Overview of clinical supplies of APIs & intermediates & more on clinical supply manufacturers (CDMO, CMO) offering clinical services.
Q1. What is API clinical supply?
API clinical supply, or API clinical trial supply, is defined as the supply of Active Pharmaceutical Ingredients (APIs) required for clinical trials. The core of any good clinical supply chain system is supply management that addresses all of the nuances of clinical supplies production.
Clinical supply, or clinical trial supply includes 24-hour collection and delivery of biological specimens, investigational drugs, kits and other study materials such as APIs and Finished Dosage Forms (FDFs) along with cold chain services including temperature-controlled packaging, etc.
Clinical supplies (CS) can be a rate-limiting factor for the initiation of studies because of factors such as insufficient bulk material, inadequate forecasted demand, accumulation of delays (such as pharmaceutical manufacturing delays), or a sudden acceleration in the timeline for the study's start.
Compared to their commercial counterparts more advanced in the maturity curve, clinical supply chains face greater challenges from both demand and API supply perspectives. Furthermore, unpredictable patient enrollment leads to fluctuating demand signals, frequently causing supply disruptions.
Various pharmaceutical organizations including CDMOs (Contract Development and Manufacturing Organizations) which offer API manufacturing or API production and have clinical manufacturing capabilities can offer API clinical supply manufacturing and packaging services along with commercial cGMP manufacturing of APIs.
To ensure successful manufacturing of Active Pharmaceutical Ingredients (APIs) during clinical trials, it pays to work with a Contract Development and Manufacturing Organization (CDMO) or a Contract Research and Manufacturing Services (CRAMS) provider with deep expertise and experience in clinical trial molecules or APIs.
Such organizations can offer integrated API clinical trial material development and manufacturing services. The CDMO should uphold the highest current Good Manufacturing Practices (cGMP) to avoid cross-contamination or other factors that could impact the quality of the clinical trial supplies.
However, contracting with a Clinical Research Organization (CRO), CRAMS or Clinical Manufacturing Organization (CMO) may be more efficient for offering integrated API clinical trial material development and manufacturing services. They can take sponsors through every step of the way in the lengthy drug development process all the way through manufacturing and may have a strong record of getting required clinical trial materials ready in time for the launch of clinical trials.
Q2. What are the different API CDMO services from process development to clinical supply and commercial manufacturing?
Planning and managing clinical trials is an increasingly complex task. Unlike standard pharmaceutical supply chains, there are many unpredictable factors. Some key API CDMO services engaged with clinical trial supplies activities include: process development, API manufacturing, clinical supply manufacturing and packaging services, among others.
- Phase Familiarization
Phase familiarization is the first step which includes running experiments, spending several weeks or even months either replicating existing work or developing new chemistry routes to attain the final molecule.
- Process Development
During the development phase of API clinical supply, pharmaceutical companies are challenged with choosing a manufacturing process that ensures that APIs will reach clinical studies quickly and that they can be made using a cost-effective process.
To meet the demands of early-stage development, contract research organizations (CROs) and CDMOs can evaluate various dosage-form options and manufacturing pathways before selecting the processes that optimize the clinical manufacturing process. R&D and kilo labs support process development and sample preparation for drug substances including complex APIs for early stage clinical trials.
- API Manufacturing for Clinical Supply
API manufacturing for clinical supplies changes with demand, availability of drug substances, and study phases. A strategy must be developed clearly to effectively manage the complex clinical supplies manufacturing process. The process may begin with the manufacturing of R&D or scale-up batches of APIs followed by GMP clinical supplies manufacturing.
Furthermore, API clinical manufacturing includes planning, collaborative communication among the cross-functional team, lean manufacturing, effective training programs, and application of new specialized technologies to facilitate clinical supplies manufacturing or clinical supplies production.
- Scale Up & Technology Transfer
Next come scale up and technology transfer API CDMO services which are essential for successful API clinical supply. The development of pharmaceutical products from laboratory scale to large-scale industrial production involves numerous planning steps which includes scale-up at different levels.
The goal of scale-up is to identify and develop a process that will successfully produce a desired product when manufactured at a commercial scale. Technology transfer is what happens when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site or when they move from manufacturing APIs from one scale to the next.
- Clinical Trial Packaging
Highly specialized activities are needed for clinical trial packaging and distributing clinical trial supplies which are to be dispensed to patients in a timely and controlled manner.
These highly specialized activities include project management, randomization generation, clinical trial material labeling, blinding, pharmaceutical supply chain logistics, and destruction. Effective clinical trial packaging, clinical trial material labeling, etc. can make the difference between a successful clinical trial and a failed clinical trial.
Commercial Manufacturing & Supply
Once a viable active pharmaceutical ingredient (API) has been developed, and clinical trials have delivered promising results, scale up is carried out to produce commercial-scale batches of the drug substance at a larger scale, the commercial scale.
Commercial manufacturing involves commercial cGMP manufacturing of APIs at a production scale to facilitate the commercial supply of pharmaceuticals to the industry. After a large enough quantity of the product is produced it is ready for commercial supply.
Q3. What are the important things to know about API development and manufacturing for phase 1 & 2 clinical trials?
Clinical trials have a vigorous pharmaceutical supply chain management of drug products and drug substances considering the stringency of the regulations and the availability of infrastructure for efficient execution.
Drug manufacturers have begun to outsource their logistics and material supply requirements along with integrated full-services to third parties for efficient functioning of clinical trials. This has integrated the third-party vendors into clinical trial development and clinical supply chain management.
The new drug development process can be characterized into different clinical phases including phases I, II, III, and IV. From phase I to phase III, clinical investigation is one of the most important activities to prove the safety and efficacy of a new drug.
More specifically, phase I studies use clinical trial materials and supplies to test the safety of drug products, while phase II studies utilize clinical trial materials and supplies to test the efficacy of drug products.
API Development and Manufacturing For Phase 1 & 2 Clinical Trials:
Phase 1:
Phase 1 clinical trials represent the first phase in a long and complex drug development process. It is during this stage that a specific drug product's safety, efficacy and effects are benchmarked and determined. A phase 1 clinical trial introduces an investigational new drug into human subjects for the first time. For this reason, this phase is perhaps the most vital and challenging one for sponsors and their CDMOs alike.
Some pharmaceutical companies may choose to outsource phase I development of clinical supplies and API clinical trial material manufacturing services to CDMOs (Contract Development and Manufacturing Organizations). When choosing a CDMO it is important to use a single organization for the entire project, check if they have ample supply to meet your requirements, beware of low estimates, etc.
Phase 2:
When preparing for phase 2 clinical trial programs, one of the biggest challenges is scaling up to produce significantly more Active Pharmaceutical Ingredient (API) material than the amount needed for phase 1. Because phase 2 clinical trials are larger, with more participants, materials need to be scaled.
Important factors to consider include reviewing the chemistry before manufacturing at a large scale, making small engineering batches prior to manufacturing, and conducting analytical assessments, etc. Process research, kilo lab scaleup and analytical development are key to smooth transitions from phase 1 to phase 2, and for the preparation of phase 3 trials.
Various pharmaceutical organizations with API development and manufacturing capabilities may offer clinical development services for phase 1 and phase 2 clinical trials along with API clinical trial material manufacturing services and commercial cGMP manufacturing of APIs.
Q4. How does complexity impact the timeline, process and cost of turning a molecule into a drug for clinical trials?
Successful supply of clinical materials is key to assure that clinical studies are conducted as planned at the correct time with the correct dose and correct amount of materials. However, complexity impacts the timeline, process and cost of turning a molecule into a drug for clinical trials.
- Process
The process of complex drug discovery and development is long and expensive as many biological targets must be considered for every new medicine eventually approved for clinical use. Furthermore, new research tools may be needed to investigate each new target.
- Timeline
There are typically several chemical steps needed to make complex material for clinical trials. Even if one step has poor yield it can cause a huge setback in terms of time for pharmaceutical organizations. There never seems to be enough time, especially when it comes to developing an NCE.
True collaboration with a CDMO (Contract Development and Manufacturing Organization), CRO (Clinical Research Organization) or CMO (Contract Manufacturing Organization) can destress the process of preparing a drug for clinical trials.
- Cost
Complex studies present unique cost considerations. With such a large financial burden, many trials are underfunded, and may not have any reasonable opportunity to generate a positive outcome even if protocols are amended, at additional cost. Underfunded trials are by definition more likely to miss the enrollment needed to demonstrate statistical significance at a predefined level of efficacy.
Studies that contribute to solving any of the many scientific and operational issues involved in the clinical development process can improve the efficiency of the process. An awareness of these issues allows the early implementation of measures to increase the opportunity for success.
Working with CDMOs (Contract Development and Manufacturing Organizations) which function as API suppliers or API manufacturers allows partnering pharmaceutical companies to benefit from a long-term collaboration with an experienced team offering specific skills, equipment and technical resources that are not available internally, resulting in a robust clinical API supply chain, reduced risks and optimized costs for integrated API clinical trial material development and manufacturing services.
Q5. Which are the leading pharmaceutical companies offering clinical manufacturing for APIs?
Pharmaceutical innovators are today relying more on integrated full-service CDMOs (Contract Development and Manufacturing Organization) for the clinical and commercial production of their API (active pharmaceutical ingredient) and for API clinical trial material manufacturing services.
Solara Active Pharma Sciences - Clinical Supply Manufacturer
Solara offers API contract manufacturing for clinical supply - phase I, II and III trials and functions as a clinical supply manufacturer. They cover the entire life cycle of a new chemical entity at all scales, from pre-clinical and clinical phases. They have specialized technologies to offer chemistry services, which include lead synthesis, lead optimization and pre-clinical services.
Solara's CRAMS business also offer contract services for pharmaceutical products in phase I, II and III, which require process optimization and cGMP production. Further, it has the capabilities to assist customers in the commercialization phase of their products. Its contract manufacturing services and outsourcing services are primarily directed towards pharmaceutical manufacturing of complex APIs and intermediates.
PMC Isochem - Clinical Supply Manufacturer for Clinical Trial Services
PMC Isochem offers cGMP and non cGMP industrial exclusive custom synthesis and provides integrated full-services from pharmaceutical drug development to API production including clinical batch supply, clinical supply chain solutions and regulatory support. PMC Isochem's clinical offerings make them a partner of choice as a clinical supply manufacturer.
PMC functions as a CDMO for intermediates , excipients and API production and has 40 years of experience in custom manufacturing from R&D to clinical trial services and commercial supply. PMC Isochem offers research, product / process development, preclinical and clinical batches and commercial supply along with the development of APIs and Intermediates for major pharmaceutical companies worldwide.
Pfizer CentreOne - Small Clinical Batch Manufacturing
Pfizer CentreOne offers clinical and commercial production and can help take your molecule all the way from early clinical phases through to commercial scale production and lifecycle management. Its clinical trial services offerings include APIs and formulations, clinical manufacturing, analytical testing, validation and method development.
Pfizer CentreOne offers the development of APIs and Intermediates and manufacturing flexibility to support small clinical and commercial scale batches with their cGMP pilot facilities. It is a leading clinical supply manufacturer in the pharmaceutical industry.
Bachem AG - Peptide and Small Molecules APIs
Bachem is the world's leading independent manufacturer of peptide and small molecules APIs. Each year, Bachem manufactures hundreds of batches of drug substances for projects in clinical trials and for products on the market. Therefore it is an API manufacturer or an API supplier that offers both clinical and commercial production along with outsourcing services.
With 50 years of experience and expertise, bachem has specialized technologies to provide products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of contract services.
Eurofins CDMO - Pharmaceutical Manufacturing of Clinical Trial Batches
Eurofins CDMO (Contract Development and Manufacturing Organization) provides integrated, end-to-end clinical supply chain solutions, clinical trial material labeling and preclinical and clinical outsourcing services for both drug substance / API and drug product containing biologicals and small molecules.
Eurofins CDMO offers a full suite of drug development and manufacturing services encompassing pharmaceutical drug development services for bioprocesses, pre-clinical testing, and sterile and non-sterile bio-manufacturing of clinical trial batches through its specialized technologies.
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