Newsletter | October 13, 2021

10.13.21 -- Should You Build Where You Buy? A Rarely Discussed Model For Biopharma

From The Editor
Featured Editorial
Industry Insights
"Validation" Or "Qualification": What’s The Difference?

What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

SimpliFiH Solutions For Accelerated Pharmaceutical Development

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

8 Misconceptions About Embedded CDMOs

Access to the expert capabilities of embedded CDMOs is offering great economies and competitive experience to the sector.

A Tale Of Two CDMOs: Which Choice Will Your Biopharma Make?

Today’s growing biologics challenges make the choice of a CDMO critical. You need a trusted and experienced partner from DNA sequence to commercial launch and at each checkpoint along the way.

Systematic Approach To Early-Phase Sterile Drug Product Technology Transfer

How should a manufacturer prepare for the initial transfer of a lab-scale process to the manufacturing plant? The more systematic the production approach and the more coordinated the effort between formulation scientists and manufacturing personnel, the more likely it is that the transfer will be successful.

Taste-Masking: A Unique Solution To Improve Patient Compliance

Taste plays an especially important role in pediatric medications, but it can affect adult compliance as well. No matter your age, if you have poor-tasting medicine, you’re more likely not to take every dose.

Aseptic Filling Operations: Keep In-House Or Outsource?

Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development. 

Minimizing API Supply Chain Risks

Partnering with an API CMO can help you navigate challenges you may encounter, ensuring you are using best quality practices and minimizing delays in getting those medicines to market.

Is There Really Less Risk In Selecting A Large CRO?

Most quantitative and qualitative studies seeking to understand what creates fear and anxiety in humans conclude with some version of the same four key criteria: lack of control, large consequence, sudden occurrence, and unfamiliarity. In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair contract research organization, is quite daunting.

It Hasn’t Been Easy For Pharma To Be Green

m Most of the drugs coming to market today are acquired by large or midsize pharma companies from small biotech companies. Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.

API Experts: A Small Molecule’s Journey Through API Development

Developing a small molecule API is often a perilous process for new and emerging pharma companies. Three leading API experts discuss the key challenges, what your company needs to succeed, and how partnering with a capable CDMO can make the biggest difference of all.

Partner Perspectives To De-Risk Commercialization Of Combination Products

Developing an effective drug-device combination product for self-administered biologics is a complex process. A well-executed strategy will help support integration with manufacturing operations and successful drug delivery.

Navigating The Path To The Clinic And Beyond For Gene Therapies

A gene therapy’s path from the research lab to the clinic and, ultimately, the market requires manufacturing processes that will meet regulatory requirements and the logistics to get therapies to clinical trial sites.

Outsourced Pharma Live
Best Practices For Outsourcing Process Development
Perhaps no outsourcing service better determines your drug program’s ultimate success than process development (PD). But PD covers a wide range of specific and timely needs. Particularly if you aren’t a process chemist, can you identify key components for working with CDMOs on this crucial step?