Overview of custom API manufacturing services, from pre-clinical & clinical manufacturing to commercial manufacturing, offered by CDMOs, CMOs, & CROs.
Q1. What is custom API manufacturing?
Custom API manufacturing refers to the production of desired quantities of pharma APIs, intermediates, fine chemicals, small molecules, reference standards, impurities, and other drug substances. API production is carried out exclusively according to a specified scale, which may include large scale custom API capabilities or commercial scale APIs.
The amounts produced during drug substance custom manufacturing tend to be small, ranging from a few milligrams to about 10 kg or so, and can be carried out in-house or by contract active pharmaceutical ingredient manufacturers. An active pharmaceutical ingredient (API) is any substance or mixture of substances intended to be used as active ingredients in medicinal drug products. Active ingredients have direct effects in the diagnosis, cure, mitigation, treatment, and prevention of diseases.
Pharma APIs and raw materials are often confused due to the similar usage of the two terms, however, raw materials refer to the chemical compounds used as a base for API production. The API production process is not completed in a single step, but rather via several chemical reactions between raw materials. The chemical compound which is in the process of becoming an API from a raw material is called an intermediate.
Intermediates are the building blocks of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates are by-products of API synthesis. Furthermore, these pharmaceutical intermediates are produced during each and every reaction of API synthesis. The intermediates are then used in API production for bulk drugs and also for contract research and development (R&D) purposes by various pharma companies.
Fully integrated contract development and manufacturing organizations offer cGMP API manufacturing services from small scale cGMP contract manufacturing of API to large scale custom API capabilities. Many of the CDMOs and CMOs offer small scale cGMP contract manufacturing of active pharmaceutical ingredients or custom synthesis of small molecules as a contract research project or as a custom synthesis project.
The integrated cGMP API manufacturing services allow small scale cGMP contract manufacturing of APIs, from inception all the way through to clinical custom manufacturing and can even advance to production at a commercial scale. Custom API manufacturing or drug substance custom manufacturing ultimately provides the platform necessary for clients to accelerate time to market for finished dosage forms (FDF).
Various pharmaceutical contract development organizations (CDMOs) can take projects from initial process development and scale-up through final validation and manufacturing at a commercial scale, by applying the appropriate drug manufacturing strategies and custom API manufacturing services. Custom API manufacturing services involve - Manufacturing of High Potent APIs (HPAPIs) or HPAPI custom synthesis, Key Starting Materials (KSMs), Registered Starting Materials (RSMs), key GMP intermediates, commercial scale APIs, etc.
Q2. What are the different capabilities involved in drug substance or API custom manufacturing?
Drug Manufacturing Strategies Involved in API Custom Manufacturing:
Step 1: Physicochemical Studies In this stage of API synthesis, the physicochemical properties of a drug substance are characterized and established. Every drug substance has intrinsic chemical and physical properties which need to be considered before latter drug manufacturing strategies can be conducted at a larger scale.
Physicochemical studies include:
- Selection of suitable drug substance candidates for API production
- Planning API and drug substance custom development & manufacturing processes
- Advancement of analytical development cGMP API manufacturing services
- Assignment of pharma API retest periods
- Synthetic route scouting custom API manufacturing services
Route Scouting & Route Optimization:
Synthetic route scouting, during early stages of process development and drug manufacturing, offers significant benefits by decreasing processing times, reducing the steps involved in process chemistry, improving quality and safety profiles, reducing chemical waste production, and improving scalability.
Route optimization can reduce costs, increase the efficiency of drug substance cGMP manufacturing, increase the safety of drug products, and accelerate the drug substance custom development and manufacturing process altogether.
Custom synthesis and route scouting go hand in hand, lately there has been an increasing trend towards achieving route optimization and all the benefits that the custom API manufacturing service imparts to the pharmaceutical product development process. Contract manufacturers provide such process chemistry, route scouting and route optimization - discovery and development services.
Step 2: Selection of Raw material: Active pharmaceutical ingredient (API) manufacturers take the raw materials, chosen during the early stages of drug substance development, and treat them in a reactor to obtain the required intermediates.
Step 3: Intermediates are purified to obtain individual drug products via sedimentation, filtration, centrifugation, crystallization, etc.
Step 4: Standards- The products that are obtained as a result are checked for their strength. Each pharmaceutical company employs different standards to measure the strength of its API.
Step 5: Physicochemical studies, reactor treatments, and purification are followed by scale-up custom API manufacturing services. Scale up is generally defined as the process of increasing batch sizes. In process scale up, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacturing that affects the orderly transition from laboratory to routine processing of commercial scale APIs in a full-scale production CDMO facility.
Q3. What are the key features of cGMP API manufacturing?
Good manufacturing practices (GMP) and to be GMP certified means that the active pharmaceutical ingredient (API) manufacturer has demonstrated a strong regulatory commitment compliant with international GMP standards. The jump to cGMP manufacturing is never simple, producing complex molecules within specification for the first time in cGMP is fraught with potential peril at every turn.
API production has traditionally been done by pharmaceutical companies themselves in their home countries, but in recent years many corporations have opted to outsource manufacturing overseas to various CDMOs and CMOs. All the drug manufacturing strategies from selection of raw materials to commercial manufacturing of pharma APIs are performed under cGMP (current Good Manufacturing Practices) conditions.
GMP is followed to ensure that pharmaceutical products (drug substances or drug products) are consistently produced and controlled according to quality standards and to minimize the risks involved in pharmaceutical production. Key elements of GMP API manufacturing must be clearly defined, agreed and controlled in order to avoid misunderstandings which could result in unsatisfactory products.
Key Elements in GMP API Contract Manufacturing:
- Quality Agreement
- Adherence to manufacturing process
- Supplier Audit
- Release of manufactured product
- Documentation and archive
- Cleaning Validation
- Change control
Q4. What are the key attributes when performing cGMP scale up in custom API manufacturing?
Drug substances are needed for a large number of safety studies and clinical trials. Custom synthesis and manufacturing services to go from preclinical to clinical manufacturing, and finally to commercial manufacturing can be challenging.
It is essential that the drug substance manufacturing process, called scale up, is carried out to produce large quantities of active pharmaceutical ingredients. Additionally, when progressing a drug substance from milligram to kilogram scale, there are various characteristics of the drug substance that can impact formulation and need to be considered prior to implementing scale up.
Pharmaceutical GMP scale-up deals with a subject vitally important to the industry—the procedures of transferring the results obtained via discovery and development services, from laboratory scale to the pharmaceutical pilot unit, and finally to production scale under GMP (Good Manufacturing Practices) conditions.
Laboratory Scale: The early stage development phase, generally 100-1000 times lesser in quantity (milligrams) as compared to the production batch, takes place during the laboratory scale stage of formulation scale-up.
Pilot Plant: It is used to test the behavior of a product during small scale custom API development and manufacturing, before proceeding with large scale custom API capabilities at a commercial scale. Pilot labs often use kilo lab units to achieve low volume, test batches of active pharmaceutical ingredients.
It is also an important stage for hazard identification and toxicity testing of drug products in a quality controlled testing laboratory. The pilot plant stage is where a lab scale formula is transformed into a viable product by using practical custom synthesis services and manufacturing procedures.
GMP Production Scale: The last stage of scale-up (kilogram stage) is the production scale. Production batches are referred to as the 100X batch and this is the scale at which fully integrated contract research organizations, and more importantly contract development and manufacturing organizations, run during routine marketing of products.
Fully integrated contract manufacturers, for API and molecule development, have the custom synthesis expertise to provide GMP scale up services at the laboratory and pilot scale of drug development.
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Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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