Operations

Manufacturing

Aktinos Pharma a distinct and rapidly evolved Indian Pharmaceutical company provides cost-competitive Contract Research and Manufacturing Services supporting R&D programs from process development to clinical supplies. Aktinos geared up to support and accelerate the development and manufacturing programs with increased efficiency, unwavering commitment to quality, wide therapeutic range, state-of-the-art research, global manufacturing capabilities, regulatory and intellectual property (IP) expertise.

Our multi-disciplinary skills include capabilities in synthetic medicinal chemistry, custom synthesis, process R&D, cGMP manufacturing, analytical development and regulatory support. Aktinos Pharma has state-of-the-art research facilities with USFDA, WHO GMP and ISO certified manufacturing units.

Aktinos Pharma caters to the synthetic chemistry part of drug development with well-experienced customer-centric scientific team and ensure timely execution and delivery of projects. Aktinos Pharma delivers significant value to its customers by leveraging its scientific skills, cost competitiveness, quality manufacturing, confidentiality and protection of intellectual property.

Aktinos Pharma works with a global network of approved raw material suppliers that provide highly specified starting material for pharmaceutical development.

Facility Description

Aktinos Pharma facility consists of
  • Chemical Development Labs (Synthesis & Analytical development)
  • Kilo Lab
  • CGMP Pilot Plant
  • Hydrogenation Plant
  • Intermediate and API Manufacturing Plant

R & D

Chemical Development Lab Infrastructure & Capabilities

  • Four state-of-the-art laboratories equipped with 30 standard fumehoods
  • Each lab equipped with dedicated chilled water circulation, vacuum and inert gas lines.
  • Kilo lab with All Glass Assembly reactors (20 L, 50 L, 100 L), Operating temperature range from – 70 °C to +180 ° C
  • Rotary Evaporators (20 L, 50 L)
  • SS 316 Hydrogenator : 2 L, 5 L, Pressure up to 25 kg/cm2 and Temperature range 5 ° C to +180 ° C
  • Necessary supporting equipments like filtration, drying, sieving, Milling and Micronisation.

Capabilities

  • Synthetic Route Design & Scouting
  • Chemical Process Development using latest techniques
  • Large-scale chromatography
  • Process Engineering (Data Generation) & Process Safety Studies (Process Hazard Analysis)
  • Integrated Salt Screening, Polymorph studies, Crystallisation technologies
  • Impurity Profiling (including impurity & reference standard synthesis), CPP studies
  • Genotoxicity and Nitrosamine risk assessments and control strategies
  • Kilo & Pilot Scale Manufacturing
  • Process Validation followed by Commercial Manufacturing

Reaction Capabilities

  • Grignard reaction
  • Chiral Reduction
  • Chemical Resolution
  • Organometallic reaction
  • Alkylation
  • Acylation
  • Glycosidation
  • Carbonylation
  • Azide formation
  • Peptide coupling
  • Sugar chemistry
  • Oxidation
  • Enzymatic reduction
  • Suzuki coupling
  • Wittig Reaction
  • Cyanation
  • Halogenation
  • Nitration
  • Reductive Amination
  • Catalytic Hydrogenation
  • Condensation
  • Cyclization
  • Diazotization
  • Mesylation
  • Methylation
  • Demethylation
  • Photocatalytic reaction
  • Cryogenic reaction

Other capabilities include Purification of liquid product by high vacuum distillation, handling of gaseous reagents, high temperature reactions (250oC), handling of pyrophoric reagents and high-pressure reactions (250 PSI).

Literature support

  • Strong Chemistry database support from SciFinder and online search engines.
  • For patent search - Google Patents, Espacenet, USPTO Web Patent Database, Patentscope by WIPO, Lens.org, etc.,
  • For journals and other publications search - Google scholar, WorldWideScience, PubMed Central, Science.gov, Microsoft Academic, Bielefeld Academic Search Engine (BASE), etc.,

Quality

The analytical department at Aktinos offers unique integrated analytical capabilities and expertise, delivering complete and high-quality packages of analytical services for drug discovery and development, customised for each phase – from early definitions to analytical tech transfer, in a fully validated GMP environment.

Aktinos Pharma analytics benefits from a broad range of analytical technique expertise and capabilities to provide for any development phase and API process development.

The strong Analytical chemistry team at Aktinos works closely with the Chemical Development and Tech-transfer teams and support all phases of development. Analytical lab is equipped with latest sophisticated analytical instruments like HPLC, GC-HS, IR, UV, Polarimeter, Automated titrator, LCMS etc.

Capabilities

  • Analytical method development for raw materials, intermediates and API
  • Method validations, Method verification and Method transfer
  • Impurity profiling – Synthesis, isolation and characterization
  • ICH Stability Studies & Support for Regulatory filing and approvals (CMC, DMF)
  • Complete evaluation and characterization of polymorphs
  • Strong and close cooperation with external partners for structural characterization equipments (NMR, Prep HPLC, PXRD, DSC, TGA, ICPMS), BET and Microbiological studies.

Manufacturing Capabilities

Aktinos Pharma involved in the manufacturing and supply of:
  • Key Starting Materials (KSMs)
  • Registered Starting Materials (RSMs)
  • Key GMP Intermediates
  • Commercial-scale APIs

Aktinos Pharma has the following manufacturing sites available for catering to the customer requirements.

CGMP Manufacturing Plant – Unit I: Hyderabad, India (Suitable for advance Intermediates, KSM, RSM)

Over 36 KL of reaction volume consisting of SS 316 & GLR reactors and Glass assemblies

  • Temperature range of – 80 ° C to +250 ° C
  • Capacity ranging from 50 L to 5000 L

Hydrogenation Plant:

  • Capacity : 1000 L, 1500 L
  • Temperature range: – 5 ° C to +150 ° C
  • Pressure up to 10 kg/cm2

CGMP Manufacturing plant – Unit II: Visakhapatnam, India (Suitable for advance Intermediates, KSM, RSM, API)

Over 228 KL of reaction volume consisting of MSGL, Glass assemblies and SS 316 reactors

  • Temperature range of – 80 ° C to +180 ° C
  • Capacity ranging from 50 L to 8500 L

Hydrogenation Plant:

  • Capacity : 250 L, 1000 L, 2000 L
  • Temperature range: – 5 ° C to +135 ° C
  • Pressure up to 20 kg/cm2
All manufacturing facilities well supported with appropriate:
  • Filtration Equipments: Centrifuge, Nutsche filters, Agitated Nutsche filter
  • Post Production Equipments: Tray Dryer, Vacuum tray Dryer, Fluid bed dryer, Multimill, Sifter, Micronizer, Blenders
  • Supporting Utilities
  • Solvent recovery plants
  • QC equipped with modern Analytical equipments