Production timelines

With a tight production timeline, we chose to move forward with Silicycle Thiourea, which offered good Pd removal and filterability, albeit at a higher cost. In subsequent process development work the progress of Pd removal versus time was evaluated at both room temperature and 65°C. Results are shown in Figure 5.3 for 3 g scale reactions with 30% w/w Silicycle Thiourea. Pd removal was not only faster at elevated temperature but also more Pd was removed. 

Define production timeline for drug substance supplies for formulation development, stability, toxicology, and clinical studies. 

Planning requires detailed and ongoing assessment of your vendor. "Our project leaders meet quarterly with our vendor for ongoing reality checks of product timelines. The meetings help us identify the changes we need to make on our end to ensure that project implementation is successful."... 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

Initial scale-up of microbial biotransformation is conveniently run with multiple flasks without extensive reaction optimization. A typical flask fermentation is performed at 28 °C, 250 rpm with 100 mL culture in a 500 mL Erlenmeyer flask, although other settings will work fine too. Three parameters need to be investigated before scale-up the time for adding the substrate, the optimal substrate concentration and the time course of product formation. Optimization of other factors, such as medium composition and pH, growing cells versus resting cells [74], is helpful, if the timeline allows and if there is a sufficient amount of the substrate to support the screening. 

Gaps can be addressed by either facility modifications (which have capital expenditure implications) or process modifications (which have product implications) or indeed formulation modifications (which have potential regulatory implications). Other options may include selection of new equipment, rental or procurement options and the latter will impact on transfer cost and timelines. 

These plans envision composition-of-matter patents on drug molecules for which development timelines and market potentials can be estimated. Product stories are the clearest, most rational plans because profitable sales can be projected and rNPVs calculated. On the other hand, investors usually perceive higher risks because the rNPVs tend to be dominated by single product candidates for which historical failure rates are high. Examples of product stories include Amgen s development of Epogen and Amylin s development of Symlin. 

By developing a series of generic host production organisms, fermentation development time can be minimized when these host systems are used for production of multiple products. The investment of time and resources in developing the initial fermentation and recovery system can be recovered in subsequent programs in the form of more rapid commercial development timelines. 

The plan will eventually prescribe a likely filing date for a marketing authorisation application (MAA) (product hcence). This date is vital and when the plan becomes public information, any slippage in the date is likely to impact on the share price of the company. Accordingly, senior members of the company must be confident that the date can be met. There will always be pressure to bring the date forward but this has a cost in resources, and risks damaging credibility with investors if the accelerated timelines cannot be met. 

As things stand today, there are no shortcuts in drug development, regarding neither the overall development time—typically 12-15 years—nor the early identification of dropouts. The pharmaceutical industry will continue to have to contend with failure rates and timelines to bring products to market exceeding industry standards by far. 

Timelines 7. Blueprints of the pilot plant and production trains a. HH 5/5... 

This decision to scale-up is usually made two to three years before the projected regulatory filing date for the approval of the product, which in turn means about three to four years before the launch of the product. This is why the decision to scale-up is in direct opposition to the process development timeline, and special care has to be taken when developing a process for biologies in order for manufacturing not to be limitation on product approval. 

The main disadvantage of a continuous system is the long time required for validation and timely submission of produet applieation to the appropriate regulatory agency. This timeline is drastieally redueed with the use of a batch system of equivalent volumetric productivity. 

New Excipient Development Timeline Linked to First Pharmaceutical Product Development Timeline... 

The path which must be followed in the development of a material from lab bench to consumer is long, torturous and expensive. As stated before it takes about twelve years and over 200 million to bring an entity to the point of being marketed. Part of that timeline is understandable considering the laws governing safety and efficacy. Outlined in Figure 1 are the major steps on the way to a pharmaceutical product. 

During the construction phase of the project, we will make decisions on coordination options and permit requirements. We will discuss the various options available for the tracking of the project to ensure timelines are kept. Additionally, it is at this time when staffing requirements must be finalized. And a consideration of protocols, production records, and quality assurance documentation must be formalized. 

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