04.07.21 -- Advice For Cell-Therapy Biopharma: Strategic Building, Tactical Outsourcing

Advancing APIs through the drug product-development life cycle is fraught with challenges. Development timelines are tight, so it’s crucial to determine early in the process if an API is a viable candidate for clinical testing. A key tool that has emerged to address these combined issues of tight timelines and complex molecules is precision powder microdosing in capsules. This paper describes the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.

While packaging design and development can vary significantly, experience has taught us there are several foundational elements that must be considered: the product journey, safety-stability-security, and brand enhancement. Central to each is the patient or consumer experience with the product at the end of the supply chain.

Realizing the full potential of viral vector-based therapies requires an understanding of the platforms currently available for recombinant adeno-associated virus (AAV) production as well as how to properly evaluate them.

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologics drugs. We offer steps you can take to help prevent aggregation.

Most lung cancer treatments are administered systemically — whether by injection, intravenous infusion, or orally — and often are poorly tolerated by patients. Local delivery overcomes the disadvantages, using well-established devices, such as dry-powder inhalers (DPIs), which can deliver medicine directly to the lungs. This article describes formulation and manufacturing considerations for development of dry-powder therapeutics and presents a case study where an approved drug, topotecan, is successfully formulated for DPI administration to the lung.

With increasing costs of clinical trials, and the advantages of being first to market, it’s time to take a closer look at your supply chain to ensure it delivers with speed, efficiency, quality, and within your budget. This article is a guide through numerous considerations to decide whether to build your capability, outsource it, or create a hybrid insource/outsource model.

We conducted a blind and independent “voice of the customer” industry survey to ascertain what impact COVID-19 had and was continuing to have on outsourcing decisions for those who sought CRO, CDMO, or both CRO and CDMO services in the global pharmaceutical industry. In part three of our series, we investigate the impacts on different customer segments within pharma and biotech client companies: those who sought to outsource only CRO services, those who sought to outsource only CDMO services, and those who sought to outsource both CRO and CDMO services.

Many promising drug development candidates never advance beyond the preclinical stage because of bioavailability and solubility challenges. Dr. Sundeep Sethia has dedicated his life toward overcoming this initial hurdle in the drug development process.

Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacture of both today’s and tomorrow’s complex oral solid dose (OSD) therapeutics.

With the move into clinical studies, emerging biopharmas turn the page to an exciting new chapter in their stories. This is a time of dramatic change, due in no small part to a rapid ramp-up in face time with regulatory agencies and the expectation of data transparency that ensues. Fortunately, the whirlwind of simultaneous activity that biopharma leaders might be seeing for the first time isn’t entirely uncharted territory. We caught up with several startup veterans for insight and inspiration on navigating clinical-stage regulatory considerations.

In this interview, experts discuss the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems and the crucial role that BD can play as systems integrator, delivering manifold advantages to its clients.

Giovanni Ortenzi, vice president of pharmaceutical development and chief technical officer at Adare Pharma, describes how pharma companies can leverage Adare’s unique CDMO capabilities and proprietary technologies.

CDMOs are seeing increasing requests for oligonucleotide production from small to commercial scale. The challenge for a CDMO partner is to cost-effectively, quickly, and easily scale up your oligonucleotide from research to commercial quantities, as well as to have the facilities in place to manage commercial scale quantities. In this Q&A, the resources and capabilities needed for a CDMO to seamlessly scale oligonucleotides from research to commercial manufacturing are discussed.

Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics. Now, with the spread of COVID-19 intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy.