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[Column] Management Strategies for Starting Materials in Active Pharmaceutical Ingredients

[Column] Management Strategies for Starting Materials in Active Pharmaceutical Ingredients

The selection of starting materials significantly impacts the manufacturing cost of active pharmaceutical ingredients. We would like to introduce our management strategy for starting materials in active pharmaceutical ingredient production.

The selection of starting materials (hereinafter referred to as starting materials) for applications is proposed by pharmaceutical companies in accordance with the general principles of ICH guideline Q11, but it is often the case that they receive frequent inquiries from authorities before approval. At SpiraPharma, when selecting starting materials, organic chemists and analytical chemists collaborate to propose which compounds are suitable as starting materials based on the manufacturing process. Additionally, when establishing management strategies for starting materials, we can obtain data to support responses to authorities through investigations of the behavior of key related substances. For our customers who are challenging the creation of new pharmaceuticals, we will continue to leverage our cultivated technology and experience while furthering our expertise. *For more detailed information on the column, please refer to the related link. For further inquiries, please feel free to contact us.

  • Other contract manufacturing

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Seminar on the Pharmaceutical Active Ingredient Manufacturing Process Utilizing Catalytic Asymmetric Synthesis

Seminar on the Pharmaceutical Active Ingredient Manufacturing Process Utilizing Catalytic Asymmetric Synthesis

[December 15 Event] A must-see for those involved in the synthesis of low molecular weight pharmaceuticals! Introduction to efforts in asymmetric synthesis reactions and more.

We are pleased to announce that our company will be hosting a webinar on "Pharmaceutical Active Ingredient Manufacturing Processes Utilizing Catalytic Asymmetric Synthesis" on December 15th (Thursday). In the synthesis of active pharmaceutical ingredients for low molecular weight drugs, when the target compound is a chiral compound with an asymmetric center, utilizing asymmetric synthesis that can synthesize the desired stereoisomer with high selectivity is extremely useful in the industry. At SpiraPharma, we have received requests from various customers to examine the asymmetric synthesis of target compounds, and we are advancing the application of asymmetric reactions centered on catalytic asymmetric hydrogenation to pharmaceutical processes. In this webinar, we will introduce our efforts in asymmetric synthesis reactions. We encourage anyone interested to participate. 【Event Overview】 ■ Date and Time: December 15th (Thursday) 11:00 AM - 11:30 AM ■ Participation: Free ■ Venue: Webinar via Teams *For more details, please refer to the related links or feel free to contact us.

  • Pharmaceutical materials and carriers

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Pharmaceutical Active Ingredient Division (Pharmaceutical Research Headquarters) Business and Technology

Pharmaceutical Active Ingredient Division (Pharmaceutical Research Headquarters) Business and Technology

Process optimization is possible! We propose a balanced active pharmaceutical ingredient development plan that considers speed, cost-effectiveness, and quality.

We would like to introduce our pharmaceutical active ingredient division (Pharmaceutical Research Headquarters) and its business and technology. We flexibly utilize a network of reliable partner contract manufacturers to build and propose an optimal active ingredient manufacturing supply chain tailored to specific purposes. With world-class pharmaceutical development technology and assured quality, we provide "the development of active ingredient manufacturing methods from 'zero' that meet global application requirements" and "a seamless and consistent active ingredient manufacturing process and quality design from preclinical stages to obtaining marketing approval." 【Features】 ■ Development of active ingredient manufacturing methods from 'zero' based on technology and know-how cultivated over many years at major domestic pharmaceutical companies. ■ Establishment of active ingredient manufacturing methods and quality design according to development stages and applications. ■ Flexible response to active ingredient manufacturing requests. ■ Accurate support for application processes (clinical trials and commercial use). *For more details, please refer to the PDF materials or feel free to contact us.

  • Other contract services
  • Technology Development

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[Technology and Achievements Introduction] Absorption Improvement Technology (Nanosized Formulation)

[Technology and Achievements Introduction] Absorption Improvement Technology (Nanosized Formulation)

Introducing the correlation diagram of particle size and surface area! It is applied to investigational drugs targeting compounds in the development stage.

We would like to introduce Spela Pharma's "Absorption Improvement Technology." By using nano-sized active pharmaceutical ingredients, we enhance bioavailability. We have successfully developed formulations using this technology and are applying it to investigational drugs targeting compounds in the development stage. On our website, we provide a correlation chart of particle size and surface area, as well as graphs showing plasma concentration in dogs for nano-particles and jet-milled active pharmaceutical ingredients, so please check the related links below. [Features] ■ Improved bioavailability through nano-sized active pharmaceutical ingredients ■ Successful development of formulations using this technology ■ Application to investigational drugs targeting compounds in the development stage *For more details, please refer to the PDF materials or feel free to contact us.

  • Other contract services
  • Technology Development

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[Thank You] CPhI Japan 2022

[Thank You] CPhI Japan 2022

Thank you for attending CPhI Japan 2022 (International Pharmaceutical Development Exhibition)!

Sperafarma exhibited at CPhI Japan 2022 (International Pharmaceutical Development Exhibition, April 20-22, Tokyo Big Sight) and welcomed many customers to our booth. As a CDMO capable of providing a wide range of services from early-stage R&D to the manufacturing of clinical trial drugs, commercial manufacturing, and raw material procurement, we will accelerate our support for pharmaceutical development. We would like to express our gratitude to everyone who provided us with opportunities for exchanging opinions and sharing information. 【Overview of Presentations at the Booth】 ■ Screening technologies required in active pharmaceutical ingredient research - catalyst selection, crystallization - ■ Mutagenic impurities in pharmaceuticals (active pharmaceutical ingredients) - development of testing methods and analysis examples - *For more details, please refer to the PDF materials or feel free to contact us.

  • Fine chemicals (compounds, derivatives, catalysts, etc.)
  • Other Testing Contract
  • Other analytical and testing equipment

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[CPhI Seminar Report] Mutagenic Impurities in Pharmaceuticals (Active Pharmaceutical Ingredients)

[CPhI Seminar Report] Mutagenic Impurities in Pharmaceuticals (Active Pharmaceutical Ingredients)

Development of testing methods and analysis examples! Established over 300 analytical methods that can guarantee PMI residues below 10 ppm!

At "CPhI Japan 2022," we held a presentation in our booth regarding ICH M7 compliance from the Development and Analytical Research Headquarters. We introduced the day's content, including "About ICH M7," "For the Development of Trace Analysis Methods," and "Examples of Method Validation." Please take a moment to read it. [Contents] ■ About ICH M7 ■ For the Development of Trace Analysis Methods ■ Examples of Method Validation ■ Conclusion *For more details, please refer to the related links page or feel free to contact us.

  • Other Testing Contract

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