companies cannot gather reliable data that supports informed decisions about their drug candidates.

How Integrated Capabilities Accelerate Flow Chemistry Scale-Up

Flow chemistry has proven benefits. Compared to batch processing, flow chemistry is faster,safer and more sustainable — advantages that have made the technique an established part of drug development.

Oral Peptides: How Delivery Technologies are Unlocking the Potential of an Emerging Modality.

Therapeutic peptides are unlocking new, more effective ways to treat disease. Combining some of the key benefits of small molecules and antibodies, the modality has moved to the forefront of R&D over the past decade as new production, modification, and analytic technologies have advanced the field. Yet, the molecules have a notable weakness: they are naturally ill-suited to oral drug delivery. To overcome that limitation, Piramal Pharma Solutions has added advanced peptide formulation expertise and capabilities.

Assessment And Control Of Leachable Impurities - A Holistic Approach

Extractables and leachables (E&L) represent an important class of impurities in pharmaceutical products that can arise from interactions between drug formulations and packaging materials, manufacturing components, or delivery devices, and migrate into drug products during manufacturing, storage, or administration.

Biocatalysis: From Reaction Toolkits To Scalable Synthesis Applications

Biocatalysis is a central pillar of modern organic synthesis. Using enzymes or whole cells as catalysts, researchers deploy biocatalysis to synthesize molecules in mild, environmentally-friendly conditions with high selectivity.

Driving IP Security and Value Creation Across Integrated Drug Discovery Pipelines

Starting from a previously validated molecule is one of the fastest ways to reach the clinic, but the IP economics are unforgiving. Molecules that closely track prior art offer weak IP protection, and method-of-use claims often fail to defend a market position.

Advancing Peptide Manufacturing through Spray Drying Technology

Spray drying is a versatile pharmaceutical manufacturing technique that transforms liquid formulations into dry powders in a single step.

How In-House Starting Material Production De-Risks Drug Supply Chains

Starting materials are vital to the reliable supply of high-quality medicines. As critical building blocks of active pharmaceutical ingredients (APIs), these materials influence everything from product purity to supply chain security.

How Process Innovation Enables Cost-Effective Synthesis Of Complex Cyclic Peptides

The distinct biochemical and therapeutic properties of cyclic peptides make them an attractive alternative to small molecules and antibodies in some therapeutic indications. 

Greenness By Design: Strategic Integration Of Green Chemistry Principles In Early-Stage Synthesis

The pharmaceutical industry is increasingly encouraged to deliver innovative therapies rapidly while embracing sustainable, environmentally responsible practices that ensure efficiency and safety in drug development. 

China Plus One: How Resilience Is Reshaping Supply Chain Management Strategies

Supply chain resilience is a competitive advantage and an ethical imperative. Amid rising geopolitical tensions, risk-mitigation initiatives that began in response to regulatory changes in China have evolved into comprehensive supply chain resilience programs.

The Science Collective: Accelerating Drug Development Through Integrated Expertise

Drug development is increasingly complex, requiring rapid, informed decision-making throughout the product life cycle and across manufacturing sites.

Standardizing Project Management to ensure the Effective Delivery of CDMO Services

Project management is vital to the effective delivery of biopharma services. Outsourcing partners work upfront to ensure everything goes to plan but cannot assume projects will progress as expected.

Production of AAV2 Particles for Gene Therapy Applications

A deno-associated virus (AAV) vectors have been identified as the safest and most effective gene delivery vehicles in vitro in cultured cells and in vivo in animal models. 

Moving Beyond Cytotoxicity: A Mechanism-Oriented Framework for Cellular Assessment

Accelerating the design-make-test-analyze (DMTA) cycle that underpins all drug discovery programs offers a significant competitive advantage, helping drug developers reach the clinic and market before their rivals while also minimizing costs.

Integrated Services: Partnerships For Success

Efficiency, speed-to-market, and access to unique expertise are among the key benefits of partnering with a contract development and manufacturing organization (CDMO) offering integrated, end-to-end services.

How Integrated ADC Services are Accelerating the Delivery of Clinical Product

Accelerating the development of antibody-drug conjugates (ADCs) is critical to addressing unmet medical needs. The modality is transforming the lives of cancer patients by providing powerful anti-tumor effects without intolerable side effects.

Harnessing Light of Multiple Wavelengths for Chemical Transformations

Photochemistry, the study of chemical reactions initiated by light, has emerged as a powerful tool in modern chemistry. 

8 Essential Steps to Overcoming the Complexities of Oral Liquid Formulation

Oral liquid formulations are an essential drug delivery format. Easy to swallow, with a fast onset of action and high dosing flexibility, the formulations are widely used and particularly important to pediatric and geriatric populations.

HPAPIs & The Need For Well-Contained Chemistry

Highly Potent Active Pharmaceutical Ingredients (HPAPIs) continue to be a rapidly growing segment of the pharmaceutical industry.

How To Scale Cryogenic Chemistry From Lab To Launch

Cryogenic reactions are essential for synthesizing some active pharmaceutical ingredients (APIs). By working in cryogenic conditions, chemists can reduce impurities, ensure safety, improve selectivity, and facilitate reactions that are impossible at higher temperatures.

A Practical Guide To Lyophilization: From Formulation To Final Product

Lyophilization is a vital process employed to enhance the stability and extend the shelf life of drug products particularly Biologics and other complex modalities.

Inside The POD: A New System For Flawless Project Delivery

CDMOs are defined by project execution and delivery. Clients and patients alike need service providers to complete projects as quickly and efficiently as possible, adapting nimbly to unforeseen developments to consistently come in on time and on budget.

How High-Throughput Experimentation Accelerates Drug Development

High-throughput experimentation (HTE) empowers drug developers to quickly build robust platforms for scale-up. Facing constraints on their time, resources, and materials, companies leverage this approach to rapidly execute many miniaturized reactions in parallel to survey a wide range of possible reaction conditions.

Payload-Linkers Differentiate ADCs. Here's How to Access Leading-Edge Technologies

Why Wet Milling is Well Suited to Today's API Solubility Challenges

Patient Centricity: A Compassionate Approach that puts Patients at the Forefront of our Mission.

The Importance of Data Analysis in Solid-state Characterization

How Operational Excellence can Unlock Capacity in API Manufacturing.

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Mitigating Risks in Tech Transfers and Site Transfers