National Control Laboratories for Biologicals

Last Updated on February 23, 2022

INTRODUCTION

National Control Laboratory for Biologicals (NCLB) was established on July 10th, 2000 vide Statutory Regulatory Order No. 491(I)/ 2000 by the then Ministry of Health, Government of Pakistan. The main purpose for the creation of this specialized laboratory was the mandatory legal requirement of Section 7 of Schedule-I of DRAP Act, 2012 and Section 14 of the Drugs Act, 1976. It also fulfill the international obligation of World Health Organization (W.H.O.) to monitor the quality of locally produced and imported vaccines and blood products derived from human and animal blood.

After the promulgation of Drug Regulatory Authority of Pakistan (DRAP) Act, 2012 (XXXI of 2012),  under Section 3, Sub-section 4 of the DRAP Act, 2012, NCLB became part of the Authority. Under section 7 of Schedule-I of DRAP Act, 2012, all biological products defined in Schedule-I of DRAP Act, 2012 require lot release for sale and use from Federal Government Analyst of National Control Laboratory for Biologicals.

LEGAL REQUIREMENT

Section 7 of Schedule-I of DRAP Act, 2012

“No human biological drug is allowed sale and use until a “Lot Release Certificate” from the Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has been obtained.”

WHAT IS LOT RELEASE?

Lot release is a mechanism that provides DRAP with a real-time system to continuously monitor product quality, through review and testing, of many of the biological products that it regulates. It is a mandatory legal requirement under section 7 of Schedule-I of DRAP Act, 2012.

BATCH/ LOT RELEASE OF BIOLOGICAL MEDICINES IN THE PAKISTAN

The NCLB is the Pakistan’s Statutory and standalone National Control Laboratory and is therefore responsible for carrying out independent batch release testing of biological medicines.

LABORATORY STRUCTURE

NCLB is established over covered area of 28,000 SFT and comprised of following Blocks:-

  1. Microbiology Block
  2. Cell Culture Block
  3. Virology Testing Block
  4. Bacteriology Block
  5. Chemistry Block
  6. Quality Assurance & Archive Block
  7. Administration Block
  8. Animal & Plant Testing Rooms

TESTING FACILITIES

Independent assurance of quality is important for maintaining public confidence in biological medicines. NCLB has the capacity to perform following tests/ analysis-

  1. High Performance Liquid Chromatography (HPLC)
  2. Polymerase Chain Reaction
  3. Enzyme-Linked Immunosorbent Assay (ELISA)
  4. Gas Chromatography- Mass Spectrometry system
  5. Fourier-transform infrared spectroscopy (FTIR)
  6. Total Organic Carbon (TOC) Analyzer.
  7. Gel Documentation System
  8. SDS-Page Electrophoresis
  9. Osmolality Testing
  10. Sterility Testing
  11. Flocculation testing
  12. Cell Culture Area
  13. Innocuity (Abnormal Toxicity) Test
  14. Flowcytometry
  15. Karl Fisher (KF) Titration
  16. Residual moisture Analysis
  17. Protein Content
  18. Aluminum Content
  19. Bacterial Endotoxin Testing (BET)

TESTING CAPABILITY

NCLB has the capability to test a wide range of products including:

  1. Vaccines
  2. Albumins
  3. Therapeutic Antibodies
  4. Toxins and Antitoxins
  5. Blood Clotting and Anti-Clotting factors
  6. Plasma pools
  7. Cytokines
  8. Hormones and Growth Factors

NCLB MANAGEMENT

Sr. No.NameDesignationQualification
 1Dr. Mahvash AnsariAdditional DirectorPh.D. (Pharmaceutics), RPh
 2Mr. Zafar Mahmood MinhasDeputy DirectorM.Sc Microbiology
 3Miss Amna BibiFederal Government AnalystBachelor of Pharmacy, RPh
 4Mr. Muhammad Ayub NaveedManager Quality AssurancePharmD, M.Phil (Pharmaceutics), RPh
 5Mr. Khurram KhalidManager Laboratory OperationsM.Phil (Microbiology)
 6Mr. Zain ul AbidinManager QMSPharmD, M.Phil (Pharmacology), RPh

ORGANOGRAM

What is biological Drug
1. BIOLOGICALS includes,-

  • Biological drugs produced by biological systems and which require standardization by biological assays according to the relevant and updated recommendations of the World Health Organization published in Technical Report Series and Biological Standardization Report and includes-
  • blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clotting Factors Tractions, Fibrinogens, Immunoglobulins:
  • immunological products including Antisera, Antitoxins, specific Immunoglobulins;
  • in vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, Coccidioidin, Allergens, Allergens Extracts, Antibodies conjugated · with isotopes for imaging studies;
  • antigens, cytokines/antibodies/cells injected to elicit a biological response;
  • vaccines, including:
    • bacterial vaccines including live, killed whole cell, protein sub-unit, polysaccharide or Glyco-conjugate, toxin derivatives, and rDNA biotechnology b) developed.
    • viral vaccines including live, inactivated, sub-unit, rDNA, conjugated;
    • polyvalent combinations of vaccines containing combination of vaccines defined in e(i) and d(ii).
  • toxins and venoms including snake venoms, scorpion venoms etc;
  • immunostimulants of biological origin including BCG vaccine for immunotherapy;
  • biotechnology products which are primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology or other processes involving site specific genetic manipulation techniques
  • human interferons, natural hormones, recombinant antibodies, monoclonal antibodies and derivatives gene therapy products;

    2) Biological Drugs (Finished form) are Biological Drugs that are defined in sub-section (I) above and are manufactured, packed by the manufacturer under his responsibility of quality assurance and is further released by the National Control Authority or the National Control Laboratory of the country of origin under the World Health Organization’s Lot Release system of evaluation.
    3)Biological Drugs (Ready-to-fill form) are Biological Drugs that are defined in sub-section (1) above but are manufactured at one site in the form of a “Ready-to-fill Bulk” but are transferred to another site for final filling, labeling, packaging and quality control of the finished form. No further formulation or dilution · of the Ready-to-fill bulk is allowed in this case of manufacture. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.
    4)Biological Drugs (Concentrated form) are Biological Drugs that are defined in sub-section (I) above that are manufactured at one site but are stored in the form of Concentrated-Bulk of the active ingredient at controlled temperatures. Such Concentrated-Bulk may be transferred to any other site under temperature  controlled conditions for further dilution, stabilization, filling and packaging. The diluted and stabilized bulk requires its own set of quality control test and the final finished form of such Biological Drugs under go another set of complete quality control tests. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation.
    5)Biological Drugs (Naked vials) are Biologicals Drugs that are defined in sub-section {I) above that are manufactured and filled at one site but the final containers are neither labeled nor packed in cartons. These drugs are imported in unlabeled vials and are labeled and packed in carton locally. In such cases at least an identity test is required to confirm the positive identification of the required antigen. The final product is released by the Pakistan’s National Control Laboratory for Biologicals under the World Health Organization’s Lot Release system of evaluation: .
    6)Originator Biological Drugs means a biological drug which has been licensed by the national regulatory authorities on the basis of a full registration dossier; i.e. the approved indication(s) for use were granted on the basis of full quality, efficacy and safety data:
    • reference biotherapeutic product (RBP) means an originator biological drug product that was licensed on the basis of a full registration dossier. It does not refer to measurement standards such as international, pharmacopoeial, or national standards or reference standards;
    • biosimilar biological drugs mean Similar Biotherapeutic Product (SBP) which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product;
    • similarity means absence of a relevant difference in the parameter of interest.

CONTACT INFORMATION

National Control Laboratory for Biologicals

Prime Minister’s National Health Complex, Park Road, Chak Shahzad,      Islamabad-44000. Pakistan

Website:                    https://nclb.dra.gov.pk/
Email:                         Director@nclb.dra.gov.pk
Phone Number:        +92-51-9255263